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
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
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.

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.