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.

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DateProductReasonClassFirm
Aug 18, 2020 MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AM... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description):... XXX Class II Ameditech Inc
Aug 18, 2020 MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP3... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item N... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProS... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ ... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-214... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNIN... The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690... Class II Beckman Coulter Inc.
Aug 18, 2020 Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): ... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-10... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA ... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number ... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 18, 2020 First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number... Various immunoassay enzymes failed product performance, thereby the products do not consistently ... Class II Ameditech Inc
Aug 6, 2020 The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv... COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes... Class II Life Technologies Corporation
Aug 6, 2020 Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirco... The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shr... Class II Talladium Inc
Aug 6, 2020 The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv... COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes... Class II Life Technologies Corporation
Aug 4, 2020 Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 Tube trays may leak which could invalidate patient results or assay worklists, causing delayed re... Class II Hologic, Inc
Aug 4, 2020 PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT ... The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre... Class I CareFusion 303, Inc.
Aug 4, 2020 BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alari... The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in... Class I CareFusion 303, Inc.
Aug 4, 2020 BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, ... Infusion pump component defect may result in interruption of patient monitoring Class II CareFusion 303, Inc.
Aug 4, 2020 Alaris System PC Unit Model 8015 The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre... Class I CareFusion 303, Inc.
Aug 4, 2020 BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assemb... Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress p... Class I CareFusion 303, Inc.
Jul 27, 2020 Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual:... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual:... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual:... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual:... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z184... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z184... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual:... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 27, 2020 Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z184... Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray ... Class II Karl Storz Endoscopy
Jul 24, 2020 DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intend... Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user o... Class II Ra Medical Systems, Inc.
Jul 24, 2020 NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur... During explantation, standard removal tools can generate sufficient forces to cause distal plug t... Class II Nuvasive Specialized Orthopedics Inc
Jul 21, 2020 Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI:... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKI... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI:... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: ... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: ... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: ... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI:... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKI... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 15, 2020 The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by pat... As a result of the release of new software version to CareLink Personal website, the IOS app for ... Class II Medtronic Inc.
Jul 8, 2020 System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Pr... During a procedure, when images were acquired, and these images were transferred to PACS /image a... Class II Canon Medical System, USA, 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.