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Browse Device Recalls

916 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 916 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 916 FDA device recalls in MO.

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DateProductReasonClassFirm
Oct 20, 2022 ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 83009900... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery conven... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenienc... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenienc... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery conven... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 12, 2022 BASIN SET, MEBS42K, general surgical kit Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the... Class II American Contract Systems, Inc.
Jun 16, 2022 Various PICC Line, Central Line Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Laparoscopy Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various hysterectomy, vaginal packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Cysto Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Angiography/Cath Lab packs/trays Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various ENT Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Pacemaker Packs, Cardio Thoracic Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various neurology packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various eye packs, cataract packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various ob/gyn packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Port Insertion Packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 D&C pack Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various convenience packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various convenience packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various C-section packs Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Breast Abdominoplasty Pack Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 16, 2022 Various Angiography packs/trays Product was exposed to multiple sterilization cycles without validation for multiple exposures. Class II American Contract Systems, Inc.
Jun 3, 2022 Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother. Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. Class II ROi CPS LLC
Jun 3, 2022 Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part ... Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. Class II ROi CPS LLC
May 20, 2022 regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile. A nonsterile component was packaged in a sterile convenience kit. Class II ROi CPS LLC
May 3, 2022 regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003 Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled. Class II ROi CPS LLC
May 3, 2022 Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. ... Potential for the tip of the electrode to detach during use. Class II ROi CPS LLC
May 2, 2022 Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID ... Affected products were assembled off-site by individuals who may not have been properly trained. Class I American Contract Systems, Inc.
May 2, 2022 Clean Catch Urine Kit NS 178489, AHMU58A Affected products were assembled off-site by individuals who may not have been properly trained. Class I American Contract Systems, Inc.
Apr 5, 2022 The following first aid kits and cabinets containing components Medi-First XS... First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at... Class II Certified Safety Mfg Inc
Mar 22, 2022 ACS IR - Angio Pack Product was sterilized with a higher than specification EO concentration. Class II American Contract Systems, Inc.
Mar 22, 2022 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack Product was sterilized with a higher than specification EO concentration. Class II American Contract Systems, Inc.
Mar 22, 2022 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray Product was sterilized with a higher than specification EO concentration. Class II American Contract Systems, Inc.
Mar 22, 2022 ACS Lap Chole Pack Product was sterilized with a higher than specification EO concentration. Class II American Contract Systems, Inc.
Mar 22, 2022 ACS Cath Lab Pack Product was sterilized with a higher than specification EO concentration. Class II American Contract Systems, Inc.
Mar 21, 2022 Regard brand CABG Pack A and B - Spartanburg Kits were packed into shipping boxes incorrectly. Class II ROi CPS LLC
Mar 18, 2022 Convenience kits containing regard IV Start Kits: (1) regard Clinical Pack... A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ... Class II ROi CPS LLC
Mar 18, 2022 Convenience kits containing regard IV Start Kits: regard Clinical Packaging ... A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ... Class II ROi CPS LLC
Mar 18, 2022 Convenience kits containing regard IV Start Kits: (1) regard Clinical Pack... A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ... Class II ROi CPS LLC
Feb 28, 2022 Regard IV Start Kit for preparing and/or dressing a peripheral vein intraveno... A kit component, the PDI Prevantics Swab, was recalled. Class II Resource Optimization & Innovation LLC
Feb 24, 2022 Regard Custom Procedure Kits containing BD Luer Lok Access Devices Recalled devices were packaged in convenience kits. Class III ROi CPS LLC
Jan 13, 2022 Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile Products are mislabeled with the incorrect product identification on individual kit labeling. Class II ROi CPS LLC
Dec 29, 2021 YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR ... The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Ind... Class II Young Dental Mfg Co I LLC
Dec 20, 2021 API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualita... Risk of misidentification or delayed results with the absence of identification due to thermoform... Class II Biomerieux Inc
Nov 30, 2021 Regard, T AND A - Rogers, sterilized convenience kits Kits lacks rubber latex warning label. Class II ROi CPS LLC
Nov 9, 2021 RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in... There is an error in the new version of the package insert. The Reading Table lists the incorrec... Class II Biomerieux 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.