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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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Clear
DateProductReasonClassFirm
Mar 25, 2014 Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat... Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift i... Class II Siemens Healthcare Diagnostics, Inc
Mar 25, 2014 LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Rese... The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the ... Class II Hospira Inc.
Mar 25, 2014 AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for ort... The donor was hemodiluted. Class II AlloSource, Inc.
Mar 25, 2014 IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the managem... Potential for microbial contamination of the product. Class I Wellspring Pharmaceutical Corporation
Mar 24, 2014 AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5... There is a possibility the sterile packaging may fail before the expiration date specified on the... Class II Soma Access Systems LLC
Mar 24, 2014 Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number C... Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contai... Class II Arrow International Inc
Mar 21, 2014 Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump.... Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly... Class I Maquet Datascope Corp - Cardiac Assist Division
Mar 21, 2014 Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography... The rubber damper may degrade and break, causing loosening of the motor mounting plates, which co... Class II Siemens Medical Solutions USA, Inc
Mar 21, 2014 LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system... While projecting yellow lines it was notice that the yellow projection has the potential to split... Class II LAP of America Laser Applications, LLC
Mar 21, 2014 Amerigel Wound Dressing 55 gallons/drum Product may not have been manufactured pursuant to a validated process protocol and CGMP. Class II Kova Laboratories, Inc.
Mar 21, 2014 Amerigel Wound Dressing 1 oz. tube Product may not have been manufactured pursuant to a validated process protocol and CGMP. Class II Kova Laboratories, Inc.
Mar 20, 2014 Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrap... This lot did not go through the correct sterilization procedures. This product may potentially be... Class II Medline Industries Inc
Mar 20, 2014 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSyste... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type... Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in ... Class II Varian Medical Systems, Inc.
Mar 20, 2014 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuato... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C Sys... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile ... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain manage... The external power supply input is overheating at the connection to the freezer. Class II Global Cooling Inc
Mar 20, 2014 Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Sy... These lots may not recover within range when tested using certain commercially available controls. Class II Alere San Diego, Inc.
Mar 20, 2014 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile ... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C Sys... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 enGen (TM) Laboratory Automation System configured with Data Innovations, LLC... Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires fol... Class II Ortho-Clinical Diagnostics
Mar 20, 2014 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (1... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for d... Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system... Class II Solta Medical, Inc.
Mar 20, 2014 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuato... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intend... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) In... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 20, 2014 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case... The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidy... Class II Aspen Surgical Products, Inc.
Mar 19, 2014 Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/bo... Ultrasound needles may be defective and leak at the needle hub. Class II RM Temena GmbH
Mar 19, 2014 SmartSite Extension Set, Model No. 20029E, intravascular administration set. Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port. Class II CareFusion 303, Inc.
Mar 19, 2014 Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgica... The support arm attached with an adhesive to the body of the blade is detaching while attempting ... Class II Biorep Technologies
Mar 19, 2014 Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagn... A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when pat... Class II Siemens Healthcare Diagnostics, Inc.
Mar 19, 2014 DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment,... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needl... Ultrasound needles may be defective and leak at the needle hub. Class II RM Temena GmbH
Mar 19, 2014 Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatmen... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral st... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides com... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 18, 2014 ECATS E 850 Bariatric Bed, True Air Technologies, Inc. The firm is recalling the products due to lack of design controls, lack of a Device Master Record... Class II SCM True Air Technologies LLC
Mar 18, 2014 MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, ... The firm is recalling the products due to lack of design controls, lack of a Device Master Record... Class II SCM True Air Technologies LLC
Mar 18, 2014 JK Bariatric Beds, True Air Technologies, Inc. The firm is recalling the products due to lack of design controls, lack of a Device Master Record... Class II SCM True Air Technologies LLC
Mar 18, 2014 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is co... Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the li... Class II Stryker Instruments Div. of Stryker Corporation
Mar 18, 2014 Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by... Some of the power adapters outer casings may become loose and separate, resulting in a potential ... Class II Energizer Personal Care

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.