Browse Device Recalls
4,606 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,606 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 4,606 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 2, 2013 | Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System... | Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, inclu... | Class II | Beckman Coulter Inc. |
| Oct 1, 2013 | TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquil... | Toshiba intitiated this recall because their investigation revealed that due to a problem of the ... | Class II | Toshiba American Medical Systems Inc |
| Oct 1, 2013 | Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 | InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV I... | Class III | Helix Medical LLC |
| Sep 26, 2013 | Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Di... | Distal Access Catheters were shipped to US customers with the Directions for Use that included in... | Class II | Concentric Medical Inc |
| Sep 24, 2013 | COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyz... | The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and C... | Class II | Beckman Coulter Inc. |
| Sep 24, 2013 | UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel Dx... | Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 62... | Class II | Beckman Coulter Inc. |
| Sep 23, 2013 | ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo... | A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and... | Class II | Volcano Corp |
| Sep 23, 2013 | Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Cont... | Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN ... | Class III | Alere San Diego, Inc. |
| Sep 23, 2013 | Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure Sys... | A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and... | Class II | Volcano Corp |
| Sep 23, 2013 | Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure Syst... | A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and... | Class II | Volcano Corp |
| Sep 18, 2013 | STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Steril... | Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because i... | Class II | Advanced Sterilization Products |
| Sep 18, 2013 | STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperat... | Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRA... | Class II | Advanced Sterilization Products |
| Sep 16, 2013 | STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Produ... | This corrective action will address an identified failure of the lamp and illumination system wit... | Class II | Abbott Medical Optics, Inc. |
| Sep 16, 2013 | STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product... | This corrective action will address an identified failure of the lamp and illumination system wit... | Class II | Abbott Medical Optics, Inc. |
| Sep 16, 2013 | Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for Uni... | Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. diffi... | Class II | Sekisui Diagnostics LLC |
| Sep 16, 2013 | STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-24... | This corrective action will address an identified failure of the lamp and illumination system wit... | Class II | Abbott Medical Optics, Inc. |
| Sep 16, 2013 | NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; M... | Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the ... | Class II | Medtronic Vascular, Inc. |
| Sep 16, 2013 | STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalo... | This corrective action will address an identified failure of the lamp and illumination system wit... | Class II | Abbott Medical Optics, Inc. |
| Sep 13, 2013 | NX3 Try-In Gel. The product is used as a tooth shade resin material. | Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-... | Class II | Kerr/Pentron, DBA Kerr Corporation and Pentron ... |
| Sep 13, 2013 | Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. T... | Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly l... | Class II | Southern Implants, Inc |
| 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 |
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.