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Browse Device Recalls

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

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DateProductReasonClassFirm
Jul 18, 2012 The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray S... 1. The current system design of software version 4.0.0xx379 does not prevent the system from scan... Class II Philips Medical Systems (Cleveland) Inc
Jul 18, 2012 Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per s... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers... Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related... Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jul 18, 2012 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angl... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 17, 2012 RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ... Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needl... Class II Stryker Instruments Div. of Stryker Corporation
Jul 17, 2012 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 17, 2012 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 17, 2012 RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable... Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needl... Class II Stryker Instruments Div. of Stryker Corporation
Jul 17, 2012 Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K408... Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) r... Class III Siemens Healthcare Diagnostics, Inc.
Jul 17, 2012 Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Hea... Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dime... Class II Siemens Healthcare Diagnostics, Inc.
Jul 17, 2012 Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Number... Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insert... Class II Conformis Inc
Jul 17, 2012 Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Num... Syphilis Assay Interference with HBsAg Assay Class II Siemens Healthcare Diagnostics, Inc
Jul 16, 2012 DataCara GM is an information management system that provides data management... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 The COBAS 8000 data manager modular analyzer series (all versions) is a is a... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extens... Stryker has become aware that insufficient taper torsional strength may result when a PAR extensi... Class II Stryker Howmedica Osteonics Corp.
Jul 16, 2012 The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully autom... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for t... One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint ... Class II Encore Medical, Lp
Jul 16, 2012 Data Station AMPLILINK software is an instrument user interface/ data managem... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump gluco... Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad f... Class II Animas Corporation
Jul 16, 2012 DataInnovations (Instrument Manager) (version 8.04) interfaces middleware bet... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 The MagNA Pure LC (version 3.0) is a sample preparation instrument that can... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer wit... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation ins... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 16, 2012 DataCare POC  is an information management system that provides data managem... Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. Class II Roche Molecular Systems, Inc.
Jul 15, 2012 Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a ver... The firm voluntarily recalled the device after they discovered that the sterilization recommendat... Class II Lucero Medical LLC
Jul 14, 2012 The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanic... To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close ... Class II Steris Corporation
Jul 14, 2012 Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECU... Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months ... Class II Smith & Nephew, Inc. Endoscopy Division
Jul 14, 2012 Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Nu... Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months f... Class II Smith & Nephew, Inc. Endoscopy Division
Jul 13, 2012 GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. ... GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an ... Class II GE Healthcare, LLC
Jul 13, 2012 INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use ... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold ... Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to ... Class II Westone Laboratories, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 syngo Dynamics Version 9.5 If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time... Class II Siemens Medical Solutions, USA, Inc
Jul 13, 2012 Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch wi... The float valve in the burette sticks to the burette wall and does not open or close properly. Class II Hospira Inc.
Jul 13, 2012 The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-ste... Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NC... Class II Zimmer, Inc.
Jul 13, 2012 AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), auto... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutritio... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The inten... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; aut... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition com... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 12, 2012 GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a mul... GE Healthcare has recently become aware of a number of potential issues associated with the CARE... Class II GE Healthcare, LLC
Jul 12, 2012 Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Dru... Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that aft... Class II Alere San Diego, Inc.
Jul 12, 2012 Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree T... The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but ... Class II Aesculap Implant Systems LLC
Jul 11, 2012 Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporatio... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Sta... Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Class I Ventlab Corporation
Jul 11, 2012 Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dent... Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for... Class II Straumann USA, 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.