Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC
Apr 23, 2025 Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque u... Potential breach of sterile barrier packaging. Class II Mozarc Medical US LLC
Apr 23, 2025 MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. Potential breach of sterile barrier packaging. Class II Mozarc Medical US LLC
Apr 23, 2025 Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque ... Potential breach of sterile barrier packaging. Class II Mozarc Medical US LLC
Apr 23, 2025 Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque... Potential breach of sterile barrier packaging. Class II Mozarc Medical US LLC
Apr 23, 2025 Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque ure... Potential breach of sterile barrier packaging. Class II Mozarc Medical US LLC

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.