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.

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Date	Product	Reason	Class	Firm
Nov 20, 2014	ACCU-CHEK Tender I 17/80 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 13/110 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.
Sep 25, 2014	ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo ...	The insulin pump may lose time and date settings during a power interruption (such as a battery c...	Class II	Roche Diagnostics Operations, Inc.
Sep 12, 2014	Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roch...	The default references for normal values are inconsistent between cobas b 221 and other blood gas...	Class III	Roche Diagnostics Operations, Inc.
Jul 31, 2014	Roche cobas IT 1000 Product Usage: Intended Use: An electronic device int...	Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives ...	Class II	Roche Diagnostics Operations, Inc.
May 21, 2014	cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filt...	Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ...	Class II	Roche Diagnostics Operations, Inc.
May 21, 2014	cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filt...	Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ...	Class II	Roche Diagnostics Operations, Inc.
May 21, 2014	Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software...	Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ...	Class II	Roche Diagnostics Operations, Inc.
Apr 14, 2014	ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Mete...	Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneous...	Class II	Roche Diagnostics Operations, Inc.
Mar 13, 2014	Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a c...	The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas ...	Class II	Roche Diagnostics Operations, Inc.
Feb 28, 2014	Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Cata...	Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially ...	Class II	Roche Diagnostics Operations, Inc.
Nov 25, 2013	MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstatio...	This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrume...	Class II	Roche Diagnostics Operations, Inc.
Oct 25, 2013	ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva C...	There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when th...	Class II	Roche Diagnostics Operations, Inc.
Sep 16, 2013	COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers ...	Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service A...	Class II	Roche Diagnostics Operations, Inc.
Aug 19, 2013	ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction wit...	Internal Roche inspections have revealed that after the lancet is used for a finger stick, the ne...	Class II	Roche Diagnostics Operations, Inc.
May 16, 2013	CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by p...	Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X...	Class II	Roche Diagnostics Operations, Inc.
May 16, 2013	CoaguChek XS Plus System The CoaguChek XS Plus system for use by professio...	Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X...	Class II	Roche Diagnostics Operations, Inc.
May 16, 2013	CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the ...	Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X...	Class II	Roche Diagnostics Operations, Inc.
May 16, 2013	CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro mete...	Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X...	Class II	Roche Diagnostics Operations, Inc.
Apr 25, 2013	B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoass...	Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interferen...	Class II	Roche Diagnostics Operations, Inc.
Apr 4, 2013	Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, im...	When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain ass...	Class II	Roche Diagnostics Operations, Inc.
Mar 6, 2013	ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Use...	Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode...	Class II	Roche Diagnostics Operations, Inc.
Mar 6, 2013	CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used...	Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode...	Class II	Roche Diagnostics Operations, Inc.
Mar 1, 2013	Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog n...	Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir...	Class II	Roche Diagnostics Operations, Inc.
Nov 19, 2012	Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic ana...	A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener ...	Class III	Roche Diagnostics Operations, Inc.
Nov 14, 2012	Cobas b 123 POC system cobas b 123 POC system is fully automated POC syste...	It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 214...	Class II	Roche Diagnostics Operations, Inc.
Nov 1, 2012	Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. T...	On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the ...	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.