Browse Device Recalls

315 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 315 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 315 FDA device recalls.

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DateProductReasonClassFirm
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.
Jan 11, 2017 Lap/Pelviscopy Pack, part number PSS3256(B The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Ortho Minor Pack, part number AMS3710(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Lipo Pack, part AMS4420(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Catheter Pack, part number AMS4399(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pac... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Hystero Pack, part number PSS3535(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Upper Extremity Pack, part number AMS4670 Upper Extremity 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 Basin Pack, part number AMS2497 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Chest Breast Drape, part number AMS5853 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 (1344), part number AMS6561 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS479... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Opgrande Hand Pack, part number AMS4767 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Ocular Plastic Pack, part number AMS3868(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Lap Pack, part number AMS4801 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 GYN Pack, part number AMS4013(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Total Knee Pack (15710), part number AMS6563 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Liposuction Pack, part number AMS3323(B Liposuction Pack, part number AMS568... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 General Plastics Pack, part number 008617-1 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Augmentation Pack, part number AMS6370 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.