Browse Device Recalls

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

Clear
DateProductReasonClassFirm
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 15, 2017 STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... Intuitive Surgical has become aware and further investigation has determined that misinterpretati... Class II Intuitive Surgical, Inc.
Mar 13, 2017 Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Proble... The Pause function on central monitors will not automatically resume when connected to a Life Sco... Class II Nihon Kohden America Inc
Mar 10, 2017 Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibratio... Class II Beckman Coulter Inc.
Mar 7, 2017 Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2... Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... Class II Beckman Coulter Inc.
Mar 7, 2017 UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 P... Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... Class II Beckman Coulter Inc.
Mar 7, 2017 Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product... Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... Class II Beckman Coulter Inc.
Mar 3, 2017 ImplantDirect, Dental implants intended for use in partially and fully edentu... The main vial label lists the incorrect part number, but the cap label is correct. Class II Implant Direct Sybron Manufacturing, LLC
Feb 27, 2017 Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Nu... Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endura... Class II Medtronic Vascular, Inc.
Feb 22, 2017 The Medtronic StrataMR adjustable valves and shunts are designed to provide c... Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the Strata... Class I Medtronic Neurosurgery
Feb 20, 2017 MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGu... CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.... Class II CareFusion 303, Inc.
Feb 20, 2017 MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. M... CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter beca... Class II CareFusion 303, Inc.
Feb 15, 2017 Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantit... After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the comp... Class II Focus Diagnostics Inc
Feb 15, 2017 Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting ... After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the comp... Class II Focus Diagnostics Inc
Feb 13, 2017 Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack I... Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack... Class II Beckman Coulter Inc.
Feb 13, 2017 CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN R... The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may pre... Class II Abbott Laboratories
Feb 10, 2017 StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI... Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit diff... Class II Abbott Vascular
Feb 8, 2017 AIA-PACK TgAb CONTROL SET The label contains two different methodologies. Quality Control values for non-FDA approved metho... Class III Tosoh Bioscience, Inc.
Feb 8, 2017 AIA-PACK TPOAb CONTROL SET The label contains two different methodologies. Quality Control values for non-FDA approved metho... Class III Tosoh Bioscience, Inc.
Feb 7, 2017 Raindrop Near Vision Inlay, Model# RD1-1 ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to ... Class II Revision Optics Inc
Feb 1, 2017 Final Fit Software Version 1.11 and 1.12; PC Based software installed outsi... During treatment planning, the procedure was programmed with an unintended (wrong) correction. Class II Nidek Inc
Feb 1, 2017 Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ven... The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor ... Class II Respironics California Inc
Feb 1, 2017 Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System ... It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Trackin... Class II Toshiba American Medical Systems Inc
Jan 31, 2017 MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel... Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro... Class II Medtronic Inc.
Jan 31, 2017 AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 ... Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot swi... Class II Boston Scientific Corporation
Jan 30, 2017 iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-771... The probe misalignment or bending has the potential to lead to delay in reporting results or inco... Class II Beckman Coulter Inc.
Jan 26, 2017 The ABL800 Model#:All Reports that the sample type "cord blood" has been changed into the two sample types "cord blood ... Class II Radiometer America Inc
Jan 26, 2017 ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures p... Reports that the sample type "cord blood" has been changed into the two sample types "cord blood ... Class II Radiometer America Inc
Jan 25, 2017 Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packa... Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incor... Class II Quidel Corporation
Jan 23, 2017 XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targete... When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wir... Class II Strata Skin Sciences, Inc.
Jan 17, 2017 Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Perito... Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between Fe... Class II Medtronic Neurosurgery
Jan 9, 2017 STERRAD NX Sterilization System, Product Code: 10033, 10033-002 Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following ... Class II Advanced Sterilization Products
Jan 6, 2017 C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; ... The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the co... Class II C2 Therapeutics, Inc.
Jan 4, 2017 AFX Endovascular AAA System Item Number Item Description F0070305 ... Endologix updated information on the rates of Type III endoleaks and suggestions for patient surv... Class II Endologix
Jan 4, 2017 AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA... Endologix updated information on the rates of Type III endoleaks and suggestions for patient surv... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcate... Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA Sy... Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type IIIA Endologix initiated a correction by updating reports for the cumulative clinical data and informa... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX En... Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcat... Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... Class II Endologix
Dec 27, 2016 AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcate... Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas... Class II Endologix
Dec 21, 2016 AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1... Beckman Coulter initiated a design change to update the Automate PC image to accommodate the oper... Class III Beckman Coulter Inc.
Dec 19, 2016 UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465,... Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... Class II Beckman Coulter 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.