Browse Device Recalls

34 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34 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 34 FDA device recalls.

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DateProductReasonClassFirm
Sep 24, 2024 REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COM... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERI... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KI... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, R... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT,... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COAT... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)1803... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COA... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127M... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPL... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT S... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COAT... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280M... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Jan 30, 2018 TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Size... The firm received complaints regarding the incompatibility and dimensional interference between ... Class II Orthofix Srl
Jul 5, 2017 Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold indiv... The power drill torque limiter may break during use in surgery application. Class II Orthofix Srl

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.