Browse Device Recalls
153 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 153 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 153 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jun 11, 2025 | ROBOTIC PROSTATECTOMY PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | GYN LAPAROSCOPY PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | ROBOTIC URO/GYN PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | LAPAROSCOPIC TRAY. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | LAPAROSCOPIC GYN. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | LAVH PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | PACK GENERAL ROBOTIC. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | LAP CHOLE PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | GYN ROBOTIC PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Mar 31, 2025 | Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit. | An issue with a raw material used to coat some surgical needles that may result in diminished per... | Class II | AVID Medical, Inc. |
| Mar 31, 2025 | Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit. | An issue with a raw material used to coat some surgical needles that may result in diminished per... | Class II | AVID Medical, Inc. |
| Mar 31, 2025 | Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit | An issue with a raw material used to coat some surgical needles that may result in diminished per... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard EP PACK - Medical convenience kits Model Number: VANW018-06 | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25 | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02 | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number:... | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34 | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10 | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06 | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18 | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN... | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08 | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04 | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | Class II | AVID Medical, Inc. |
| Sep 20, 2024 | Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: V... | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... | 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.