Browse Device Recalls

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

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DateProductReasonClassFirm
Nov 9, 2022 VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3... When selecting the site fraction group for treatment, the User may select the wrong site for trea... Class II Siemens Medical Solutions USA, Inc
Nov 9, 2022 PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 8, 2022 Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. Class II Corin Ltd
Nov 8, 2022 FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... Class II Foundation Medicine, Inc.
Nov 8, 2022 Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. Class II Corin Ltd
Nov 8, 2022 FoundationOne CDx (F1CDx), RAL-0003 version 31.0 Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... Class II Foundation Medicine, Inc.
Nov 8, 2022 InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, ... Diabetes management app may crash immediately upon opening, while using the app and/or while app ... Class II Companion Medical, Inc.
Nov 8, 2022 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Impla... No expiration dates printed on the packaging Class II ENDO Pharmaceuticals Solutions, Inc.
Nov 7, 2022 Cordis Angiographic Catheter Extensions. Used to transport fluid from th... There is a potential for separation at the male connector. Class II Cordis US Corp
Nov 7, 2022 Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Pr... The power backup battery, under certain conditions, may exhibit reduced battery run-time while in... Class II Getinge Usa Sales Inc
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Sie... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... Class II Siemens Healthcare Diagnostics, Inc.
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. ... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... Class II Siemens Healthcare Diagnostics, Inc.
Nov 4, 2022 Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter i... XXX Class II Medical Action Industries, Inc. 306
Nov 4, 2022 IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, excep... Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... Class II Siemens Healthcare Diagnostics, Inc.
Nov 4, 2022 HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be c... Class II Olympus Corporation of the Americas
Nov 3, 2022 DeRoyal BIOPSY PACK, REF 89-9270.04 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal FOOT PACK, REF 89-9252.06 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal LAMINECTOMY PACK, REF 89-10209.02 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal PODIATRY PACK, REF 89-8359.10 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal PACEMAKER ICD PACK, REF 89-10216.06 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal NEURO PACK, REF 89-10171.03 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BIOPSY PACK, REF 89-9614.07 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BIOPSY PACK, REF 89-9739.06 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal BASIC EYE PACK, REF 89-9233.08 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal MAJOR ORTHO PACK, REF 89-9250.07 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal EYE PACK, REF 89-8756.03 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal KIT HEART B PACK, REF 89-9042.08 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal EYE TRAY PGYBK, REF 89-7978.02 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal NEURO PACK, REF 89-10171.05 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal TOTAL HIP KIT, REF 89-9498.10 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal TOTAL HIP PACK, REF 89-9301.07 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CATARACT PACK, REF 89-7135.10 DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CUSTOM NEURO PACK, REF 89-8392.10 XXX Class II DeRoyal Industries 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.