Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Date	Product	Reason	Class	Firm
Dec 30, 2016	Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable ...	Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops,...	Class II	Hospira Inc., A Pfizer Company
Dec 29, 2016	Synthes Radial Head Prosthesis System, Surgical instrument motors and accesso...	There is the possibility that the radial stem may loosen post-operatively at the stem bone interf...	Class II	Synthes (USA) Products LLC
Dec 28, 2016	Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered ...	Powdered Surgical Gloves are an FDA banned substance.	Class II	American Contract Systems, Inc.
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm D...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm D...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm D...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 28, 2016	Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Dis...	Product sterility compromised due to breach of sterile barrier	Class II	Medtronic Advanced Energy, LLC
Dec 27, 2016	Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray...	Patient fell from the table because the footrest of the device detached from the table top while ...	Class II	Villa Sistemi Medicali S.P.A.
Dec 27, 2016	AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcate...	Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas...	Class II	Endologix
Dec 27, 2016	AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA Sy...	Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas...	Class II	Endologix
Dec 27, 2016	Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with In...	May experience a loss of centralized monitoring.	Class II	Philips Electronics North America Corporation
Dec 27, 2016	AFX Endovascular AAA System, Endoleak Type IIIA	Endologix initiated a correction by updating reports for the cumulative clinical data and informa...	Class II	Endologix
Dec 27, 2016	AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX En...	Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas...	Class II	Endologix
Dec 27, 2016	cobas p 612 pre-analytical system; Pre-analytical sample handling that inc...		Class II	Roche Diagnostics Corporation
Dec 27, 2016	OEC 9800. MDL Numbers: D222250, D141598	GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due ...	Class II	GE OEC Medical Systems, Inc
Dec 27, 2016	Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ra...	Patient fell from the table because the footrest of the device detached from the table top while ...	Class II	Villa Sistemi Medicali S.P.A.
Dec 27, 2016	AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcat...	Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas...	Class II	Endologix
Dec 27, 2016	OEC 9900 Elite. MDL Numbers: D148942, D155043	GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due ...	Class II	GE OEC Medical Systems, Inc
Dec 27, 2016	Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9...	Patient fell from the table because the footrest of the device detached from the table top while ...	Class II	Villa Sistemi Medicali S.P.A.
Dec 27, 2016	AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcate...	Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovas...	Class II	Endologix
Dec 27, 2016	Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003	The affected products have approximately a 91% specificity while the non-affected lots have appro...	Class II	Immuno-Mycologics, Inc
Dec 27, 2016	Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray syst...	Patient fell from the table because the footrest of the device detached from the table top while ...	Class II	Villa Sistemi Medicali S.P.A.
Dec 23, 2016	BrightView XCT	The intended use listed in the English and localized language IFUs for BrightView XCT systems did...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 23, 2016	Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Referenc...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 ...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	Optilite IgG4 Kit Product Code: LK009.OPT.A	A change to the lower end of the measuring range and product insert did not reflect the change.Th...	Class III	The Binding Site Group, Ltd.
Dec 23, 2016	Brilliance iCT	During a retrospective review of production documentation it was observed that the M6 Rotor Count...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 23, 2016	CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 09...	Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CAR...	Class II	Maquet Datascope Corp - Cardiac Assist Division
Dec 23, 2016	Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-1...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-0...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	BrightView X upgraded to XCT 882454	The intended use listed in the English and localized language IFUs for BrightView XCT systems did...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 23, 2016	Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Refe...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiati...	Cross profile for Varian 60 degree wedge shows "horns."	Class II	Elekta, Inc.
Dec 23, 2016	Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed ...	Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also n...	Class II	Becton Dickinson & Company
Dec 23, 2016	Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 In...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 22, 2016	MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic ...	Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides	Class II	Mako Surgical Corporation
Dec 22, 2016	IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database an...	A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV ...	Class II	AGFA Healthcare Corp.
Dec 22, 2016	Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reportin...	Power outages causes reporting software to shutdown.	Class II	Tosoh Smd Inc
Dec 22, 2016	Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bo...	The product is being recalled due to incidence and reports of the product breaking during surgery.	Class II	Flower Orthopedics Corporation
Dec 21, 2016	AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number:...	AutoDELFIA System with Version 3.0 Software: Potential plate loading failures	Class III	PerkinElmer Health Sciences, Inc.
Dec 21, 2016	Fresenius 2008K Series : Hemodialysis System	When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i...	Class II	Fresenius Medical Care Renal Therapies Group, LLC
Dec 21, 2016	DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number...	AutoDELFIA System with Version 3.0 Software: Potential plate loading failures	Class III	PerkinElmer Health Sciences, 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.