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
Sep 12, 2013 Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay Sy... Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fus... Class II Beckman Coulter Inc.
Sep 9, 2013 ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemi... The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry An... Class II Beckman Coulter Inc.
Sep 9, 2013 ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Ana... The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry An... Class II Beckman Coulter Inc.
Sep 6, 2013 ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essentia... HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting ... Class III Horiba Instruments, Inc dba Horiba Medical
Sep 5, 2013 Product Name: AVEA¿ Ventilator. All Models. The affected devices are clear... CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher ... Class I Carefusion 211 Inc dba Carefusion
Aug 30, 2013 CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are us... CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date.... Class II CareFusion 303, Inc.
Aug 30, 2013 Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical dev... When positioning the display located on top of the video cart, it is possible for the user to app... Class II Stryker Endoscopy
Aug 30, 2013 SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing... CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 1301631... Class II CareFusion 303, Inc.
Aug 30, 2013 SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administr... CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is... Class II CareFusion 303, Inc.
Aug 30, 2013 Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. ... Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (L... Class II Implantech Associates Inc
Aug 26, 2013 Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/0884261... Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of li... Class II Bayer Healthcare Llc
Aug 21, 2013 Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: Mi... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan plus Negative Combo 3 Sold outside of US only. Product Usage:... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: Mi... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Syne... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan plus Negative Urine Combo 4 Sold outside of US only. Product ... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Pro... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: Mic... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: Micro... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013 Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroSca... Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop... Class I Siemens Healthcare Diagnostics, Inc.
Aug 16, 2013 POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006.... Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter becau... Class II Access Scientific Inc
Aug 5, 2013 Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic im... The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be... Class II Toshiba American Medical Systems Inc
Aug 5, 2013 Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic... The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be... Class II Toshiba American Medical Systems Inc
Aug 5, 2013 Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic... The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be... Class II Toshiba American Medical Systems Inc
Aug 5, 2013 Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic... The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has be... Class II Toshiba American Medical Systems Inc
Aug 1, 2013 NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.... Under certain circumstances, the Left eye image may be saved as the Right eye image. Class II Nidek Inc
Jul 31, 2013 "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors ... The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance ... Class II Edwards Lifesciences, LLC
Jul 25, 2013 STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization Sys... The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (... Class II Advanced Sterilization Products
Jul 23, 2013 DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott L... Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an un... Class II Microgenics Corp
Jul 19, 2013 Pipeline Embolization Device (PED) The Pipeline Embolization Device is ind... Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
Jul 18, 2013 PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/... Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT... Class II Siemens Medical Solutions USA, Inc
Jul 17, 2013 Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually r... Beckman Coulter has received a customer complaint that suggests trending of positive results has... Class II Beckman Coulter Inc.
Jul 16, 2013 Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (... Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. ... Class III Zoll Circulation, Inc.
Jul 12, 2013 Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. ... Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws ... Class II Ormco/Sybronendo
Jul 12, 2013 OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution cont... The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the ... Class III Celera Corporation
Jul 10, 2013 Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-ster... PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Mar... Class II Precision Dynamics Corporation
Jul 10, 2013 Acuson SC2000 volume imaging ultrasound systems at software version 3.0. M... Software issue results in inaccurate 3D image may result in ablation in wrong location. Class II Siemens Medical Solutions USA, Inc.
Jul 3, 2013 Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332... Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and... Class II Medtronic MiniMed
Jun 28, 2013 Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated f... Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer cart... Class II Medtronic Neurosurgery
Jun 28, 2013 Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior F... The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 4... Class II Alphatec Spine, Inc.
Jun 24, 2013 Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Cat... The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner... Class II Stryker Neurovascular
Jun 21, 2013 Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surg... The outer box label of the product was labeled with a down revision label which did not include t... Class II Myoscience Inc
Jun 19, 2013 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilita... Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly ... Class II Biosense Webster, Inc.
Jun 17, 2013 Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic bo... CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is ope... Class I CareFusion 303, Inc.
Jun 10, 2013 Afinity CQ2015A Intraocular Lens The visual correction of aphakia in perso... STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intr... Class II Staar Surgical Co.
Jun 10, 2013 nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of a... STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intr... Class II Staar Surgical Co.
Jun 8, 2013 da Vinci Instrument Control Box, model number ICB3000; Manufactured by Int... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuit... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, 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.