Recall events
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Event 91124
Event summary
Timeline bucket November 02, 2022
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Stradis Medical, LLC dba Stradis Healthcare
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
78 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 78
STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
Z-0481-2023
Recall number Z-0481-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 80 kits
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0481-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33702]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information a) 9430: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22270492023 b) 9431: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22255491774, 22255491484
Distribution pattern US nationwide distribution, and Canada.
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[33465]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 78
ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
Z-0482-2023
Recall number Z-0482-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 10 kits
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0482-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33694]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75200338800, UDI/DI (kit)M75200338800, Serial/Lot Numbers: 22242490999
Distribution pattern US nationwide distribution, and Canada.
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[35763]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 78
STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
Z-0483-2023
Recall number Z-0483-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 25 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0483-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9960]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75220177RPSS1, UDI/DI (kit)M75220177RPSS0, Serial/Lot Numbers: 22263491083
Distribution pattern US nationwide distribution, and Canada.
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[36529]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 78
BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
Z-0484-2023
Recall number Z-0484-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 80 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0484-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58409]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75240310SBI1, UDI/DI (kit)M75240310SBI0, Serial/Lot Numbers: 22241489853
Distribution pattern US nationwide distribution, and Canada.
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[35322]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 78
STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
Z-0485-2023
Recall number Z-0485-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 12 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0485-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27972]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75240450SMS1, UDI/DI (kit)M75240450SMS0, Serial/Lot Numbers: 22262490676
Distribution pattern US nationwide distribution, and Canada.
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[36458]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 78
STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
Z-0486-2023
Recall number Z-0486-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 18 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0486-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4714]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75240510TWS1, UDI/DI (kit)M75240510TWS0, Serial/Lot Numbers: 22236490637
Distribution pattern US nationwide distribution, and Canada.
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[36127]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 78
STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
Z-0487-2023
Recall number Z-0487-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 6 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0487-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16656]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75240551TMS1, UDI/DI (kit)M75240551TMS0, Serial/Lot Numbers: 22230489112
Distribution pattern US nationwide distribution, and Canada.
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[35309]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 78
STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
Z-0488-2023
Recall number Z-0488-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0488-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45472]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75240561BIP1, UDI/DI (kit)M75240561BIP0, Serial/Lot Numbers: 22228490663, 22242491516, 22242491516
Distribution pattern US nationwide distribution, and Canada.
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[35787]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 78
STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
Z-0489-2023
Recall number Z-0489-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 6 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0489-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9938]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75240649ECS1, UDI/DI (kit)M75240649ECS0, Serial/Lot Numbers: 22270491425
Distribution pattern US nationwide distribution, and Canada.
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[35348]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0490-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 18 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0490-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16668]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75240714IES1, UDI/DI (kit)M75240714IES0, Serial/Lot Numbers: 22229490633, 22229490633, 22229490633
Distribution pattern US nationwide distribution, and Canada.
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[32786]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0491-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 6 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0491-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16678]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75240788SMS1, UDI/DI (kit)M75240788SMS0, Serial/Lot Numbers: 22234489435
Distribution pattern US nationwide distribution, and Canada.
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[32899]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0492-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 180 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0492-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58415]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75240996WLS1, UDI/DI (kit)M75240996WLS0, Serial/Lot Numbers: 22230489371
Distribution pattern US nationwide distribution, and Canada.
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[32794]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0493-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 30 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0493-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45512]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75241015NSI1, UDI/DI (kit)M75241015NSI0, Serial/Lot Numbers: 22230491043
Distribution pattern US nationwide distribution, and Canada.
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[33746]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0494-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 162 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0494-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51854]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7524111UTI0, UDI/DI (kit)M7524111UTI0, Serial/Lot Numbers: 22229491074
Distribution pattern US nationwide distribution, and Canada.
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[35705]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0495-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0495-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45470]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75241137TDS1, UDI/DI (kit)M75241137TDS0, Serial/Lot Numbers: 22230489097
Distribution pattern US nationwide distribution, and Canada.
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[35912]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0496-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 12 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0496-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4694]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75241213ATCP1, UDI/DI (kit)M75241213ATCP0, Serial/Lot Numbers: 22262491452
Distribution pattern US nationwide distribution, and Canada.
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[32868]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0497-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0497-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9961]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75241236SDSP1, UDI/DI (kit)M75241236SDSP0, Serial/Lot Numbers: 22235489632
Distribution pattern US nationwide distribution, and Canada.
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[35962]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0498-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 100 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0498-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21811]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7525050101, UDI/DI (kit)M7525050100, Serial/Lot Numbers: 22269491064,
Distribution pattern US nationwide distribution, and Canada.
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[33729]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0499-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 100 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0499-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16665]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7525150011, UDI/DI (kit)M7525150011, Serial/Lot Numbers: 22258491483
Distribution pattern US nationwide distribution, and Canada.
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[33845]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0500-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 180 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0500-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9964]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7525250381, UDI/DI (kit)M7525250380, Serial/Lot Numbers: 22251491752,
Distribution pattern US nationwide distribution, and Canada.
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[36104]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0501-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 150 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0501-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27996]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7525250711, UDI/DI (kit)M7525250710, Serial/Lot Numbers: 22252491061
Distribution pattern US nationwide distribution, and Canada.
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[32859]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0502-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 10 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0502-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45473]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857006111, UDI/DI (kit)M75257006110, Serial/Lot Numbers: 22257490683
Distribution pattern US nationwide distribution, and Canada.
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[35888]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0503-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 800 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0503-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51848]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857014261, UDI/DI (kit)M75257014260, Serial/Lot Numbers: 22257490682
Distribution pattern US nationwide distribution, and Canada.
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[32847]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0504-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 15 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0504-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4739]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857014621, UDI/DI (kit)M75257014620, Serial/Lot Numbers: 22230491082
Distribution pattern US nationwide distribution, and Canada.
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[32766]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0505-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0505-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4719]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75257014821, UDI/DI (kit)M75257014820, Serial/Lot Numbers: 22235489736
Distribution pattern US nationwide distribution, and Canada.
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[32797]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0506-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 35 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0506-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33707]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857015081, UDI/DI (kit)M75257015080, Serial/Lot Numbers: 22252490204
Distribution pattern US nationwide distribution, and Canada.
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[33649]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0507-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 30 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0507-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51892]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857016921, UDI/DI (kit)M75257016920, Serial/Lot Numbers: 22257490755
Distribution pattern US nationwide distribution, and Canada.
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[33739]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0508-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 96 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0508-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51853]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857018031, UDI/DI (kit)M75257018030, Serial/Lot Numbers: 22258490734
Distribution pattern US nationwide distribution, and Canada.
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[33624]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0509-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 8 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0509-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33698]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857023971, UDI/DI (kit)M75257023970, Serial/Lot Numbers: 22235489451
Distribution pattern US nationwide distribution, and Canada.
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[35361]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0510-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0510-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21812]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857026251, UDI/DI (kit)M75257026250, Serial/Lot Numbers: 22230491067
Distribution pattern US nationwide distribution, and Canada.
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[35919]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0511-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 104 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0511-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9937]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857027181, UDI/DI (kit)M75257027180, Serial/Lot Numbers: 22242489582, 22256491864
Distribution pattern US nationwide distribution, and Canada.
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[35882]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0512-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 24 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0512-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4704]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857027181, UDI/DI (kit)M75257027180, Serial/Lot Numbers: 22242489582
Distribution pattern US nationwide distribution, and Canada.
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[35301]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0513-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 18 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0513-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45463]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857027381, UDI/DI (kit)M75257027380, Serial/Lot Numbers: 22257490591
Distribution pattern US nationwide distribution, and Canada.
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[36477]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0514-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 12 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0514-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33714]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857027421, UDI/DI (kit)M75257027420, Serial/Lot Numbers: 22252489778
Distribution pattern US nationwide distribution, and Canada.
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[35896]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0515-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 90 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0515-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4712]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857027791, UDI/DI (kit)M75257027790, Serial/Lot Numbers: 22262489585, 22270490757
Distribution pattern US nationwide distribution, and Canada.
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[33671]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0516-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 5 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0516-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21818]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857027831, UDI/DI (kit)M75257027830, Serial/Lot Numbers: 22234489305
Distribution pattern US nationwide distribution, and Canada.
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[36461]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0517-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 675 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0517-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39899]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857027871, UDI/DI (kit)M75257027870, Serial/Lot Numbers: 22262491981
Distribution pattern US nationwide distribution, and Canada.
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[36452]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0518-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 100 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0518-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33708]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857027891, UDI/DI (kit)M75257027890, Serial/Lot Numbers: 22252491561
Distribution pattern US nationwide distribution, and Canada.
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[36474]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0519-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 18 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0519-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4718]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857027931, UDI/DI (kit)M75257027930, Serial/Lot Numbers: 22241489575
Distribution pattern US nationwide distribution, and Canada.
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[32769]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0520-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 24 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0520-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16674]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857028831, UDI/DI (kit)M75257028831, Serial/Lot Numbers: 22229489323
Distribution pattern US nationwide distribution, and Canada.
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[32812]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0521-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 25 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0521-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58444]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857028901, UDI/DI (kit)M75257028900, Serial/Lot Numbers: 22262492001
Distribution pattern US nationwide distribution, and Canada.
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[32826]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0522-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 144 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0522-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27980]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857028911, UDI/DI (kit)M75257028910, Serial/Lot Numbers: 22252491813
Distribution pattern US nationwide distribution, and Canada.
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[33377]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0523-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 10 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0523-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58410]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857029001, UDI/DI (kit)M75257029000, Serial/Lot Numbers: 22252489760
Distribution pattern US nationwide distribution, and Canada.
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[35866]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0524-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 48 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0524-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4701]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857029081, UDI/DI (kit)M75257029080, Serial/Lot Numbers: 22241489773
Distribution pattern US nationwide distribution, and Canada.
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[36494]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0525-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 16 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0525-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21807]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857029301, UDI/DI (kit)M75257029300, Serial/Lot Numbers: 22235490920
Distribution pattern US nationwide distribution, and Canada.
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[32798]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0526-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 144 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0526-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58408]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857029461, UDI/DI (kit)M75257029460, Serial/Lot Numbers: 22242490745
Distribution pattern US nationwide distribution, and Canada.
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[36470]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0527-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 510 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0527-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4697]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857030591, UDI/DI (kit)M75257030590, Serial/Lot Numbers: 22257487536
Distribution pattern US nationwide distribution, and Canada.
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[32856]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0528-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 328 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0528-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39910]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857030701, UDI/DI (kit)M75257030700, Serial/Lot Numbers: 22235491255, 22241491256
Distribution pattern US nationwide distribution, and Canada.
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[32851]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0529-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 27 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0529-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21821]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857030721, UDI/DI (kit)M75257030720, Serial/Lot Numbers: 22241490953
Distribution pattern US nationwide distribution, and Canada.
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[33827]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0530-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 80 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0530-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27990]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857030891, UDI/DI (kit)M75257030890, Serial/Lot Numbers: 22251491690
Distribution pattern US nationwide distribution, and Canada.
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[35691]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0531-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 72 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0531-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9943]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857030911, UDI/DI (kit)M75257030910, Serial/Lot Numbers: 22258490762
Distribution pattern US nationwide distribution, and Canada.
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[35876]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0532-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 581 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0532-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9946]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857030921, UDI/DI (kit)M75257030920, Serial/Lot Numbers: 22231491193
Distribution pattern US nationwide distribution, and Canada.
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[35747]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0533-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 42 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0533-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27992]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857031181, UDI/DI (kit)M75257031180, Serial/Lot Numbers: 22234491292
Distribution pattern US nationwide distribution, and Canada.
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[33393]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0534-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 140 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0534-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33717]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65857031311, UDI/DI (kit)M75257031310, Serial/Lot Numbers: 22257490596
Distribution pattern US nationwide distribution, and Canada.
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[32928]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0535-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 300 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0535-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51861]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75260060GCTS1, UDI/DI (kit)M75260060GCTS0, Serial/Lot Numbers: 22257490438
Distribution pattern US nationwide distribution, and Canada.
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[36052]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0536-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 6 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0536-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9944]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526812541, UDI/DI (kit)M7526812540, Serial/Lot Numbers: 22270492010
Distribution pattern US nationwide distribution, and Canada.
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[32842]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0537-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 15 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0537-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39903]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526820011, UDI/DI (kit)M7526820010, Serial/Lot Numbers: 22236489633
Distribution pattern US nationwide distribution, and Canada.
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[32832]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0538-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 5 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0538-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27973]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7268212281, UDI/DI (kit)M7268212280, Serial/Lot Numbers: 22237491041
Distribution pattern US nationwide distribution, and Canada.
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[33478]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0539-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 40 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0539-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16664]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526821301, UDI/DI (kit)M7526821300, Serial/Lot Numbers: 22237491040
Distribution pattern US nationwide distribution, and Canada.
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[35931]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0540-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0540-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27989]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75268214251, UDI/DI (kit)M75268214250, Serial/Lot Numbers: 22236490624
Distribution pattern US nationwide distribution, and Canada.
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[33389]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0541-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0541-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51850]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75268215831, UDI/DI (kit)M75268215830, Serial/Lot Numbers: 22237491038
Distribution pattern US nationwide distribution, and Canada.
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[35859]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0542-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 40 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0542-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58441]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75268217281, UDI/DI (kit)M75268217280, Serial/Lot Numbers: 22235489419
Distribution pattern US nationwide distribution, and Canada.
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[35696]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0543-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 10 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0543-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16669]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75268217321, UDI/DI (kit)M75268217320, Serial/Lot Numbers: 22230489185
Distribution pattern US nationwide distribution, and Canada.
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[33422]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0544-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 100 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0544-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39906]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M75268219371, UDI/DI (kit)M75268219370, Serial/Lot Numbers: 22237490509
Distribution pattern US nationwide distribution, and Canada.
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[33371]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0545-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 400 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0545-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39892]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526821942NL11, UDI/DI (kit)M7526821942NL10, Serial/Lot Numbers: 22251491808
Distribution pattern US nationwide distribution, and Canada.
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[35351]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0546-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 30 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0546-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27981]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526821993R11, UDI/DI (kit)M7526821993R10, Serial/Lot Numbers: 22235491208
Distribution pattern US nationwide distribution, and Canada.
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[36440]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0547-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 40 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0547-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27993]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526823301, UDI/DI (kit)M7526823300, Serial/Lot Numbers: 22238490518
Distribution pattern US nationwide distribution, and Canada.
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[32824]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0548-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 10 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0548-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33703]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M752682334R11, UDI/DI (kit)M752682334R10, Serial/Lot Numbers: 22231489619
Distribution pattern US nationwide distribution, and Canada.
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[33431]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0549-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 10 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0549-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4695]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526824941, UDI/DI (kit)M7526824940, Serial/Lot Numbers: 22234489198
Distribution pattern US nationwide distribution, and Canada.
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[32806]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0550-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 25 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0550-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58417]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526825091, UDI/DI (kit)M7526825090, Serial/Lot Numbers: 22256490827
Distribution pattern US nationwide distribution, and Canada.
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[35806]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0551-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 15 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0551-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4698]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526825771, UDI/DI (kit)M7526585770, Serial/Lot Numbers: 22230490618
Distribution pattern US nationwide distribution, and Canada.
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[33439]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0552-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 105 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0552-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45480]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526829471, UDI/DI (kit)M7526829470, Serial/Lot Numbers: 22236491032
Distribution pattern US nationwide distribution, and Canada.
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[35840]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0553-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 10
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0553-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58446]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526861421, UDI/DI (kit)M7526861420, Serial/Lot Numbers: 22236491028
Distribution pattern US nationwide distribution, and Canada.
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[33687]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0554-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 24 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0554-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4707]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526861991, UDI/DI (kit)M7526861990, Serial/Lot Numbers: 22236491017
Distribution pattern US nationwide distribution, and Canada.
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[33693]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0555-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 16 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0555-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9955]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M7526932761, UDI/DI (kit)M7526932760, Serial/Lot Numbers: 22242490001
Distribution pattern US nationwide distribution, and Canada.
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[35759]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0556-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 304 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0556-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45478]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65888825201, UDI/DI (kit)M75288825200, Serial/Lot Numbers: 22256490684
Distribution pattern US nationwide distribution, and Canada.
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[35782]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0557-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0557-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45511]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) H65888825491, UDI/DI (kit)M75288825490, Serial/Lot Numbers: 22230489459
Distribution pattern US nationwide distribution, and Canada.
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[36430]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0558-2023
Initiated November 02, 2022
Classification Class II
Status Ongoing
Quantity 75 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0
bag being incompletely sealed, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0558-2023
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21813]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Code information UDI/DI (case) M752SS0772251, UDI/DI (kit)M752SS0772251, Serial/Lot Numbers: 22255490439
Distribution pattern US nationwide distribution, and Canada.
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[33795]
FDA event record
· Exact recall-number query on openFDA
