Browse Device Recalls
286 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 286 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 286 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 4, 2020 | Integra Padgett Dermatome Set - Product Usage: are intended for use in the cu... | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts... | Class II | Integra LifeSciences Corp. |
| Feb 7, 2020 | NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product U... | Nonconforming product which was dispositioned for rejection was mistakenly released for commercia... | Class III | 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. |
| 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. |
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.