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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

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
Jul 31, 2017 134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gan... 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 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 24, 2017 Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... Class II Sorin Group Italia SRL - CRF
Jul 24, 2017 Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implan... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... Class II Sorin Group Italia SRL - CRF
Jul 24, 2017 Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... Class II Sorin Group Italia SRL - CRF
Jul 24, 2017 Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implant... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... Class II Sorin Group Italia SRL - CRF
Jul 24, 2017 Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implanta... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... Class II Sorin Group Italia SRL - CRF
Jul 24, 2017 Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implant... There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillator... Class II Sorin Group Italia SRL - CRF
Jul 17, 2017 CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... Class I Maquet Datascope Corp - Cardiac Assist Division
Jul 17, 2017 CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle ... False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... Class I Maquet Datascope Corp - Cardiac Assist Division
Jul 17, 2017 CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... Class I Maquet Datascope Corp - Cardiac Assist Division
Jul 13, 2017 Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumin... Stylette removal difficulties on the Euphora and Solarice products. Class II Medtronic Vascular Galway DBA Medtronic Ireland
Jul 13, 2017 Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Translumi... Stylette removal difficulties on the Euphora and Solarice products. Class II Medtronic Vascular Galway DBA Medtronic Ireland
Jul 13, 2017 Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W2... The firm received several customer complaints reporting some perioperative breakages of NE0411 No... Class II In2Bones, SAS
Jul 12, 2017 MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 ... Affected units may have a defective component that is intended to protect the internal circuitry ... Class I Philips North America, LLC
Jul 5, 2017 SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold... Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manu... Class II Centurion Medical Products Corporation
Jun 29, 2017 EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator... The device can deliver an atypical amount of energy due to memory corruption inside the device. Class II Boston Scientific Corporation
Jun 29, 2017 EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrill... The device can deliver an atypical amount of energy due to memory corruption inside the device. Class II Boston Scientific Corporation
Jun 29, 2017 SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is inten... The device can deliver an atypical amount of energy due to memory corruption inside the device. Class II Boston Scientific Corporation
Jun 26, 2017 Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Anal... Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... Class II Beckman Coulter Inc.
Jun 20, 2017 Intellicuff Standalone (PN 951001) Used to continuously measure and automa... Issue related to the performance of the motor in recalled product. During use, motor may cease to... Class II Hamilton Medical, Inc.
Jun 15, 2017 Plum 360 Infusion System Potential for the Connectivity Engine Module of the affected unit to disengage from the main chas... Class II ICU Medical Inc
Jun 15, 2017 Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES... The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1... Class II Custom Assemblies Inc
Jun 6, 2017 Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Ve... Real-time shelf life testing failed at 24 months Class II Microbiologics 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.