Browse Device Recalls

749 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 749 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 749 FDA device recalls in TN.

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DateProductReasonClassFirm
Apr 9, 2020 WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Prod... One lot of INBONE Tibial Trays is missing the plasma coating. Class II Wright Medical Technology Inc
Mar 26, 2020 VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 Nonconforming product; length of the product measured shorter than the labeled length. Class II Medtronic Sofamor Danek USA Inc
Feb 27, 2020 DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF ... One lot of product was inadvertently manufactured with a buckle which does not meet the mechanica... Class II DeRoyal Industries Inc
Feb 27, 2020 NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissu... Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraopera... Class II Smith & Nephew, Inc.
Feb 6, 2020 Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included... The sterile packaging has the potential to be compromised. Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Feb 4, 2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the fo... Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and u... Class II Deroyal Industries, Inc. Lafollette
Jan 28, 2020 JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usa... The spike rail was manufactured with an oversized thru-hole which could potentially cause the dow... Class II Smith & Nephew, Inc.
Jan 28, 2020 JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usa... The spike rail was manufactured with an oversized thru-hole which could potentially cause the dow... Class II Smith & Nephew, Inc.
Dec 27, 2019 WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222 Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both th... Class II Wright Medical Technology, Inc.
Dec 27, 2019 WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both th... Class II Wright Medical Technology, Inc.
Dec 19, 2019 LEGION PS High Flex XLPE size 5-6 9mm Articular Insert LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part Class II Smith & Nephew, Inc.
Dec 16, 2019 LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6... Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunge... Class II Smith & Nephew, Inc.
Nov 21, 2019 DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3... The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. Class II DeRoyal Industries Inc
Nov 11, 2019 smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROF... There is a a potential failure mode associated with the use of the mallet, wherein the poly tip o... Class II Smith & Nephew, Inc.
Nov 4, 2019 Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through... Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional co... Class II Medacta Usa Inc
Oct 18, 2019 Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (1... FDA determined that marketing claims surrounding product rendered product a medical device which ... Class II Basic Reset Inc.
Oct 7, 2019 LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN In... LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls ... Class II Smith & Nephew, Inc.
Sep 19, 2019 MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw. Class II CrossRoads Extremity Systems, LLC
Jul 22, 2019 DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane... Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the c... Class II DeRoyal Industries Inc
Jun 18, 2019 DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which... Class II DeRoyal Industries Inc
Mar 8, 2019 Olympus Diego Elite Console MDCONS 100 Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB40... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A P... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Feb 19, 2019 smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 ... Complaints were received indicating that the outer label incorrectly identified the product as si... Class II Smith & Nephew, Inc.
Feb 19, 2019 smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZ... Complaints were received indicating that the outer label incorrectly identified the product as si... Class II Smith & Nephew, Inc.
Feb 13, 2019 BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device inten... The firm became aware of the potential for the products' sterile pouch to be punctured during tra... Class II Bioventus, LLC
Jan 7, 2019 SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613 The pin that holds the spring mechanism is not properly mounted. The pin could potentially disass... Class II Smith & Nephew, Inc.
Dec 17, 2018 DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric ... Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes. Class II DeRoyal Industries Inc
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

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.