Browse Device Recalls

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

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DateProductReasonClassFirm
Dec 19, 2014 Quickie Q7 Adult Rigid Wheelchair Model EIR4. There is the potential for the height adjustable handle to dislodge due to failing locking mechan... Class II Sunrise Medical (US) LLC
Dec 18, 2014 Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software ver... Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jud... Class II St Jude Medical Cardiac Rhythm Management Division
Dec 18, 2014 Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This de... Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (a... Class II Spinal Elements, Inc
Dec 15, 2014 Beckman Coulter, Lipase Assay, Catalog No. OSR6X30 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 15, 2014 Beckman Coulter, Lactate Assay, Catalog No. OSR6X93 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 15, 2014 Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 15, 2014 Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16 N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... Class II Beckman Coulter Inc.
Dec 12, 2014 MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product U... Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over t... Class II Biocare Medical Llc
Dec 8, 2014 iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro... Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive l... Class II Beckman Coulter Inc.
Dec 5, 2014 INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 01000... In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... Class I Alere San Diego, Inc.
Dec 5, 2014 INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing Sys... In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... Class I Alere San Diego, Inc.
Dec 5, 2014 Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional ... In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... Class I Alere San Diego, Inc.
Dec 5, 2014 IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgic... Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vi... Class II Intuitive Surgical, Inc.
Dec 4, 2014 Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joi... The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to... Class II Hansen Medical Inc
Dec 3, 2014 RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizont... Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifu... Class II Iris Diagnostics
Nov 21, 2014 Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescen... The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging... Class II Intuitive Surgical, Inc.
Nov 21, 2014 Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescen... The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging... Class II Intuitive Surgical, Inc.
Nov 20, 2014 IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64... Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a ... Class II Boston Scientific Corp
Nov 19, 2014 Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... Class I Boston Scientific Corporation
Nov 19, 2014 Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower... HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 ... Class II Horiba Instruments Inc
Nov 19, 2014 Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... Class I Boston Scientific Corporation
Nov 19, 2014 Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... Class I Boston Scientific Corporation
Nov 17, 2014 PKG, PENNINGTON FORCEPS, P/N 0250080242. Laparoscopic Manual Instruments ar... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM PEEK HANDLE, 45CM, P/N 0250181164 Laparoscopic Manual Instruments a... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM X 33CM INSERT, JOHANN FORCEPS, P/N 0Laparoscopic Manual Instruments ... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopi... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. Laparoscopic Manual Instrume... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM X 45CM INSERT, ALLIS FORCEPS, DOUBLE ROW TEETH, P/N 0250080754 Lapa... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 29CM, P/N 0250282052 Laparoscopic Manu... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 Laparoscopic Manual In... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029. Laparoscopic Manual Instrume... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080281. Laparoscopic... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, ASSY, 3.5MM PYRAMIDAL TROCAR, LONG P/N 0250080730 Laparoscopic Manual ... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. Laparoscopic Manual Instrum... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 Laparoscopic Manual Instr... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Ins... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MINI METZENBAUM SCISSORS, CURVED LONG, P/N 0250080266. Laparoscopic Ma... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM, P/N 0250080580 Laparoscopic Ma... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 Lap... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Man... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, SPRING HANDLE, P/N 0250080237. Laparoscopic Manual Instruments are int... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 Laparoscopic ... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, CLAW FORCEPS, P/N 0250080244. Laparoscopic Manual Instruments are inte... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MICRO SCISSORS, CURVED, P/N 0250080270. Laparoscopic Manual Instrument... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. Laparoscopic Manual Instrume... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 33CM DORSEY GRASPER FORCEPS, P/N 0250080319. Laparoscopic Manual Instruments... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 29CM, P/N 0250282053 Laparosc... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, DEBANEY FORCEPS, P/N 0250080314. Laparoscopic Manual Instruments are in... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy
Nov 17, 2014 PKG, 3MM INSERT, PERITONEAL SCISSORS, 29CM, P/N 0250282048 Laparoscopic Manu... The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... Class II Stryker Endoscopy

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.