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Vehicle Safety

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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
Oct 21, 2013 COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT19... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 21, 2013 THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 18, 2013 PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw im... During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8... Class II SpineFrontier, Inc.
Oct 14, 2013 Philips Multi Diagnost Eleva with FlatDetector The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of t... Class II Philips Medical Systems, Inc.
Oct 14, 2013 Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Lib... Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result ... Class II Fresenius Medical Care Holdings, Inc.
Oct 14, 2013 Philips Multi Diagnost Eleva II The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of t... Class II Philips Medical Systems, Inc.
Oct 11, 2013 TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes ... Incorrect instructions for use (IFU). Class I Codman & Shurtleff, Inc.
Oct 11, 2013 TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube o... Incorrect instructions for use (IFU). Class I Codman & Shurtleff, Inc.
Oct 10, 2013 Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactat... Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell le... Class II Nova Biomedical Corporation
Oct 9, 2013 Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX NT2000iX software shipped with the international setting turned on. The international settings in... Class II Neurotherm, Inc.
Sep 27, 2013 OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-US... Alcohol Prep Pads contained within the kit are not properly labeled. Class II Insulet Corporation
Sep 27, 2013 OmniPod Insulin Management Product Demonstration Kit; Model Reference Number:... Alcohol Prep Pads contained within the kit are not properly labeled. Class II Insulet Corporation
Sep 24, 2013 Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81... Handles and heads may not be compatible. Class II SpineFrontier, Inc.
Sep 24, 2013 Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates tha... Handles and heads may not be compatible. Class II SpineFrontier, Inc.
Sep 24, 2013 Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-8... Handles and heads may not be compatible. Class II SpineFrontier, Inc.
Sep 12, 2013 Solea 1.0 Laser Surgical instrument for use in general and plastic surgery an... Specific error condition could lead to unintended laser emission during laser activation. Class II Convergent Dental
Sep 11, 2013 Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Ha... Potential for leur connector to leak or have cracks. Class II Harvest Technologies Corporation
Sep 11, 2013 PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect sp... Class II SpineFrontier, Inc.
Aug 29, 2013 Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9.... Updated Instructions for Use: Bloodline connections not tightened per instructions in the operato... Class II Fresenius Medical Care Holdings, Inc.
Aug 29, 2013 DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Pro... Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set ... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Aug 29, 2013 DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 ... Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set ... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Aug 29, 2013 Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended... Updated Instructions for Use: Bloodline connections not tightened per instructions in the operato... Class II Fresenius Medical Care Holdings, Inc.
Aug 29, 2013 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catal... Updated Instructions for Use: Bloodline connections not tightened per instructions in the operato... Class II Fresenius Medical Care Holdings, Inc.
Aug 28, 2013 S-LIFT Extension Shims Extension shims are manufactured from grade 5 titaniu... Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The f... Class II SpineFrontier, Inc.
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Pr... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Pr... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 ... PTH Calibrator packaged with only high calibrator. Class III Siemens Healthcare Diagnostics, Inc
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Prod... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Produc... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill P... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Produc... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 13, 2013 MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Me... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstrea... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstrea... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream progra... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programma... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Me... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 8, 2013 Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-... The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for si... Class II Philips Healthcare Inc.
Aug 6, 2013 TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black;... Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... Class II Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013 OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part ... Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... Class II Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013 TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (b... Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... Class II Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013 TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (bl... Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... Class II Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013 OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Par... Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... Class II Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013 OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 ... Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... Class II Smith & Nephew, Inc. Endoscopy Division
Aug 6, 2013 TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue;... Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... Class II Smith & Nephew, Inc. Endoscopy Division

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.