Browse Device Recalls

3,179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,179 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 3,179 FDA device recalls.

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DateProductReasonClassFirm
Mar 3, 2017 Panta Nail, Rx only, Sterile, Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the ... Class II Integra LifeSciences Corp.
Mar 3, 2017 Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device t... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code:... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Jan 31, 2017 Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Ster... Product sterility compromised due to breach of sterile barrier Class II Degania Silicone, Ltd.
Jan 23, 2017 Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-... Sterility compromised due to breach in sterile barrier Class II Covidien LLC
Jan 23, 2017 Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphe... Sterility compromised due to breach in sterile barrier Class II Covidien LLC
Jan 18, 2017 BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for... The recalling firm received a complaint from one of their customers of a potential defect in the ... Class II Argon Medical Devices, Inc
Jan 18, 2017 T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEED... The recalling firm received a complaint from one of their customers of a potential defect in the ... Class II Argon Medical Devices, Inc
Jan 18, 2017 HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or... The recalling firm received a complaint from one of their customers of a potential defect in the ... Class II Argon Medical Devices, Inc
Jan 11, 2017 Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, pa... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Stem Pack, part number AMS5166 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Hernia Pack, part number AMS3859 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Bayview Abdominoplasty Pack, part number 009079-1 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Lower Extremity Pack, part number AMS4669 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Lap Gallbladder Pack, part number AMS3707 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Facial Plastic Pack, part number AMS3327(C The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Universal Pack, part number AMS2036 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Morris Lap Pack, part number PSS3199(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Angio Pack, part number AMS6711 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Brow Pack, part number PSS1785(C The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Extremity Pack-N Brunswick, part number PSS1866(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Plastic General Pack, part number AMS4215 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Facial Pack , part number AMS6501 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Dr Bragg Vein Tray - RX, part number 007912-8 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Plastic Kit, part number CMP1084(C The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AM... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B. The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Basic Pack (1185), part number AMS6560 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part n... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Set Up Pack, part number PSS3574(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Peri GYN, part number PSS2193(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 GYN Lap Pack, part number PSS2194(B The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Custom Breast Augmentation Pack, part number PSS2455(D The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Total Joint Pack, part number 006358-6 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Pod... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Head Pack, part number PSS1934(B The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Plastic Surgery Pack, part number AMS5685 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Custom Pack - with Introducer Kit, part number TVS4011NI(L The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Vein Tray, part number AMS6312 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Bleph Pack, part number AMS3325(B The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 General Plastic Pack, part number PSS2432(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 D & C Pack, part number AMS4796(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 General Laparoscopy Pack, part number AMS4798 General Laparoscopy Pack, part... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, 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.