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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Feb 12, 2021 NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System ... Due to not having the full complement of biological assessments for all potential patients and as... Class II Nuvasive Specialized Orthopedics Inc
Feb 12, 2021 Precice Bone Transport - Product Usage: intended for limb lengthening, open... Due to complaints of adverse events potentially related to biological safety. The complaints inc... Class II Nuvasive Specialized Orthopedics Inc
Feb 12, 2021 NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening Syst... Due to not having the full complement of biological assessments for all potential patients and as... Class II Nuvasive Specialized Orthopedics Inc
Feb 12, 2021 NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail Sys... Due to not having the full complement of biological assessments for all potential patients and as... Class II Nuvasive Specialized Orthopedics Inc
Feb 12, 2021 PRECICE STRYDE - Product Usage: intended for limb lengthening, open and clo... Due to complaints of adverse events potentially related to biological safety. The complaints inc... Class II Nuvasive Specialized Orthopedics Inc
Feb 12, 2021 PRECICE PLATE - Product Usage: intended for limb lengthening, open and clos... Due to complaints of adverse events potentially related to biological safety. The complaints inc... 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

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.