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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Dec 20, 2024 Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-... Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). Class II Integrity Implants Inc.
Aug 3, 2022 LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - D... Potential for intraoperative screw head separation at weld location. Class II Integrity Implants Inc.
Jan 27, 2022 LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-ca... Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... Class II Integrity Implants Inc.
Jan 27, 2022 LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated.... Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... Class II Integrity Implants Inc.
Jan 27, 2022 LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannul... Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... Class II Integrity Implants Inc.
Feb 27, 2018 FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) ... Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of thei... Class II Integrity Implants 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.