Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

Date	Product	Reason	Class	Firm
Dec 21, 2015	Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syr...	All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month sh...	Class II	Baxter Corporation Englewood
Dec 21, 2015	VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifie...	Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem...	Class II	Ortho-Clinical Diagnostics
Dec 18, 2015	Oncentra External Beam - VMAT - Radiation therapy planning system Product ...	When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare...	Class II	Elekta, Inc.
Dec 18, 2015	BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model...	Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.	Class II	C.R. Bard, Inc.
Dec 18, 2015	BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for u...	Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.	Class II	C.R. Bard, Inc.
Dec 18, 2015	Mavig Monitor Suspension System, Model GD60, contained in the following Fluor...	GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm wi...	Class II	GE Medical Systems, LLC
Dec 18, 2015	Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manu...	Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.	Class II	Stryker Spine
Dec 18, 2015	arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Ca...	One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test...	Class I	Arkray Factory USA, Inc.
Dec 18, 2015	BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bla...	Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.	Class II	C.R. Bard, Inc.
Dec 18, 2015	Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA02...	Potential for the parts to crack.	Class II	Value Plastics, Inc.
Dec 18, 2015	Fuse 1C Colonoscope	The bending section of the device may partially separate from the insertion tube. Potential for t...	Class II	EndoChoice, Inc.
Dec 18, 2015	NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three si...	Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result ...	Class II	NeoCoil, LLC
Dec 18, 2015	arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDT...	One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test...	Class I	Arkray Factory USA, Inc.
Dec 18, 2015	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Co...	This Lot is not meeting labeled on-board instrument stability claims of 5 days.	Class II	Instrumentation Laboratory Co.
Dec 18, 2015	VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjuncti...	Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring ...	Class II	Cyberonics, Inc
Dec 17, 2015	Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Mo...	Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single p...	Class II	Stryker Sustainability Solutions
Dec 17, 2015	RadSuite, a picture archive and communications system. Model Numbers Versions...	Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.	Class II	Merge Healthcare, Inc.
Dec 17, 2015	BrightView X are gamma cameras; Designed for single or dual detector nuclear ...	The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardia...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 17, 2015	BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emi...	The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardia...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 17, 2015	BrightView are gamma cameras; Designed for single or dual detector nuclear im...	The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardia...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 17, 2015	Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Cat...	Devices reported to have a smooth texture to the outer surface of the metal, which differed from ...	Class II	Arthrex, Inc.
Dec 16, 2015	AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody de...	There were two potential interference conditions identified with the way the tubing set attaches ...	Class II	Stryker Spine
Dec 16, 2015	Cardiosave Hybrid and rescue IABP	Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet...	Class II	Maquet Datascope Corp - Cardiac Assist Division
Dec 16, 2015	GE Inspection Technologies, LP, Cabinet X-ray system used for industrial qual...	GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems ma...	Class II	GE Inspection Technologies, LP
Dec 15, 2015	GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avanc...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 15, 2015	D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully ...	On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID whe...	Class II	Bio-Rad Laboratories, Inc.
Dec 15, 2015	Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 15, 2015	Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View S...	An issue with the Panorama Central Station may cause the system to spontaneously restart. This ma...	Class II	Mindray DS USA, Inc. dba Mindray North America
Dec 15, 2015	GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia ...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 15, 2015	GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. ...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 15, 2015	GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 15, 2015	Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. ...	The cannulae may bend during procedure.	Class II	Globalmed Logistix
Dec 15, 2015	Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR18...	The door latch may not fully close and the door may open unexpectedly. The door may make physica...	Class II	Fresenius Medical Care Renal Therapies Group, LLC
Dec 15, 2015	MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Inte...	Due to Operator Console software anomaly, a change in treatment completion status of the last pat...	Class II	MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Dec 15, 2015	GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda ...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 14, 2015	FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.	Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting function...	Class III	Becton, Dickinson and Company, BD Biosciences
Dec 14, 2015	Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; ...	Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assem...	Class II	Mizuho OSI
Dec 14, 2015	BD Viper LT software, version 3.00H	BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper ...	Class II	Bd Diagnostic
Dec 11, 2015	CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows:...	Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor ...	Class III	Terumo Cardiovascular Systems Corporation
Dec 11, 2015	MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube ...	The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.	Class II	Benlan, Inc.
Dec 10, 2015	Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices ...	The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it...	Class II	Boston Scientific Corporation
Dec 10, 2015	Flow-i Anesthesia System Product Usage: The indication for the Flow-i Ane...	Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit ...	Class I	Maquet Cardiovascular Us Sales, Llc
Dec 10, 2015	IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2	When the electric lift table is connected to the mains power, in a very rare occasion, the table ...	Class II	Iba Dosimetry Gmbh
Dec 10, 2015	Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Co...	Due to a malfunction of software, the secondary module will not automatically take over messaging...	Class II	Ascom US, INC.
Dec 10, 2015	Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices t...	The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it...	Class II	Boston Scientific Corporation
Dec 9, 2015	BD Intelliport Medication Management System Sensor The system is indicated...	The sterility of the product cannot be assured. This may result in increased risk of infection.	Class II	Becton Dickinson & Company
Dec 9, 2015	Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: ...	Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow dire...	Class II	Philips Ultrasound, Inc.
Dec 9, 2015	Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight ...	The product on the package label did not match what was inside the package. The label was for par...	Class II	Zimmer Biomet, Inc.
Dec 9, 2015	Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; ...	Product on the package label did not match what was inside the package. The label was for part...	Class II	Zimmer Biomet, Inc.
Dec 9, 2015	MOSAIQ Oncology Information System MOSAIQ is an oncology information syste...	Incorrect drug dosage due to "Age Limit" and patient weight data item issue.	Class II	Elekta, 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.