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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

3,096 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,096 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 3,096 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for u... Sterility of device may be compromised due to lack of packaging integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 8, 2013 SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mes... Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and... Class II Allergen Medical
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capac... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removab... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capaci... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capac... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double ... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removabl... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 18, 2012 Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capaci... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health
Dec 14, 2012 Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm... Some of the individual extension set packages were improperly sealed, compromising the sterility ... Class II Baxter Healthcare Corp.
Nov 21, 2012 Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tra... Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the se... Class II Merit Medical Systems, Inc.
Nov 19, 2012 Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioA... Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that c... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Nov 5, 2012 MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardia... The seal between the white polyethylene and the clear plastic may be missing on the Hand Controll... Class II Medrad Inc
Oct 29, 2012 Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Devi... Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achiev... Class II Cordis Corporation
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Par... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part#... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, P... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Par... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp

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.