Recall events
/
Event 76059
Event summary
Timeline bucket October 06, 2016
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording The Anspach Effort, Inc.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
103 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
Recall number Z-1930-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1930-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34260]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD14.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11151]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1931-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 19
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1931-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14989]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AL-III-DISS-20
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8501]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1932-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 17
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1932-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3838]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040 Part No. AL-III-DISS-30
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9837]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1933-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 1
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1933-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20650]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AL-III-IRR
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10686]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1934-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 239
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1934-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38532]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8543]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1935-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 16
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1935-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45582]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-20
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11139]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1936-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 5
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1936-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11080]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-DISS
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11083]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1937-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 17
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1937-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56261]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-FG
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9027]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1938-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 51
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1938-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51297]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-IRR
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8606]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1939-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 1
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1939-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14983]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-NK
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9842]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1940-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 41
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1940-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11072]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0062; Part No. BBLACK
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9029]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1941-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 25
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1941-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27557]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. BLACKMAX-N-LP
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10690]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1942-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 3
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1942-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14984]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0093; Part No. IMRI-FOOT-CTRL
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10699]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1943-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 3
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1943-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51296]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0093; Part No. IMRI-MOTOR
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11081]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1944-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 554
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1944-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20645]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. xMAX.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11116]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1945-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 22
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1945-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34251]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0040; Part No. xMAX-H. Device Listing No. D015777.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11122]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1946-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 207
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1946-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27536]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP-DIR/RR
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8249]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1947-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 32
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1947-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38534]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-HC.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7532]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1948-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 209
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1948-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56253]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP-DIR.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8520]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1949-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 821
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1949-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27534]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8516]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1950-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 158
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1950-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56258]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. eMax2.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12915]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1951-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 293
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1951-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34242]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. eMax2-HC.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8582]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1952-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 3,434
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1952-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34248]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EMAX2PLUS.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11106]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1953-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 320
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1953-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3839]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EPLUS-FP.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11074]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1954-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 22
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1954-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34258]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EPLUS-FP-NS.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8257]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1955-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 439
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1955-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56260]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. SC2100.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9823]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1956-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 462
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1956-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38528]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. SC2101.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11117]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1957-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 239
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1957-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38530]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All product shipped prior to 09/27/2016; DFU 18-0085; Part No. SC2102.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9854]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1958-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 198
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1958-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45583]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0048; Part No. ADG.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8566]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1959-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 41
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1959-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34252]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-BLACK.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12900]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1960-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 216
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1960-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27537]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-BLUE-S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10626]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1961-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 31
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1961-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27535]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-GOLD.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9828]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1962-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 148
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1962-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34245]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREEN.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11149]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1963-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 8
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1963-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45618]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREEN-R.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12918]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1964-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 6
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1964-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45594]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREY-ADG.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11131]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1965-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 4
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1965-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11078]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREY-MIA16.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9849]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1966-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 5
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1966-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11070]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0095; Part No. BM-DRIVER.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8209]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1967-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 25
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1967-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34243]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-L.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8579]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1968-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 17
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1968-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3835]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-M.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8510]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1969-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 11
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1969-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34250]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11095]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1970-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 2
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1970-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3833]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-ORANGE-45.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8597]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1971-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 10
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1971-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3837]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-ORANGE-90.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10663]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1972-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 45
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1972-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11081]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD11.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9845]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1973-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 13
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1973-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3847]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD11-S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8568]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1974-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 17
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1974-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14994]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD14.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11129]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1975-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 1
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1975-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20649]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD14-S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9864]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1976-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 1
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1976-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34240]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD8.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12907]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1977-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 3
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1977-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45590]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD8-S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9860]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1978-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 16
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1978-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11075]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers; DFU 18-0062; Part No. B-RED.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12926]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1979-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 5
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1979-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15000]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-SAGITTAL.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8562]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1980-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 297
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1980-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3842]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-SILVER.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9844]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1981-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 297
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1981-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34259]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQ-L.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10695]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1982-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 49
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1982-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56246]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQUOISE.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9820]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1983-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 3
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1983-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38536]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQ-X.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9002]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1984-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 80
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1984-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20643]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-Violet.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9832]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1985-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 4
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1985-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45585]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CDA.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7530]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1986-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 2878
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1986-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56247]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. Crani-A.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10644]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1987-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 130
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1987-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45596]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-A-01.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11058]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1988-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 49
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1988-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3846]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-A-R.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8260]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1989-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 930
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1989-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34244]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-L.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7508]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1990-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 8
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1990-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3836]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-L-R.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11113]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1991-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 679
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1991-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45588]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-P.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12911]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1992-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 714
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1992-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3841]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0097; Part No. CSR60.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12923]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1993-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 128
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1993-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45595]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0097; Part No. CSR60BM.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11121]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1994-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 8
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1994-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14995]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. C-SYSTEM.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8197]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1995-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 121
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1995-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51295]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. DRIVER.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8264]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1996-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 10
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1996-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45587]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-CRANI-A.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9025]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1997-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 14
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1997-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51305]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-SHORT.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11144]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1998-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 5
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1998-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20647]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-SHORT-HD.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10620]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1999-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 3504
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1999-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38535]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12931]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2000-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 4
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2000-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11071]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-01.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8599]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2001-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 9829
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2001-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11082]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-HD.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11091]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2002-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 247
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2002-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11066]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10671]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2003-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 182
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2003-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56259]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-10C.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9007]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2004-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 112
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2004-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56248]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-10S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10677]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2005-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 224
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2005-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34241]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15C.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12916]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2006-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 568
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2006-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51303]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[12934]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2007-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 121
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2007-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51302]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15ST.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8185]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2008-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 58
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2008-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56245]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-19ST.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8592]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2009-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 618
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2009-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45591]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-D21.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8555]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2010-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 22
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2010-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34246]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-D20BM.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9821]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2011-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 98
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2011-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27538]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-Driver.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8203]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2012-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 1802
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2012-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3840]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MEDIUM.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9815]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2013-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 1202
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2013-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20651]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MEDIUM-HD.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8524]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2014-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 177
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2014-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34261]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MIA16.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10625]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2015-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 22
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2015-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34256]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MM-SAGITTAL.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8190]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2016-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 119
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2016-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11073]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0100; Part No. OCM.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10622]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2017-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 5
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2017-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45593]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0030; Part No. ORANGE-45.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9836]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2018-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2018-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11076]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0030; Part No. ORANGE-90.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9848]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2019-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 16
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2019-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34239]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. O-SAW.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9018]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2020-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 455
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2020-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14997]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD11.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8541]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2021-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 203
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2021-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14996]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD11-S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10657]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2022-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 238
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2022-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11067]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD14.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8623]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2023-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 91
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2023-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51301]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD14-S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11111]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2024-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 415
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2024-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51298]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD8.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10679]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2025-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 375
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2025-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15002]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD8-S.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8601]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2026-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 65
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2026-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51304]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. R-SAW.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8530]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2027-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 50
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2027-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34249]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. SA-JACOBS.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[9017]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2028-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 16
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2028-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14988]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. SA-JLATCH.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8554]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2029-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 5757
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2029-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56251]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. SHORT.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[11141]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2030-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 2339
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2030-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51299]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. SHORT-HD.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10633]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2031-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 62
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2031-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34253]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. S-SAW.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[10629]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2032-2017
Initiated October 06, 2016
Classification Class II
Status Terminated
Quantity 206
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Supplied Directions for Use (DFU) did not contain a recommended service interval.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2032-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11077]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. XL-HD.
Distribution pattern Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[8219]
FDA event record
· Exact recall-number query on openFDA
