Recall events
/
Event 82927
Event summary
Timeline bucket April 30, 2019
Product types Device
Classifications Class II
Statuses Completed
Recalling firm wording Cardinal Health 200, LLC
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
17 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.
device · product 1 of 17
Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
Z-2036-2019
Recall number Z-2036-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2036-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51034]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 904218, 904918, 906329
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[29528]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 17
Monoject Standard Hypodermic Needle Item code: 8881200029
Z-2037-2019
Recall number Z-2037-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2037-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56447]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 904956
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[29104]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 17
Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
Z-2038-2019
Recall number Z-2038-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2038-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27216]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number:904212, 905612, 907002
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28871]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 17
Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
Z-2039-2019
Recall number Z-2039-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2039-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44615]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 905613
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[29108]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 17
Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078
Z-2040-2019
Recall number Z-2040-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2040-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16105]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 907007
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28865]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 17
Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
Z-2041-2019
Recall number Z-2041-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2041-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44614]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 904901
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[29292]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 17
Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
Z-2042-2019
Recall number Z-2042-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2042-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3999]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 905657, 906327, 906341
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28822]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 17
Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456
Z-2043-2019
Recall number Z-2043-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2043-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10684]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 909117
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28742]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 17
Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
Z-2044-2019
Recall number Z-2044-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2044-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56456]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 905611
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28746]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2045-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2045-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21660]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 905662
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[29431]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2046-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2046-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16102]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 904219, 904220, 907710
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[29452]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2047-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2047-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51032]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 902108
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28410]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2048-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2048-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51035]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 905659, 905660, 906343
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28838]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2049-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2049-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33088]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 902110, 902111
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28795]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2050-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2050-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16106]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 905617, 905618, 905619, 905620, 907004, 907005
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28879]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2051-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2051-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27224]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 907734
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28983]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2052-2019
Initiated April 30, 2019
Classification Class II
Status Completed
Quantity N/A
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
Manufacturing defect
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-2052-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38635]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information Lot Number: 903530
Distribution pattern Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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[28732]
FDA event record
· Exact recall-number query on openFDA
