Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

127 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 127 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 127 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 15, 2016 cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a comput... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clini... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage:... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 RSD 800A Aliquoting System calculator/data processing module, for clinical u... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 612 Pre-Analytical Instrument calculator/data processing module, for... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 512 Pre-Analytical Instrument calculator/data processing module, for... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 501 Post-Analytical Unit calculator/data processing module, for clin... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 RSD 800 Sorting System calculator/data processing module, for clinical use ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: Th... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 VS II Aliquoter System calculator/data processing module, for clinical use ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 701 Post-Analytical Unit calculator/data processing module, for clin... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 471 centrifuge unit calculator/data processing module, for clinical ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Ch... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
May 26, 2016 ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Van... Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin as... Class II Roche Diagnostics Operations, Inc.
Mar 7, 2016 Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 ... Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not... Class II Roche Diagnostics Operations, Inc.
Mar 7, 2016 Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 ... Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not... Class II Roche Diagnostics Operations, Inc.
Feb 26, 2016 Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive... Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog n... Class II Roche Diagnostics Operations, Inc.
Feb 23, 2016 cobas p 512 pre-analytical system Pre-analytical sample handling that incl... Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not ... Class II Roche Diagnostics Operations, Inc.
Feb 11, 2016 Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Gluc... Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss... Class II Roche Diagnostics Operations, Inc.
Sep 22, 2015 Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that i... Possible for sample tubes in the loader to be opened and contaminate the system as well as adjace... Class II Roche Diagnostics Operations, Inc.
Sep 3, 2015 Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC s... under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack c... Class II Roche Diagnostics Operations, Inc.
Jul 14, 2015 cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas ... Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused b... Class II Roche Diagnostics Operations, Inc.
Jul 14, 2015 cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas ... Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused b... Class II Roche Diagnostics Operations, Inc.
Jun 24, 2015 S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood ... The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to ... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Triglycerides GPO. In vitro test for the quantitative determination of tri... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use ... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol tes... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) co... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholestero... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quant... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Triglycerides/Glycerol Blanked. In vitro test for the quantitative determi... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Uric Acid plus ver.2 In vitro test for the quantitative determination of u... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBA... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas ... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 HDL-Cholesterol gen.3. For the quantitative determination of high-density ... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
Mar 23, 2015 Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 1... Customers complained about under-recovery of non-Roche controls and discrepant low patient result... Class II Roche Diagnostics Operations, Inc.
Dec 18, 2014 Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positi... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the ... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infus... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusi... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the ... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infus... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the ... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for t... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusi... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, Inc.
Nov 20, 2014 ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the ... Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... Class II Roche Diagnostics Operations, 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.