Browse Device Recalls

155 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 155 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 155 FDA device recalls.

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Date	Product	Reason	Class	Firm
Mar 12, 2024	ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Co...	Product incorrectly labelled.	Class II	DePuy Orthopaedics, Inc.
Feb 15, 2023	Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 1...	The subject product lots are being recalled because they received a higher than specified irradia...	Class II	DePuy Orthopaedics, Inc.
Feb 15, 2023	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part N...	The subject product lots are being recalled because they received a higher than specified irradia...	Class II	DePuy Orthopaedics, Inc.
Feb 15, 2023	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part N...	The subject product lots are being recalled because they received a higher than specified irradia...	Class II	DePuy Orthopaedics, Inc.
Feb 15, 2023	Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Nu...	The subject product lots are being recalled because they received a higher than specified irradia...	Class II	DePuy Orthopaedics, Inc.
Feb 15, 2023	Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part ...	The subject product lots are being recalled because they received a higher than specified irradia...	Class II	DePuy Orthopaedics, Inc.
Jun 29, 2022	ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotatio...	Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless stee...	Class II	DePuy Orthopaedics, Inc.
May 18, 2022	MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metall...	The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instruction...	Class II	DePuy Orthopaedics, Inc.
Mar 11, 2022	VELYS Robotic-Assisted Solution Base Product No.: 451570100	System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) cha...	Class II	DePuy Orthopaedics, Inc.
Jan 5, 2022	ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in t...	May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to...	Class II	DePuy Orthopaedics, Inc.
Jan 5, 2022	ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component ...	May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Dec 7, 2021	GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the...	Class II	DePuy Orthopaedics, Inc.
Sep 9, 2021	ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacem...	Packaging may include screws that are not intended to be used with the 5mm augments, may cause de...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are inten...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intend...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intend...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intend...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are inte...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intend...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Aug 10, 2021	TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intend...	Software: A coding error associated with the Fast3D Segmentation software. During the scanning p...	Class II	DePuy Orthopaedics, Inc.
Jul 1, 2021	ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthropl...	Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a re...	Class II	DePuy Orthopaedics, Inc.
May 7, 2021	DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrai...	Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number an...	Class II	DePuy Orthopaedics, Inc.
Feb 22, 2021	The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Produc...	Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ...	Class II	DePuy Orthopaedics, Inc.
Feb 22, 2021	The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consist...	Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ...	Class II	DePuy Orthopaedics, Inc.
Feb 22, 2021	ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually package...	Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ...	Class II	DePuy Orthopaedics, Inc.
Jan 8, 2021	Universal Femoral Sleeves - Product Usage: used primarily in revision surgeri...	The taper dimensions may be out of specification due to a production issue during the manufacturi...	Class II	DePuy Orthopaedics, Inc.
Dec 15, 2020	Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056...	Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could l...	Class II	DePuy Orthopaedics, Inc.
Jan 3, 2020	SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product i...	The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in...	Class II	DePuy Orthopaedics, Inc.
Sep 21, 2018	CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage:...	There is the potential for debris/material to be found behind the O-rings in the neck trials.	Class II	DePuy Orthopaedics, Inc.
Sep 21, 2018	CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: T...	There is the potential for debris/material to be found behind the O-rings in the neck trials.	Class II	DePuy Orthopaedics, Inc.
Sep 21, 2018	CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Us...	There is the potential for debris/material to be found behind the O-rings in the neck trials.	Class II	DePuy Orthopaedics, Inc.
Jul 18, 2018	P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830	This unit may be missing the screw/collet Assembly	Class II	DePuy Orthopaedics, Inc.
Jun 21, 2018	CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511	Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential ...	Class II	DePuy Orthopaedics, Inc.
Apr 16, 2018	ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral ...	There may be burrs on the extraction hole threads.	Class II	DePuy Orthopaedics, Inc.
Apr 16, 2018	ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral ...	There may be burrs on the extraction hole threads.	Class II	DePuy Orthopaedics, Inc.
Dec 21, 2017	(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100,...	The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system ...	Class II	DePuy Orthopaedics, Inc.
Nov 28, 2017	The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemen...	The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was i...	Class II	DePuy Orthopaedics, Inc.
Aug 31, 2017	DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis...	The affected lots are being recalled because the epiphysis may not assemble to the stem, which ma...	Class II	DePuy Orthopaedics, Inc.
Aug 31, 2017	DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis...	The affected lots are being recalled because the epiphysis may not assemble to the stem, which ma...	Class II	DePuy Orthopaedics, Inc.
Jul 26, 2017	Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixa...	Potential for Intra-operative breakage of driver tips	Class II	DePuy Orthopaedics, Inc.
Jul 26, 2017	Concorde Lift Torque Limiting Handle. Must be used with supplemental int...	Potential for Intra-operative breakage of driver tips	Class II	DePuy Orthopaedics, Inc.
Jul 12, 2017	CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9	Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S...	Class II	DePuy Orthopaedics, Inc.
Jul 12, 2017	CORAIL HIGH OFFSET STEM Collarless SIZE 14	Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S...	Class II	DePuy Orthopaedics, 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.