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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Sep 30, 2024 Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straig... Due to potential issues with design, manufacturing and documentation issues related to the valida... Class II NuVasive Specialized Orthopedics, Inc.
Nov 1, 2022 NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine dur... During accelerated shelf-life extension studies it was noted that the final packaging was experie... Class II NuVasive Specialized Orthopedics, Inc.
Oct 29, 2021 NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: ... The Instructions for Use have been updated to include: (1) Clarification that the device is int... Class II NuVasive Specialized Orthopedics, 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
Jun 25, 2019 MAGEC 1 System Safety Alert to all surgeons informing them of post-implantation fractures of an internal metalli... Class II NuVasive Specialized Orthopedics, 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.