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
Aug 30, 2018	Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers...	Firm received sporadic reports of discoloration on certain lots of the product, which has been id...	Class II	MEDLINE INDUSTRIES INC
Aug 30, 2018	Centricity Universal Viewer with Cross Enterprise Display This impacts produc...	Remote comparison studies displayed may be associated with the wrong patient, without a caution i...	Class II	GE Healthcare, LLC
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, M...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 29, 2018	INSORB SUBCUTICULAR SKIN STAPLER, REF 2030	Possible compromise of the sterile barrier integrity	Class II	Incisive Surgical Inc
Aug 29, 2018	IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software p...	Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) ins...	Class II	Data Innovations, LLC
Aug 29, 2018	Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compres...	The product was designed for 120V usage and is being used in South Africa with 220V. There is a ...	Class II	SANRAI INTERNATIONAL LLC
Aug 28, 2018	Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. P...	The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet...	Class II	Stryker GmbH
Aug 28, 2018	Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardi...	Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board...	Class II	Terumo Cardiovascular Systems Corporation
Aug 28, 2018	Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 14...	Certain HVAD System Controller units may not meet the labeled standard for protection against wat...	Class II	Heartware, Inc.
Aug 28, 2018	Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardi...	Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board...	Class II	Terumo Cardiovascular Systems Corporation
Aug 28, 2018	CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT,...	Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr...	Class I	Alcon Research, LTD.
Aug 28, 2018	CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065...	Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr...	Class I	Alcon Research, LTD.
Aug 28, 2018	Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. ...	The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet...	Class II	Stryker GmbH
Aug 28, 2018	Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The AR...	There is a potential to generate falsely elevated serum or plasma chloride results when using the...	Class II	Abbott Laboratories, Inc
Aug 28, 2018	CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT,...	Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr...	Class I	Alcon Research, LTD.
Aug 28, 2018	Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. ...	The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet...	Class II	Stryker GmbH
Aug 28, 2018	VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number...	The reagent pack exhibits the potential for an increased frequency of calibration failures.	Class II	Ortho-Clinical Diagnostics
Aug 28, 2018	CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF C...	Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr...	Class I	Alcon Research, LTD.
Aug 28, 2018	VidiStar(TM) PACS & DICOM Viewer Software system	The secure filesystem client software used in the interface between the Vidistar PACS and an EHR ...	Class II	Hitachi Healthcare Americas Corp Informatics Di...
Aug 28, 2018	Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. ...	The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet...	Class II	Stryker GmbH
Aug 27, 2018	Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage...	The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete s...	Class II	Arthrex, Inc.
Aug 24, 2018	FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product...	The firm has identified customer sites where there are modules on which the safety pacemaker labe...	Class II	Inpeco S.A.
Aug 24, 2018	Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.	NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assa...	Class II	Beckman Coulter Inc.
Aug 24, 2018	Beckman Coulter Lipase, REF OSR6130 and OSR6230.	NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assa...	Class II	Beckman Coulter Inc.
Aug 24, 2018	TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a compo...	The bone screw is shorter than the intended design specification.	Class II	TriMed Inc.
Aug 24, 2018	Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use	Leaky bottles due to a defect in the bottle cap compromising the sterility of the product	Class II	Life Technologies, Corp.
Aug 24, 2018	Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141	Leaky bottles due to a defect in the bottle cap compromising the sterility of the product	Class II	Life Technologies, Corp.
Aug 24, 2018	TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tra...	Modifications to the specification were not appropriately qualified through the company's design ...	Class II	TriMed Inc.
Aug 24, 2018	Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant...	RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB	Class II	Vision RT Ltd
Aug 24, 2018	Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061	Leaky bottles due to a defect in the bottle cap compromising the sterility of the product	Class II	Life Technologies, Corp.
Aug 24, 2018	Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vi...	Leaky bottles due to a defect in the bottle cap compromising the sterility of the product	Class II	Life Technologies, Corp.
Aug 24, 2018	Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and ...	Defect consists of a small crack in the top end of the barrel near the needle.	Class II	ShinChang Medical Co., Ltd.
Aug 23, 2018	BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Cathete...	One lot of the specified needles is not performing as intended due to a failure in the needle tip...	Class II	Becton Dickinson & Company
Aug 23, 2018	Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Cath...	Electrophysiology catheters were identified to be item # D134903 and distributed. It was subseque...	Class II	Stryker Sustainability Solutions
Aug 23, 2018	AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated...	The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These label...	Class II	Tosoh Bioscience Inc
Aug 22, 2018	Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Mode...	Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped punctur...	Class II	Smiths Medical ASD Inc.
Aug 22, 2018	Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref N...	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.	Class II	Zimmer Biomet, Inc.
Aug 22, 2018	Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogu...	The sterilization process used was unqualified.	Class II	Safe N Simple, LLC
Aug 22, 2018	Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Numbe...	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.	Class II	Zimmer Biomet, Inc.
Aug 22, 2018	Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pac...	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.	Class II	Zimmer Biomet, Inc.
Aug 22, 2018	Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pac...	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.	Class II	Zimmer Biomet, Inc.
Aug 22, 2018	Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref N...	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.	Class II	Zimmer Biomet, Inc.
Aug 22, 2018	Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 1...	The sterilization process used was unqualified.	Class II	Safe N Simple, LLC
Aug 22, 2018	Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pa...	Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.	Class II	Zimmer Biomet, Inc.
Aug 21, 2018	Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, ...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, thr...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - ...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - ...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - ...	There is potential for the plastic optical tip to become detached from the metal shaft.	Class II	Genicon, Inc.
Aug 21, 2018	Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications:...	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca...	Class II	OriGen Biomedical, 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.