Browse Device Recalls

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 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 18 FDA device recalls.

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DateProductReasonClassFirm
Jan 23, 2026 Pelvic Reconstruction System (PRS) with the below descriptions and correspond... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 Volar Radius Plate with Angular Stability with the following description: Rad... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 Pilonplate with Angular Stability, with the below descriptions and correspond... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 FR.O.H. Calcaneus Repair System with the following description: Anterolateral... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) Syst... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 Brand Name: Humeral Head Plate with Angular Stability, with the following des... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 Claviculaplate with Angular Stability, with the below descriptions and associ... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 I.T.S. Fibula Plate PROlock with Angular Stability with the below description... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 I.T.S. LRS (Locking Reconstruction System) with the below descriptions and co... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with t... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 I.T.S. Straight Plate with Angular Stability with the below descriptions and ... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 Distal Humeral Plates with Angular Stability with the below descriptions and ... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 HLS - Hand Locking Plates System with the below descriptions and correspondin... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 I.T.S. Screw System with the below descriptions and corresponding article num... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 Olecranonplate with Angular Stability with the below descriptions and corresp... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate wit... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
Jan 23, 2026 HCS - Headless Compression Screw System, Headless Compression Screw, Cannulat... Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI... Class II I.T.S. GmbH
May 9, 2019 Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usa... The titanium implant has the wrong article number laser marked on it. Class II I.T.S. GmbH

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.