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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

180 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 180 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 180 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 10, 2026 Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visua... The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation,... Class II AVID Medical, Inc.
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY ... Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
Jul 9, 2026 Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... Class II AVID Medical, Inc.
May 19, 2026 Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. C... Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper s... Class II AVID Medical, Inc.
May 7, 2026 Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit. Incorrect concentration of Betadine solution contained within certain AVID convenience kits. Class II AVID Medical, Inc.
Apr 30, 2026 Halyard convenience kits containing recalled Medline Namic Angiographic Star ... Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... Class I AVID Medical, Inc.
Apr 30, 2026 Halyard convenience kits containing recalled Medline Namic Angiographic Star ... Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... Class I AVID Medical, Inc.
Apr 30, 2026 Halyard convenience kits containing recalled Medline Namic Angiographic Star ... Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... Class I AVID Medical, Inc.
Apr 30, 2026 Halyard, Eye Bag Pack. Kit Code: UIEB48-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Class II AVID Medical, Inc.
Apr 30, 2026 Halyard, Drape Pack. Kit Code: LMDP36-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Class II AVID Medical, Inc.
Apr 30, 2026 Halyard, Pain Pack. Kit Code: AMPK48-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Class II AVID Medical, Inc.
Apr 30, 2026 Halyard, Towel Six Pack. Kit Code: AMTS70-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Class II AVID Medical, Inc.
Mar 13, 2026 Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard CATH LAB kit. Model Number: SACL75AM. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard CATH LAB kit. Model Number: SACL75-01. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Mar 13, 2026 Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... Class I AVID Medical, Inc.
Jan 2, 2026 Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. Tyvek bag seal issue which may compromise sterility of the kit. Class II AVID Medical, Inc.
Nov 14, 2025 Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10. Potential for incomplete seal on header bag. Class II AVID Medical, Inc.
Nov 14, 2025 Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09. Potential for incomplete seal on header bag. Class II AVID Medical, Inc.
Nov 14, 2025 Halyard, MAJOR PACK. Catalog Number: JEMJ10-01. Potential for incomplete seal on header bag. Class II AVID Medical, Inc.
Nov 14, 2025 Halyard, EP LAB PK. Catalog Number: ESJH009-03. Potential for incomplete seal on header bag. Class II AVID Medical, Inc.
Nov 14, 2025 Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01. Potential for incomplete seal on header bag. Class II AVID Medical, Inc.
Nov 11, 2025 Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 Devices are not suitable for organ transplant. Class I AVID Medical, Inc.
Nov 11, 2025 Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. Devices are not suitable for organ transplant. Class I AVID Medical, Inc.
Nov 11, 2025 Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17. Devices are not suitable for organ transplant. Class I AVID Medical, Inc.
Aug 4, 2025 Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit. Potential for open header bag seals, compromising sterility. Class II AVID Medical, Inc.
Aug 4, 2025 Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit. Potential for open header bag seals, compromising sterility. Class II AVID Medical, Inc.
Jun 11, 2025 DA VINCI PACK URO/PROSTATE. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 CT DAVINCI. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 GS ENDOSCOPY PACK. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 DAVINCI UROLOGY. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 CARDIAC ROBOT PACK. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 GENERAL ROBOTIC PACK. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 HVI CARDIAC ROBOT PACK. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 PARTIAL NEPHRECTOMY PACK. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 MAJOR THORACOSCOPY BASIN. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 LAPAROSCOPY PACK. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 GEN LAPAROSCOPY PACK. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.
Jun 11, 2025 GENERAL LAPAROSCOPY TRAY. Medical convenience kit. CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Class II AVID Medical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.