Browse Device Recalls

1,694 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,694 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 1,694 FDA device recalls.

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Date	Product	Reason	Class	Firm
Apr 13, 2017	Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE ...	Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles i...	Class II	Medtronic Sofamor Danek USA Inc
Apr 12, 2017	Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Qu...	An unexpected transient mode switch behavior was detected by Medtronic during systems testing tha...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
Mar 30, 2017	Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: T...	Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" H...	Class I	Newport Medical Instruments Inc
Mar 17, 2017	DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead ...	Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which c...	Class II	Medtronic Neuromodulation
Mar 16, 2017	Ortho Basic Pack, part number AMS6459 Product packaged in a convenient ma...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a conven...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a con...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Minor Operation Kit, part number AMS1530 Product packaged in a convenient ma...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a ...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a ...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a co...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	ENT Pack, part number AMS2727 Product packaged in a convenient manner for us...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner fo...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Setup Pack, part number AMS3112(A Product packaged in a convenient manner fo...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Vitrectomy Pack, part number AMS4952 Product packaged in a convenient mann...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a c...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient mann...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	PRK Tray, part number DDS1044 Product packaged in a convenient manner for ...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient ...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 16, 2017	Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, a...	AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo...	Class II	Windstone Medical Packaging, Inc.
Mar 10, 2017	HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Prod...	In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to th...	Class I	Heartware
Feb 27, 2017	Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Nu...	Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endura...	Class II	Medtronic Vascular, Inc.
Feb 22, 2017	The Medtronic StrataMR adjustable valves and shunts are designed to provide c...	Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the Strata...	Class I	Medtronic Neurosurgery
Feb 20, 2017	Poly Component Trial, MPCS, packaged in the following sizes and configuration...	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.	Class II	Medtronic Sofamor Danek USA Inc
Feb 20, 2017	Poly Component Trial, PS, packaged in the following sizes and configurations:...	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.	Class II	Medtronic Sofamor Danek USA Inc
Feb 20, 2017	Poly Component Trial, CR, packaged in the following sizes and configurations:...	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.	Class II	Medtronic Sofamor Danek USA Inc
Feb 20, 2017	Poly Component Trial, UCCS, packaged in the following sizes and configuration...	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.	Class II	Medtronic Sofamor Danek USA Inc
Feb 9, 2017	SynchroMed II implantable drug infusion pump, Model 8637-40,	Medtronic received a complaint that there was an error code displayed on the programmer when the...	Class II	Medtronic Neuromodulation
Feb 8, 2017	BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01	Handle may break during use.	Class II	Medtronic
Feb 8, 2017	SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01	Handle may break during use.	Class II	Medtronic
Feb 8, 2017	SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01	Handle may break during use.	Class II	Medtronic
Feb 8, 2017	SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01	Handle may break during use.	Class II	Medtronic
Feb 8, 2017	BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01	Handle may break during use.	Class II	Medtronic
Jan 31, 2017	MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel...	Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro...	Class II	Medtronic Inc.
Jan 26, 2017	Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Ste...	Customer reports of the device handset continuing to operate after release of the activation button.	Class II	COVIDIEN MEDTRONIC
Jan 17, 2017	Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Perito...	Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between Fe...	Class II	Medtronic Neurosurgery
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.

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.