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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

3,629 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,629 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 3,629 FDA device recalls, Class I.

Clear
DateProductReasonClassFirm
Jul 15, 2013 Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Produc... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Nu... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These s... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 ... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Produ... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Prod... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 11, 2013 LPS Lower Extremity Dovetail Intercalary component. Intended for use in re... The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the fema... Class I DePuy Orthopaedics, Inc.
Jul 1, 2013 MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an opti... The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate v... Class I Iradimed Corporation
Jun 17, 2013 Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboG... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 A... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 Alb... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic bo... CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is ope... Class I CareFusion 303, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 17, 2013 AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 ... Blood blushing/leaking from the surface of the graft after implantation Class I LeMaitre Vascular, Inc.
Jun 13, 2013 Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is inten... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging sy... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intend... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Brivo NM615, is an all-purpose, single detector integrated nuclear imaging sy... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Cam... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Discovery NM 630, dual detector free-geometry integrated nuclear imaging syst... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 7, 2013 MedStream Programmable Infusion Pump- Implantable for the intrathecal deliver... Miscalibrated Fill Level Sensor may affect dosing level Class I Codman & Shurtleff, Inc.
Jun 7, 2013 Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion set... Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMe... Class I Medtronic MiniMed
Jun 7, 2013 MedStream Programmable Infusion Pump , Implantable for the intrathecal delive... Miscalibrated Fill Level Sensor may affect dosing level Class I Codman & Shurtleff, Inc.
Jun 4, 2013 Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 1... Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue wit... Class I Respironics California Inc
Jun 3, 2013 Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segm... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: cat... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Cont... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... Medtronic is providing Healthcare Professionals with important safety information and patient man... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... Medtronic is providing Healthcare Professionals with important safety information and patient man... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm c... The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the po... Class I Medtronic Neuromodulation
Jun 3, 2013 Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... Class I Medtronic Neuromodulation
May 30, 2013 Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long... Stryker has received reports from customers indicating post-operative fracture of the pin that c... Class I Stryker Spine
May 13, 2013 Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 107984... Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports... Class I Endologix Inc
May 10, 2013 Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps ... Class I Symbios Medical Products, LLC

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.