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Browse Device Recalls

86 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 86 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 86 FDA device recalls.

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DateProductReasonClassFirm
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
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
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 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
Nov 30, 2021 Regard, T AND A - Rogers, sterilized convenience kits Kits lacks rubber latex warning label. Class II ROi CPS LLC
Nov 4, 2021 regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn... The kit contains a non-sterile needle. Class II ROi CPS LLC
Aug 10, 2021 REGARD Stereotactic Tray Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... Class II ROi CPS LLC
Aug 10, 2021 REGARD Ultrasound Tray Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... Class II ROi CPS LLC
Aug 10, 2021 REGARD Core Biopsy Tray Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... Class II ROi CPS LLC
Aug 10, 2021 REGARD Newborn Tray Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... Class II ROi CPS LLC
Aug 10, 2021 REGARD Basic Cataract tray Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... Class II ROi CPS LLC
Aug 10, 2021 REGARD Ear Tray Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... Class II ROi CPS LLC
Aug 10, 2021 REGARD Vitrectomy Tray Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... Class II ROi CPS LLC
Jun 14, 2021 Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience k... Instructions for use updated to include the following cautionary statement for the heel warmer, "... Class II ROi CPS LLC
Jun 14, 2021 Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience k... Instructions for use updated to include the following cautionary statement for the heel warmer, "... Class II ROi CPS LLC
Jun 14, 2021 Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience k... Instructions for use updated to include the following cautionary statement for the heel warmer, "... Class II ROi CPS LLC
Mar 26, 2021 Regard Dressing Change Tray ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicato... Class II ROi CPS LLC
Mar 4, 2021 Regard, Item Number 830067009, custom cardiovascular procedure kit ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that ... Class II ROi CPS LLC
Nov 9, 2020 Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. ... Gauze sponges contained in custom kits may be flaking or fraying. Class II ROi CPS LLC
Oct 12, 2020 Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. ... Labeling error, incorrect expiration date. Class II ROi CPS LLC
May 19, 2020 Isolation Droplet Bundle Kit Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The ... Class II ROi CPS LLC
May 19, 2020 Respirator Crash Cart Kit Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The ... Class II ROi CPS LLC
Apr 20, 2020 Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy. Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD. Class II ROi CPS LLC
Jan 3, 2020 Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:... ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were s... Class II ROi CPS 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.