Browse Device Recalls

315 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 315 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 315 FDA device recalls.

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DateProductReasonClassFirm
Aug 16, 2024 Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Sa... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Sa... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health S... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Sal... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Dec 22, 2023 Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Apr 24, 2023 Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover ... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Windstone Medical Packaging, Inc.
Apr 24, 2023 Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Co... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Windstone Medical Packaging, Inc.
Apr 24, 2023 Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Li... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Windstone Medical Packaging, Inc.
Nov 1, 2022 Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product D... Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalle... Class II Windstone Medical Packaging, Inc.
Mar 21, 2022 Prevantics swabs and/or swabsticks contained inside the following Aligned Med... Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional D... Class II Windstone Medical Packaging, Inc.
Aug 19, 2021 Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 888157012... Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits.... Class I Windstone Medical Packaging, Inc.
Apr 8, 2021 Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR ... Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Class II Windstone Medical Packaging, Inc.
Apr 8, 2021 Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bo... Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Class II Windstone Medical Packaging, Inc.
Oct 24, 2017 AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO. Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were sub... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Ortho Basic Pack, part number AMS6459 Product packaged in a convenient ma... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Eye Pack, part numbers WAL1085(B and WAL1085(C\ Product packaged in a conven... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a con... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Minor Operation Kit, part number AMS1530 Product packaged in a convenient ma... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a co... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 ENT Pack, part number AMS2727 Product packaged in a convenient manner for us... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner fo... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Setup Pack, part number AMS3112(A Product packaged in a convenient manner fo... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Vitrectomy Pack, part number AMS4952 Product packaged in a convenient mann... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a c... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient mann... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 PRK Tray, part number DDS1044 Product packaged in a convenient manner for ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient ... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Mar 16, 2017 Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, a... AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, pa... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Stem Pack, part number AMS5166 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Hernia Pack, part number AMS3859 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Bayview Abdominoplasty Pack, part number 009079-1 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Lower Extremity Pack, part number AMS4669 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Lap Gallbladder Pack, part number AMS3707 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Facial Plastic Pack, part number AMS3327(C The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Universal Pack, part number AMS2036 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Morris Lap Pack, part number PSS3199(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Angio Pack, part number AMS6711 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Brow Pack, part number PSS1785(C The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Extremity Pack-N Brunswick, part number PSS1866(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Plastic General Pack, part number AMS4215 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, 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.