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Browse Device Recalls

207 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 207 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 207 FDA device recalls.

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DateProductReasonClassFirm
Aug 10, 2026 PLASTICS TRAY; Model/Item Number (Kit): EURO053; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 HEART PREP TRAY; Model/Item Number (Kit): MECV97W; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 MAJOR PACK; Model/Item Number (Kit): NIHB0018-11; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH1... Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064... Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11; Product may be potentially contaminated with a lubricant used during the manufacturing process. Class II AVID Medical, Inc.
Aug 10, 2026 Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05; Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... Class I AVID Medical, Inc.
Aug 10, 2026 Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415; Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... Class I AVID Medical, Inc.
Aug 10, 2026 Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03; Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... Class I AVID Medical, Inc.
Aug 10, 2026 Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02; Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... Class I AVID Medical, Inc.
Jul 22, 2026 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep ... Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or i... Class II AVID Medical, Inc.
Jul 22, 2026 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep ... Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or i... Class II AVID Medical, Inc.
Jul 22, 2026 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep ... Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with... Class I AVID Medical, Inc.
Jul 14, 2026 Halyard IV START KIT NON-STERILE REF: KRIV26-02 Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are ... Class I AVID Medical, Inc.
Jul 14, 2026 Halyard IV Start Kit Non-Sterile REF: KRIV26-02 Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which la... Class II AVID Medical, Inc.
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 1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKC... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II AVID Medical, Inc.
May 19, 2026 Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (ki... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II AVID Medical, Inc.
May 19, 2026 Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/I... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... 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.

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.