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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DateProductReasonClassFirm
Nov 3, 2022 DeRoyal FOOT PACK, REF 89-9252.08 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal VIT RD PACK 86ST, REF 89-7308.09 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal MYELOGRAM PACK, REF 89-9304.05 XXX Class II DeRoyal Industries Inc
Oct 28, 2022 EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Ba... Class II MicroPort Orthopedics Inc.
Oct 28, 2022 EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Ba... Class II MicroPort Orthopedics Inc.
Oct 27, 2022 NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based co... A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of ... Class II Medacta Usa Inc
Sep 30, 2022 Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem... The tibial tray lock detail is oversized (larger than specification). Class II Wright Medical Technology, Inc.
Sep 30, 2022 Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem... The tibial tray lock detail is oversized (larger than specification). Class II Wright Medical Technology, Inc.
Aug 12, 2022 DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors Procedure packs contained a recalled product. Class II DeRoyal Industries Inc
Aug 3, 2022 stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright ... The outer label does not match the device inside the package. The affected lot of EVOLVE Proline ... Class II Wright Medical Technology, Inc.
Aug 3, 2022 stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wrigh... The outer label does not match the device inside the package. The affected lot of EVOLVE Proline ... Class II Wright Medical Technology, Inc.
Jul 27, 2022 Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00... An incorrect sizing label was applied to the carton packaging. Class II Wright Medical Technology, Inc.
Jul 15, 2022 DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release... The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap... Class II DeRoyal Industries Inc
Jun 27, 2022 (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. ... The product was mispackaged (swapped). The devices within the inner tray matches the inner tray ... Class II Smith & Nephew, Inc.
Jun 14, 2022 Wright EVOLVE TRIAD Plate Cutter, REF 49510120 The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-w... Class II Wright Medical Technology, Inc.
Jun 2, 2022 Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-... The instrument is incorrectly color coded. Class II Wright Medical Technology, Inc.
May 4, 2022 PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. Class II MicroPort Orthopedics Inc.
Apr 19, 2022 LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5 It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARRO... Class II Smith & Nephew Inc
Apr 13, 2022 GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 A Size 2 trial baseplate was assembled with Size 1 instrument sets. Class II Medacta Usa Inc
Mar 10, 2022 EasyFuse Dynamic Compression System Instrument Pack The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide b... Class II Wright Medical Technology, Inc.
Mar 3, 2022 DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhex... A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods... Class II DeRoyal Industries Inc
Mar 3, 2022 DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (ch... A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods... Class II DeRoyal Industries Inc
Mar 3, 2022 DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine glu... A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods... Class II DeRoyal Industries Inc
Feb 15, 2022 Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 520... An incorrect screw is packaged in the product, which contains a locking screw instead of a non-lo... Class II Wright Medical Technology, Inc.
Feb 9, 2022 The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram... Product was labelled with the incorrect manufacturing and distribution dates. Class II Wright Medical Technology, Inc.
Jan 4, 2022 INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw Class II Smith & Nephew, Inc.
Dec 14, 2021 Acufex Access Advanced Positioning Kit - indicated for use to position and di... Products were shipped to the Global Distribution Center instead of the sterilizer and therefore p... Class II Smith & Nephew, Inc.
Dec 3, 2021 Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430. The incorrect product is contained in the packaging. Class II Wright Medical Technology Inc
Dec 3, 2021 Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7m... Incorrect product is contained in the packaging. Class II Wright Medical Technology, Inc.
Dec 3, 2021 Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. The incorrect product is contained in the packaging. Class II Wright Medical Technology Inc
Nov 19, 2021 Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set... Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest w... Class II Medtronic Sofamor Danek USA Inc
Nov 4, 2021 INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS The package contents and package labeling do not match. Class II Wright Medical Technology Inc
Nov 4, 2021 INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS The package contents and package labeling do not match. Class II Wright Medical Technology Inc
Nov 1, 2021 smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... Class II Smith & Nephew, Inc.
Nov 1, 2021 smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202 Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... Class II Smith & Nephew, Inc.
Nov 1, 2021 smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102 Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... Class II Smith & Nephew, Inc.
Nov 1, 2021 smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... Class II Smith & Nephew, Inc.
Oct 25, 2021 Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM... The labels on the packages of screws were switched. Class II Smith & Nephew, Inc.
Sep 20, 2021 6.5MMX165MM CANNULATED SCREW The product label incorrectly indicated that the screws are fully threaded, but the screws contai... Class II Smith & Nephew, Inc.
Sep 2, 2021 DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming... DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming Syst... Class I Deroyal Industries, Inc. Lafollette
Sep 2, 2021 Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, N... Engraving on implants may not match what is listed on the pouch labels. Class II Medtronic Sofamor Danek USA Inc
Sep 2, 2021 Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, N... Engraving on implants may not match what is listed on the pouch labels. Class II Medtronic Sofamor Danek USA Inc
Aug 24, 2021 ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmissio... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I National Distribution & Contracting Inc
Aug 24, 2021 ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I National Distribution & Contracting Inc
Aug 19, 2021 P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 The rear heater plate and cover assembly that contains the electrical wiring for the heaters does... Class II Fort Defiance Industries, LLC
Aug 18, 2021 CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Produc... Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. Class II In2bones USA, LLC
Jul 23, 2021 AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343 The kit contains the wrong vial tray in the package. Class II BioMimetic Therapeutics, LLC
May 19, 2021 LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, ... The device components experienced a manufacturing process error that resulted in surface damage f... Class II Smith & Nephew, Inc.
May 14, 2021 DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... Class I 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.