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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 17, 2014 | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL R... | Product was improperly labeled leading to improper storage. | Class II | Mallinckrodt Manufacturing LLC |
| Oct 17, 2014 | Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapi... | An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Oct 17, 2014 | Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Mater... | An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2014 | UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instru... | Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the ... | Class II | Beckman Coulter Inc. |
| Oct 6, 2014 | Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Us... | Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the ... | Class II | Beckman Coulter Inc. |
| Oct 1, 2014 | Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spl... | Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was pr... | Class II | Zimmer Dental Inc |
| Oct 1, 2014 | Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TS... | Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was pr... | Class II | Zimmer Dental Inc |
| Sep 30, 2014 | Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-li... | Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on... | Class II | Masimo Corporation |
| Sep 23, 2014 | ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs ... | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... | Class II | Ameditech Inc |
| Sep 23, 2014 | ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint L... | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... | Class II | Ameditech Inc |
| Sep 23, 2014 | ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint La... | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... | Class II | Ameditech Inc |
| Sep 20, 2014 | Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. ... | TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be... | Class I | Trivascular, Inc |
| Sep 18, 2014 | EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: I... | Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discont... | Class II | Intuitive Surgical, Inc. |
| Sep 18, 2014 | Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product ... | A potential issue with false high values. | Class II | Biomerica |
| Sep 17, 2014 | EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical... | Intuitive Surgical is initiating a voluntary correction relating to the labeling and software ass... | Class II | Intuitive Surgical, Inc. |
| Sep 17, 2014 | Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Gene... | A failure of a specific component may prevent the ventilators from operating on AC power or trans... | Class I | Respironics California Inc |
| Sep 11, 2014 | ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System... | Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of ... | Class II | Intuitive Surgical, Inc. |
| Aug 29, 2014 | Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS4... | Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has d... | Class II | Dako North America Inc. |
| Aug 26, 2014 | The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm... | The expiration date of the bar code on the envelope label did not match the expiration date next ... | Class II | MAST Biosurgery USA, Inc |
| Aug 25, 2014 | Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises dilu... | Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated plate... | Class II | Beckman Coulter Inc. |
| Aug 21, 2014 | UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices use... | Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may... | Class II | Beckman Coulter Inc. |
| Aug 19, 2014 | Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD... | An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damag... | Class II | St Jude Medical Cardiac Rhythm Management Division |
| Aug 19, 2014 | 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Contr... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 18, 2014 | 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provi... | Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by th... | Class II | Varian Medical Systems, Inc. |
| Aug 15, 2014 | Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174A... | Medtronic has decided to discontinue production and distribution of this low-volume product. | Class II | Medtronic Cardiovascular Surgery-the Heart Valv... |
| Aug 13, 2014 | V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (... | Reports of deterioration of material covering the articulating section of the V5Ms transesophagea... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 13, 2014 | Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; S... | Internal testing had identified a potential breach to the sterile barrier that may impact the ste... | Class II | Volcano Corporation |
| Aug 11, 2014 | ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX P... | Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability c... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 8, 2014 | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... | Class II | Beckman Coulter, Inc. |
| Aug 6, 2014 | iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only... | One lot may not have been properly sealed, resulting in a non-sterile device. | Class II | Ellex iScience, Inc. |
| Aug 5, 2014 | CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes a... | ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... | Class II | ICU Medical, Inc. |
| Aug 5, 2014 | Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefil... | ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... | Class II | ICU Medical, Inc. |
| Aug 5, 2014 | Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefill... | ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... | Class II | ICU Medical, Inc. |
| Jul 28, 2014 | Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina M... | A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.... | Class II | Illumina Inc |
| Jul 24, 2014 | Philips IntelliSpace PACS 4.4 image management systems performs digital image... | A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information... | Class II | Philips Healthcare Informatics, Inc. |
| Jul 21, 2014 | Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Us... | Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue t... | Class II | Medtronic MiniMed Inc. |
| Jul 18, 2014 | BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete ... | The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be ... | Class III | BD Biosciences, Systems & Reagents |
| Jul 18, 2014 | Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flu... | ICU has become aware of an issue with a component where the connection on an arterial monitoring ... | Class II | ICU Medical, Inc. |
| Jul 18, 2014 | Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stri... | ICU has become aware of an issue with a component where the connection on an arterial monitoring ... | Class II | ICU Medical, Inc. |
| Jul 18, 2014 | Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 0... | ICU has become aware of an issue with a component where the connection on an arterial monitoring ... | Class II | ICU Medical, Inc. |
| Jul 18, 2014 | Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm... | ICU has become aware of an issue with a component where the connection on an arterial monitoring ... | Class II | ICU Medical, 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.