Recall events
/
Event 87958
Event summary
Timeline bucket April 29, 2021
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Exact Medical Manufacturing, 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
18 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 18
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
Z-1907-2021
Recall number Z-1907-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 8800 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1907-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58314]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1907E366 1908E436 1910E101 1910E444 1912E463 2003E605 2005E438 2008E091 2012E096 2012E103
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[32614]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 18
Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
Z-1908-2021
Recall number Z-1908-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 1600 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1908-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33483]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1908E209 1908E435 2005E171 2007E030
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[34134]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 18
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
Z-1909-2021
Recall number Z-1909-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 17545 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1909-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15564]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1912E126 2002E133 2008E227 2008E226
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[32640]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 18
6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
Z-1910-2021
Recall number Z-1910-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 7920 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1910-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9333]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1907E386 1911E049 1911E047 1911E261 1912E129 1912E128 2003E604 2003E633 2003E240 2003E932 2003E931 2005E439 2007E257 2010E215 2012E099 2012E506 2101E071
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[34093]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 18
Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
Z-1911-2021
Recall number Z-1911-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 12650 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1911-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21770]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 2003E829 2003E242 2004E033 2005E165 2005E164 2005E176 2005E440 2011E107 2011E250 2101E070 2012E509
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[35106]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 18
6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
Z-1912-2021
Recall number Z-1912-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 9680 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1912-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15568]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1912E127 2003E794 2002E132 2003E801 2004E024 2004E514 2009E127 2008E357 2009E467 2009E250 2011E108 2012E100 2012E104
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[34119]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 18
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
Z-1913-2021
Recall number Z-1913-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 5621 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1913-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33484]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1907E241 1909E199 1908E437 1912E125 2003E828 2005E443 2005E175
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[34170]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 18
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Z-1914-2021
Recall number Z-1914-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 129600 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1914-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45188]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1906E228 1907E501 1908E562 1910E027 1910E345 1911E263 1912E541 2003E241 2003E830 2010E342 2011E403
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[32648]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 18
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
Z-1915-2021
Recall number Z-1915-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 100600 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1915-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33481]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 2003E690 2006E079 2004E015 2007E001 2006E079 2007E002 2010E361 2101E329 2011E271
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[32639]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1916-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 500 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1916-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15562]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 2003E691
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[35133]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1917-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 51300 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1917-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45189]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1906E310 1908E208 1908E561 1910E032 1910E350 1911E262 1912E540 2003E308 2002E135 2003E324 2004E513 2009E129 2009E408 2101E069 2011E404
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[34162]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1918-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 10020 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1918-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9350]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 2005E090 2006E495
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[32831]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1919-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 3000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1919-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21746]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 2005E091
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[32846]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1920-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 78000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1920-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45184]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1909E197 1910E296 1911E050 2002E180 2004E028
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[32892]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1921-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 33250 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1921-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58298]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 2008E475 2009E247 2010E217 2012E102 2012E191
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[32888]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1922-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 36000
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1922-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21747]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1910E448 2009E249 2009E248 2010E214 2011E249
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[32875]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1923-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 800 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1923-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4880]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 1909E198 1911E260 2011E248
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[32837]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1924-2021
Initiated April 29, 2021
Classification Class II
Status Terminated
Quantity 6000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
No 510k for the product to be used in a natural or surgical opening to the body
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
No Marketing Application
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1924-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21750]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall No 510k for the product to be used in a natural or surgical opening to the body
Code information Lot Numbers: 2002E015 2011E316
Distribution pattern US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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[35120]
FDA event record
· Exact recall-number query on openFDA
