Browse Device Recalls

2,049 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,049 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 2,049 FDA device recalls in N/A.

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Date	Product	Reason	Class	Firm
Dec 2, 2021	Zenition 70, Model #718133	Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 2, 2021	Veradius Unity, Model #718132	Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 2, 2021	Zenition 50, Model #718096	Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issu...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nov 29, 2021	Proteus 235; Version: PTS-8 versions before PTS-8.7.2	Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) ...	Class II	Ion Beam Applications S.A.
Nov 24, 2021	DBB-06 Hemodialysis Delivery System	Device lacks premarket approval.	Class II	Nikkiso Ltd - Shizuoka Plant
Oct 14, 2021	MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007	While cleaning or disinfecting the system, if the process is not followed as described in the man...	Class II	SEDECAL SA
Oct 11, 2021	GM Helix Acqua Implant 3.5x10, Article No. 140.944	3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone qual...	Class II	Jjgc Industria E Comercio De Materials Dentario...
Oct 4, 2021	Cliquid MD version 3.4 software used in conjunction with Analyst MD software ...	The values of the Internal Standard (IS) concentrations are incorrectly derived when the user bui...	Class II	AB SCIEX
Oct 1, 2021	REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=...	There is a potential that the length of bone screws identified on labeling may not correspond to...	Class II	Limacorporate S.p.A
Oct 1, 2021	Ellume COVID-19 Home Test	Due to a higher rate of false positive test results.	Class I	ELLUME LTD
Oct 1, 2021	REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=...	There is a potential that the length of bone screws identified on labeling may not correspond to...	Class II	Limacorporate S.p.A
Sep 28, 2021	Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143;...	There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed ...	Class II	ELEKTA SOLUTIONS AB
Sep 22, 2021	RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations...	An issue where the combined density in a dose grid voxel partially covered by the External ROI an...	Class II	RAYSEARCH LABORATORIES AB
Sep 22, 2021	ROSA One 3.1 Brain application The device is intended for the spatial posi...	The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which le...	Class I	MEDTECH SAS
Sep 10, 2021	FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different br...	The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to a...	Class II	Inpeco S.A.
Sep 9, 2021	TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B...	If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or ...	Class II	RAYSEARCH LABORATORIES AB
Sep 2, 2021	MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System	Under certain conditions, there is a risk for a false negative result.	Class II	BioMerieux SA
Aug 24, 2021	McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16...	Potential for difficulty in safety mechanism activation.	Class II	Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021	McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16...	Potential for difficulty in safety mechanism activation.	Class II	Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021	McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, M...	Potential for difficulty in safety mechanism activation.	Class II	Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021	HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 10...	Potential for difficulty in safety mechanism activation.	Class II	Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021	McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, M...	Potential for difficulty in safety mechanism activation.	Class II	Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021	HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 10...	Potential for difficulty in safety mechanism activation.	Class II	Zhejiang Kindly Medical Devices Co., Ltd.
Aug 11, 2021	EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Red Medical Supplies
Aug 11, 2021	EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Red Medical Supplies
Aug 11, 2021	EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co...	Class I	Red Medical Supplies
Aug 5, 2021	AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product ...	Some devices may be associated with high and unexpected resistance to gas flow during clinical us...	Class I	Armstrong Medical Services Limited
Aug 2, 2021	uMI 550 System - Product Usage: intended to be operated by qualified healthca...	The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Aug 2, 2021	uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified...	The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.	Class II	Shanghai United Imaging Healthcare Co., Ltd.
Jul 30, 2021	Arjo Disposable Repositioning Sling, Model AHD001	Sling loop straps on device pose a trip hazard.	Class II	Getinge Dominican Republic SA
Jul 28, 2021	Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 3...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 3...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, RE...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augm...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, R...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 28, 2021	Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWP...	The packaging system on the devices have potential physical and water damage resulting in damage ...	Class II	Corin Ltd
Jul 21, 2021	CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-...	Device failed to function as intended and/or failed to conform to their design specifications.	Class II	Trophy SAS
Jul 16, 2021	RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numb...	The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo...	Class II	Teleflex Medical Europe Ltd
Jul 16, 2021	RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, RE...	The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo...	Class II	Teleflex Medical Europe Ltd
Jul 16, 2021	RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff...	The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo...	Class II	Teleflex Medical Europe Ltd
Jul 16, 2021	RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numb...	The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo...	Class II	Teleflex Medical Europe Ltd
Jul 14, 2021	smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use duri...	The nail head may become detached during surgery.	Class II	Smith & Nephew Orthopaedics Ltd. (Aurora)
Jul 9, 2021	COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the ...	A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integr...	Class II	Copan Italia
Jul 8, 2021	The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular...	The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S....	Class II	Vascutek, Ltd.
Jul 8, 2021	The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-...	The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S....	Class II	Vascutek, Ltd.
Jul 2, 2021	Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a compon...	There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must n...	Class II	Laboratoires Bodycad, 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.