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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

5,424 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,424 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 5,424 FDA device recalls.

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DateProductReasonClassFirm
Jul 31, 2017 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Cle... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClav... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Port... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotat... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clav... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced P... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clav... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotat... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, ... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way St... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Rem... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Conn... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-W... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿,... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 31, 2017 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Sto... Some devices were labeled as Does not contain DEHP even though the product may contain small am... Class II ICU Medical, Inc.
Jul 28, 2017 Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (3... Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophi... Class II C.R. Bard, Inc.
Jul 27, 2017 A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be u... Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3... Class II Zimmer Surgical Inc
Jul 27, 2017 A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, In... Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3... Class II Zimmer Surgical Inc
Jul 24, 2017 Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS111111102... Implant kit mislabeled Class II ConforMIS, Inc.
Jul 21, 2017 FUJINON ED-530XT. This device is intended for the visualization of the duo... An update to the design and labeling was implemented to help reduce patient risk associated with ... Class II Fujifilm Medical Systems U.S.A., Inc.
Jul 21, 2017 SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. Th... The plates do not have wells punched for the controls in the patient 1 area. Class II Helena Laboratories, Corp.
Jul 20, 2017 Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The fi... Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely ... Class II Beckman Coulter Inc.
Jul 12, 2017 CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S... Class II DePuy Orthopaedics, Inc.
Jul 12, 2017 CORAIL HIGH OFFSET STEM Collarless SIZE 14 Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S... Class II DePuy Orthopaedics, Inc.
Jul 7, 2017 Mac Pin Non-Cannulated Screw, 6.5 x 60mm Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, t... Class II Amendia, Inc
Jul 5, 2017 LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 M... Teleflex Medical is recalling the affected product because there may be missing or incomplete inf... Class II Teleflex Medical
Jul 3, 2017 Beijing Syntech Laser Trixel C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser Nice Station Light Based Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser UL Station surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser Diode Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser UL C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jun 30, 2017 731 Series Ventilators running software version 05.20.00 The devices in t... A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user... Class II ZOLL Medical Corporation
Jun 29, 2017 Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on t... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, 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.