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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

755 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 755 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 755 FDA device recalls in TN.

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DateProductReasonClassFirm
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Nov 14, 2018 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Nu... The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. T... Class II In2bones USA, LLC
Sep 27, 2018 INFUSE Bone Graft X SMALL KIT REF 7510100 The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sp... Class II Medtronic Sofamor Danek USA Inc
Sep 18, 2018 Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 RE... One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring. Class II Smith & Nephew, Inc.
Jul 16, 2018 CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones ... CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, righ... Class II In2bones USA, LLC
Jul 16, 2018 CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones ... CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, righ... Class II In2bones USA, LLC
Jul 9, 2018 Medtronic CD HORIZON Spinal System is intended to help provide immobilization... This lot has incorrectly been laser marked both on the screw head itself as well as the data carr... Class II Medtronic Sofamor Danek USA Inc
Jun 13, 2018 Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 7402121... The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Aust... Class II Smith & Nephew, Inc.
Jun 13, 2018 JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 7402... The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Aust... Class II Smith & Nephew, Inc.
Jun 13, 2018 JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 7402... The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Aust... Class II Smith & Nephew, Inc.
May 24, 2018 FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 653... During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar ... Class II Fort Defiance Industries, LLC
May 11, 2018 Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) S... The affected devices are manufactured to the same design specification as products intended for s... Class II Smith & Nephew, Inc.
May 11, 2018 Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF... The affected devices are manufactured to the same design specification as products intended for s... Class II Smith & Nephew, Inc.
May 4, 2018 smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1) One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. Class II Smith & Nephew, Inc.
May 2, 2018 smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x... Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length.... Class II Smith & Nephew, Inc.
Apr 23, 2018 DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4... Non-sterile product was packaged inside a case that was labeled as sterile. Class II DeRoyal Industries Inc
Apr 9, 2018 smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 7... A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error.... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, ... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM,... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM,... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, ... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 23, 2018 Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Si... Slot screw had an overall length of 15mm, but per the specification, the screw should have an ove... Class II Medtronic Sofamor Danek USA Inc
Mar 14, 2018 WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L... Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. Class II Wright Medical Technology, Inc.
Mar 14, 2018 WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L:... Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. Class II Wright Medical Technology, Inc.
Mar 13, 2018 Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, ... The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical ... Class II Medtronic Sofamor Danek USA Inc
Mar 7, 2018 D-RAD Self-Tapping Locking Screw intended for the fixation of fractures invol... One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machine... Class II Smith & Nephew, Inc.
Feb 1, 2018 smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71... The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short... Class II Smith & Nephew, Inc.
Jan 22, 2018 Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A ... DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valv... Class II DeRoyal Industries Inc
Jan 15, 2018 LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71... The affected products were inadvertently packaged with an incorrect screw component. Class II Smith & Nephew, Inc.
Dec 22, 2017 Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only Medtronic has discovered the product lot in question was noted as having a longer drill tip exten... Class II Medtronic Sofamor Danek USA Inc
Dec 19, 2017 DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray wit... DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tr... Class II DeRoyal Industries Inc
Dec 13, 2017 Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401... In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted ... Class II Smith & Nephew, Inc.
Dec 11, 2017 smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating... Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-... Class II Smith & Nephew, Inc.
Dec 11, 2017 smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating... Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-... Class II Smith & Nephew, Inc.
Dec 6, 2017 Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF F... Medtronic has discovered the directional arrow at the proximal end of the instrument may not corr... Class II Medtronic Sofamor Danek USA Inc
Nov 29, 2017 smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER... One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates. Class II Smith & Nephew, Inc.
Nov 15, 2017 Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementle... Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem. Class II Medacta Usa Inc
Oct 24, 2017 smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (deg... A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside ... Class II Smith & Nephew, Inc.
Oct 24, 2017 The GMK knee system: designed for cemented use in total knee arthroplasty. S... Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of appro... Class II Medacta Usa Inc
Oct 23, 2017 Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone. The expiration date provided on the label is incorrect. Class II Smith & Nephew, Inc.
Oct 16, 2017 DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep ... Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled ... Class II DeRoyal Industries Inc
Sep 18, 2017 MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERIL... The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead... Class II MicroPort Orthopedics Inc.
Sep 14, 2017 smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL W... The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw. Class II Smith & Nephew, Inc.
Aug 3, 2017 Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system "Chattering" when cutting burrs are used in bone. Class II Gyrus ACMI, Inc.
Aug 1, 2017 GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF... Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing G... Class II Smith & Nephew, Inc.
Jul 24, 2017 smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgu... The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after mu... Class II Smith & Nephew, Inc.
Jun 7, 2017 DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolp... Lack of sterility assurance. There is a defect in the primary packaging of the device, which may... Class II DeRoyal Industries Inc

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.