Browse Device Recalls

740 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 740 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 740 FDA device recalls in TN.

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Date	Product	Reason	Class	Firm
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
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.
May 19, 2017	Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H...	One lot of product does not include a screw for attachment to the tibial base plate.	Class II	Medacta Usa Inc
May 17, 2017	KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.	The directional arrow at the proximal end of the instrument may not correctly align with the cut...	Class II	Medtronic Sofamor Danek USA Inc
Apr 26, 2017	Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50...	When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the ...	Class II	Iba Dosimetry
Apr 13, 2017	Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE ...	Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles i...	Class II	Medtronic Sofamor Danek USA 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.

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.