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Browse Device Recalls

16 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 16 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 16 FDA device recalls.

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DateProductReasonClassFirm
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular Tampons, 34 Count Potential for tampon to come apart upon removal. Class II Kimberly-Clark Corporation
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack Potential for tampon to come apart upon removal. Class II Kimberly-Clark Corporation
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular Tampons, 18 Count Potential for tampon to come apart upon removal. Class II Kimberly-Clark Corporation
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular Tampons, 3 Count Potential for tampon to come apart upon removal. Class II Kimberly-Clark Corporation
Oct 29, 2013 Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Ac... Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated... Class II Kimberly-Clark Corporation
Oct 24, 2013 Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD L... Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer... Class II Kimberly-Clark Corporation
Mar 6, 2013 KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm)... Some individual container filter units might contain thin areas that may potentially compromise t... Class II Kimberly-Clark Corporation
Jul 5, 2012 ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a ste... Package seam of some units may not remain properly sealed to ensure the contents might not be ste... Class II Kimberly-Clark Corporation
Jul 5, 2012 MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product... Package seam of some units may not remain properly sealed to ensure the contents might not be ste... Class II Kimberly-Clark Corporation
Apr 27, 2012 Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly... A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to los... Class II Kimberly-Clark Corporation
Dec 31, 2010 ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Ki... The impacted product was not intended for commercial distribution to end users. Class III Kimberly-Clark Corporation
Sep 16, 2010 Kimberly-Clark Patient Warming System - Model 1000 Control Unit The produc... Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. Class II Kimberly-Clark Corporation
Jun 22, 2010 Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - P... The placement guidewire diameter is too large and does not pass-through the introducer needle dur... Class II Kimberly-Clark Corporation
Jun 22, 2010 Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG K... The placement guidewire diameter is too large and does not pass-through the introducer needle dur... Class II Kimberly-Clark Corporation
Sep 17, 2009 MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-L... Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough an... Class II Kimberly-Clark Corporation
Sep 17, 2009 MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, ... Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough an... Class II Kimberly-Clark Corporation

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.