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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

Consumer Safety

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

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
Feb 8, 2019 Terumo Needle, 23G x 1", Product Code NN2325R There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Feb 8, 2019 Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 There is a potential for a loss of package integrity that may compromise the sterility of the pro... Class II Terumo Medical Corporation
Feb 4, 2019 Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per bo... Potential compromise of product sterility after routine monitoring for Endotoxins showed an out o... Class II CP Medical Inc
Jan 28, 2019 Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: ... The product may not have met sterility requirements . Use of a non-sterile device on a patient m... Class II Applied Medical Resources Corp
Jan 17, 2019 Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expirati... The product may not meet sterility requirements. Product labeled as sterile, however all units do... Class II DJO, LLC
Jan 16, 2019 daVinci Harmonic ACE Curved Shears During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Ha... Class II Intuitive Surgical, Inc.
Dec 5, 2018 Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 The sterility may be compromised due to a potential breach in the packaging, even though it may a... Class III Medela Inc
Nov 27, 2018 Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed wi... Potential compromise of product sterility due to breach of sterile barrier. Class II Medical Action Industries Inc
Nov 16, 2018 Presource Kit Total Joint Pack containing a double-wrapped basin component. ... The double wrapping of this custom kit basin set is not supported by the current sterility assura... Class II Cardinal Health Inc.
Nov 12, 2018 Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with... Insufficient seal on the sterile barrier of the device, compromising the sterility of the device Class II Bracco Injeneering S.A.
Oct 22, 2018 Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Di... 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 Natural Nail¿ System - Tear Drop Guide Wire, 3.0 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 Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet T... 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 Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Le... 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 Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Num... 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 Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet T... 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 - Smooth, 2.4 mm Diam... 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 Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Le... 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 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.

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.