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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

3,096 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
Apr 18, 2019 Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Ma... Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 70105... Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 22701 Material: 701050790 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 18, 2019 Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01 Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock... Class II Maquet Cardiovascular, LLC
Apr 1, 2019 Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Nu... Pin hole package failures compromising sterility of product Class II Dornier Medtech America, Inc.
Mar 21, 2019 ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number:... Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... Class II Conmed Corporation
Mar 21, 2019 ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TR... Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... Class II Conmed Corporation
Mar 21, 2019 ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:... Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... Class II Conmed Corporation
Mar 21, 2019 ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog N... Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... Class II Conmed Corporation
Mar 21, 2019 ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: ... Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... Class II Conmed Corporation
Mar 21, 2019 ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: ... Voids in the seal or a partial seal results in an open channel and may compromise the sterility o... Class II Conmed Corporation
Mar 19, 2019 Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usa... During manufacture, packaging materials for a small portion of the lot may not have been properly... Class II Stryker Instruments Div. of Stryker Corporation
Mar 1, 2019 Laparotomy Sponge with the following product description and model numbers: ... Potential lack of sterility assurance Class II Medical Action Industries Inc
Feb 18, 2019 Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous... Breach in the sterile barrier pouch may compromise sterility of the device. Class II Avitus Orthopaedics, Inc.
Feb 18, 2019 Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellou... Breach in the sterile barrier pouch may compromise sterility of the device. Class II Avitus Orthopaedics, Inc.
Feb 15, 2019 Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 The product does not meet sterility requirements. Product labeled as sterile was distributed wit... Class II COVIDIEN LLC
Feb 8, 2019 Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 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, 22G x 3/4", Product Code 100279 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 Needle, 30G x 1/2", Product Code NN3013R 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 Needle, 18G x 1", Product Code NN1825R 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, 22G x 3/4", Product Code 100215 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, 22G x 1", Product Code 100211 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, 20G x 1", Product Code 100204 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 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.

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.