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Browse Device Recalls

278 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 278 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 278 FDA device recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek ... 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.
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.
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 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.
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 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.
May 30, 2017 LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971... The incorrect Loctite adhesive was used to assemble the impactor heads. Class II Smith & Nephew, Inc.
May 30, 2017 LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977... The incorrect Loctite adhesive was used to assemble the impactor heads. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QT... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY... The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 30, 2017 RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1) The stability data does not support the product labeled with a 10-year shelf life. Class II Smith & Nephew, Inc.
Mar 22, 2017 PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH,... This lot of left plates were laser etched and packaged as right plates. Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 7220404... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 722040... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, Inc.
Mar 15, 2017 Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 ... Potential for the cutting blade to detach from the device and/or the distal drill head to fractur... Class II Smith & Nephew, 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.