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Browse Device Recalls

249 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 249 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 249 FDA device recalls.

Clear
DateProductReasonClassFirm
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Oct 21, 2019 C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Cr... Class II Integra LifeSciences Corp.
Sep 12, 2019 Cerelink ICP Monitor, Model Number 826820; intended for use as an interface ... There is a potential for a progressive decline in observed ICP readings of the monitor during use. Class II Integra LifeSciences Corp.
Aug 7, 2019 Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic p... A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce... Class II Integra LifeSciences Corp.
Jul 19, 2019 Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, gr... Tips have an inadequate product insulation coating, which could result in the tips not coagulatin... Class II Integra LifeSciences Corp.
Apr 8, 2019 MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniT... The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... Class I Integra LifeSciences Corp.
Apr 8, 2019 LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS902... The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... Class I Integra LifeSciences Corp.
Apr 8, 2019 MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System ... The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... Class I Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right,... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, P... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, ... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.

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.