Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Sep 24, 2024 medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 23, 2024 KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40),... The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek s... Class II Pro-Dex Inc
Sep 22, 2024 ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of EL... Potential challenge with intraoperative assembly of the external taper of a single midsection wit... Class II Onkos Surgical, Inc.
Sep 20, 2024 SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and sur... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard ANGIO TRAY - Medical convenience kits Model Number: VAPX021-05 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19 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 PACK - Medical convenience kits Model Number: SJCS66-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ENT - Medical convenience kits Model Number: VMED011-01 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAM... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CO... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties a... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
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.
Sep 20, 2024 SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surg... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
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 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 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 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 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 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 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 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 SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and su... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
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 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 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 ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgica... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgica... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 remel BactiDrop Acridine Orange, REF 21502, 50 per package. A color change of the solution within the dropper can occur from orange-yellow to light yellow re... Class II Remel, Inc
Sep 20, 2024 Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06 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.