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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

3,528 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,528 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 3,528 FDA device recalls — Class I.

Clear
DateProductReasonClassFirm
Dec 15, 2020 Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperf... The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... Class I Penumbra Inc.
Dec 15, 2020 Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Devic... The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... Class I Penumbra Inc.
Dec 15, 2020 Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing RE... The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun... Class I Penumbra Inc.
Dec 2, 2020 EMBLEM S-ICD Model A209 Electrical overstress may lead to device malfunction. Class I Boston Scientific Corporation
Dec 2, 2020 EMBLEM MRI S-ICD Model A219 Electrical overstress may lead to device malfunction. Class I Boston Scientific Corporation
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-R... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G4... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-R... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G4... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 24, 2020 Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G5... There is an increased likelihood of the introducer sheath separating at the proximal bond site. ... Class I Cook Inc.
Nov 19, 2020 Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, ... Pumps manufactured with impellers from a subset of lots from a single supplier are failing to ini... Class I Heartware, Inc.
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 17, 2020 Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ... Failure to execute the visual inspection correctly prior to locking the valve during the deployme... Class I Boston Scientific Corporation
Nov 13, 2020 EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable car... There is potential for fractures which results in the inability to delivery therapy. Class I Boston Scientific Corporation
Oct 22, 2020 Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved... Affected product was dropped during manufacturing, which may result in a bent wire guide and/or t... Class I Cook Inc.
Sep 22, 2020 ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038... When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated se... Class I Flexicare Medical Ltd.
Sep 21, 2020 Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM... Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever ... Class I Stryker Neurovascular
Aug 31, 2020 Langston Dual Lumen Catheter. The inner lumen of the Langston catheter may separate from the hub during pressure injection. Class I Vascular Solutions, Inc.
Aug 31, 2020 Langston Dual Lumen Catheter The inner lumen of the Langston catheter may separate from the hub during pressure injection. Class I Vascular Solutions, Inc.
Aug 31, 2020 Langston Dual Lumen Catheter. The inner lumen of the Langston catheter may separate from the hub during pressure injection. Class I Vascular Solutions, Inc.
Aug 31, 2020 Langston Dual Lumen Catheter. The inner lumen of the Langston catheter may separate from the hub during pressure injection. Class I Vascular Solutions, Inc.
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, ... Subsequent failure of catheters in the field and failed quality testing Class I Medtronic Vascular
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Singl... Subsequent failure of catheters in the field and failed quality testing Class I Medtronic Vascular
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Singl... Subsequent failure of catheters in the field and failed quality testing Class I Medtronic Vascular
Aug 4, 2020 BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assemb... Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress p... Class I CareFusion 303, Inc.
Aug 4, 2020 Alaris System PC Unit Model 8015 The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre... Class I CareFusion 303, Inc.
Aug 4, 2020 BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alari... The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in... Class I CareFusion 303, Inc.
Aug 4, 2020 PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT ... The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre... Class I CareFusion 303, Inc.
Jul 31, 2020 PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, ... MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra... Class I MicroPort Orthopedics Inc.
Jul 31, 2020 PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01... MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra... Class I MicroPort Orthopedics 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.