Browse Device Recalls

1,708 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,708 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 1,708 FDA device recalls.

Clear
DateProductReasonClassFirm
May 17, 2017 KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R. The directional arrow at the proximal end of the instrument may not correctly align with the cut... Class II Medtronic Sofamor Danek USA Inc
May 10, 2017 Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Software issue related to the StealthStation S7 system and the Synergy Spine application Version ... Class II Medtronic Navigation, Inc.
May 8, 2017 MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755. Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 3, 2017 Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 ... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933;... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 USPACK-SUTURE KIT; Item Number: US1672 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211,... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 17... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 CUSTOM SUTURE PACK; Item Number: US1540 and US1614 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
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.

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.