Browse Device Recalls

20 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 20 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 20 FDA device recalls.

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DateProductReasonClassFirm
Dec 19, 2025 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist ... The supplier manufactured anatomical left plates with an incorrect thread orientation. Class II Tyber Medical
Dec 19, 2025 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist ... The supplier manufactured anatomical left plates with an incorrect thread orientation. Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate,... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left In... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 1... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Mod... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right ... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 1... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. ... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fi... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right In... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right I... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Inten... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Int... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical

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.