Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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Date	Product	Reason	Class	Firm
Sep 19, 2018	Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System ...	Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts af...	Class II	Philips Medical Systems Gmbh, DMC
Sep 19, 2018	Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX...	Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failur...	Class II	Encore Medical, Lp
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.
Sep 18, 2018	Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatri...	Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) fu...	Class I	COVIDIEN LLC
Sep 18, 2018	SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009	If an operator attempts to manually program a Basic Infusion for a drug that is not included in t...	Class II	Baxter Healthcare Corporation
Sep 18, 2018	The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A param...	Cross contamination may have occurred between wells for the reagent pack. As a result of this def...	Class II	Beckman Coulter Inc.
Sep 17, 2018	NucliSENS¿ Magnetic Extraction Reagents	Data loggers showed that one shipment to the United States experienced low temperatures that may ...	Class II	BioMerieux SA
Sep 17, 2018	BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with...	The power supply unit for the printer used with the device can potentially overheat or cause a fi...	Class II	Leica Microsystems, Inc.
Sep 17, 2018	Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ra...	O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and...	Class II	Medtronic Navigation, Inc.-Littleton
Sep 17, 2018	Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc...	Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The comp...	Class II	Beckman Coulter Inc.
Sep 17, 2018	Reprocessed Agilis Steerable Introducer: indicated for introducing various c...	Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specific...	Class II	Sterilmed, Inc.
Sep 14, 2018	Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek ...	The pouches of certain lots of product may have wrinkles along the pouch seal that could result i...	Class II	Ecolab Inc
Sep 14, 2018	Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek ...	The pouches of certain lots of product may have wrinkles along the pouch seal that could result i...	Class II	Ecolab Inc
Sep 14, 2018	Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx S...	The pouches of certain lots of product may have wrinkles along the pouch seal that could result i...	Class II	Ecolab Inc
Sep 14, 2018	Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / ...	The pouches of certain lots of product may have wrinkles along the pouch seal that could result i...	Class II	Ecolab Inc
Sep 14, 2018	GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended f...	There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) p...	Class II	GE Healthcare, LLC
Sep 14, 2018	GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH A...	A detector can detach and fall.	Class I	GE Healthcare, LLC
Sep 14, 2018	VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pac...	Potential to lead to a false negative results.	Class II	Luminex Corporation
Sep 14, 2018	SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stocke...	For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycoba...	Class II	LivaNova USA Inc.
Sep 14, 2018	GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Ca...	A detector can detach and fall.	Class I	GE Healthcare, LLC
Sep 14, 2018	GE Healthcare Millennium MC	A detector can detach and fall.	Class I	GE Healthcare, LLC
Sep 13, 2018	Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification...	Inaccurate potassium results may be generated. When testing with control fluid and/or patient sam...	Class II	Abbott Point Of Care Inc.
Sep 13, 2018	3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibul...	There is potential to break during use.	Class II	Arthrex, Inc.
Sep 13, 2018	Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#:...	The service manual was not updated at the time of the release of software version 1.30.	Class II	Terumo Cardiovascular Systems Corporation
Sep 13, 2018	CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips...	Abnormally high INR test results with the affected CoaguChek test strips	Class I	Roche Diagnostics Corporation
Sep 12, 2018	EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used t...	Potential ability to leak once used for compounding.	Class II	Baxter Healthcare Corporation
Sep 12, 2018	Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Pro...	The firm received complaints related to the locking mechanism on the steerable inserter not funct...	Class II	Howmedica Osteonics Corp.
Sep 12, 2018	Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1...	Foreign material in product	Class II	CMP Industries, Llc
Sep 12, 2018	EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to...	Potential ability to leak once used for compounding.	Class II	Baxter Healthcare Corporation
Sep 12, 2018	EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to...	Potential ability to leak once used for compounding.	Class II	Baxter Healthcare Corporation
Sep 12, 2018	EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to...	Potential ability to leak once used for compounding.	Class II	Baxter Healthcare Corporation
Sep 12, 2018	EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to ...	Potential ability to leak once used for compounding.	Class II	Baxter Healthcare Corporation
Sep 12, 2018	IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml...	Foreign material in product	Class II	CMP Industries, Llc
Sep 12, 2018	3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 ...	The product inside the package does not match the label. The product was labeled as long thread ...	Class II	Synthes (USA) Products LLC
Sep 11, 2018	B105/125 Patient Monitor. The device is a portable multiparameter unit to ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, ...	The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.	Class II	TiSport, Llc
Sep 11, 2018	PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, RE...	The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D...	Class III	R & D Systems, Inc.
Sep 10, 2018	VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Sci...	There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber sti...	Class II	Boston Scientific Corporation
Sep 10, 2018	-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) ...	Firm identified an issue in the manufacturing process which might contribute to elevated rates of...	Class II	BioFire Diagnostics, LLC
Sep 10, 2018	ESSENTIO Pacemaker	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	ACCOLADE Pacemaker	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision ...	Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion ...	Class II	GE Healthcare Biosciences
Sep 10, 2018	PROPONENT Pacemaker	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm...	Potential for outer pouch sterile barrier to be compromised	Class II	Howmedica Osteonics Corp.

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.