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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

3,096 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,096 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 3,096 FDA device recalls.

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DateProductReasonClassFirm
Oct 22, 2018 Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm L... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 c... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item N... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm ... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 c... Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chev... Class II Zimmer Biomet, Inc.
Oct 17, 2018 Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-... A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... Class II Leoni Fiber Optics GmbH
Oct 17, 2018 Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-... A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... Class II Leoni Fiber Optics GmbH
Oct 17, 2018 Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-... A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... Class II Leoni Fiber Optics GmbH
Oct 17, 2018 Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve S... A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... Class II Leoni Fiber Optics GmbH
Oct 17, 2018 Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Ste... A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack... Class II Leoni Fiber Optics GmbH
Oct 16, 2018 (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, R... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/b... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx.... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, N... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm n... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-steri... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Conver... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Sto... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straig... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 12, 2018 Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 This recall has been initiated in response to a seal defect found in certain sterile barrier pouc... Class II Atrium Medical Corporation
Oct 1, 2018 LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile ... Pouches from this lot are not sealed compromising the sterility Class II LeMaitre Vascular, Inc.
Sep 14, 2018 Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek ... The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... Class II Ecolab Inc
Sep 14, 2018 Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek ... The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... Class II Ecolab Inc
Sep 14, 2018 Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx S... The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... Class II Ecolab Inc
Sep 14, 2018 Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / ... The pouches of certain lots of product may have wrinkles along the pouch seal that could result i... Class II Ecolab Inc
Aug 30, 2018 Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The ... The product was shipped after its expiry date due to a system error. The product lidstock identi... Class II Arrow International Inc
Aug 24, 2018 Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 24, 2018 Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141 Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 24, 2018 Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061 Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 24, 2018 Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vi... Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class II Life Technologies, Corp.
Aug 13, 2018 CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-1... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) P... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 12... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Numb... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Produ... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Num... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UN... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, 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.