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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Nov 17, 2025 Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: ... The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic... Class II SEASPINE ORTHOPEDICS CORPORATION
Aug 6, 2025 Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System Inserter, used as part of a system with an intervertebral body fusion device, may contribute to d... Class II SEASPINE ORTHOPEDICS CORPORATION
Oct 29, 2024 Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small ... Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... Class II SEASPINE ORTHOPEDICS CORPORATION
Oct 29, 2024 Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small... Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... Class II SEASPINE ORTHOPEDICS CORPORATION
Jun 4, 2024 Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/... Insufficient weld around the cap component of the instrument is insufficient to withstand impact... Class II SEASPINE ORTHOPEDICS CORPORATION
May 17, 2024 Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm ... Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone... Class II SEASPINE ORTHOPEDICS CORPORATION
May 17, 2024 Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm ... Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone... Class II SEASPINE ORTHOPEDICS CORPORATION
Feb 28, 2024 Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alph... Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk... Class II SEASPINE ORTHOPEDICS CORPORATION
Feb 15, 2024 Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial ... Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperativ... Class II SEASPINE ORTHOPEDICS CORPORATION

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.