Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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Date	Product	Reason	Class	Firm
Dec 11, 2019	Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitor...	Inability to dose the test strips, may result in a temporary inability to get a result that could...	Class II	Roche Diabetes Care, Inc.
Dec 11, 2019	Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY	Incomplete seals on the sterile package may compromise the sterility	Class II	Centurion Medical Products Corporation
Dec 11, 2019	Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10...	Incomplete seals on the sterile package may compromise the sterility	Class II	Centurion Medical Products Corporation
Dec 11, 2019	Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY	Incomplete seals on the sterile package may compromise the sterility	Class II	Centurion Medical Products Corporation
Dec 11, 2019	Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY	Incomplete seals on the sterile package may compromise the sterility	Class II	Centurion Medical Products Corporation
Dec 11, 2019	Centurion- ENT SNUF3 SNUFFER KIT Y	Incomplete seals on the sterile package may compromise the sterility	Class II	Centurion Medical Products Corporation
Dec 11, 2019	Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT U...	Incomplete seals on the sterile package may compromise the sterility	Class II	Centurion Medical Products Corporation
Dec 11, 2019	Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monit...	Inability to dose the test strips, may result in a temporary inability to get a result that could...	Class II	Roche Diabetes Care, Inc.
Dec 10, 2019	VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit	Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which ...	Class II	bioMerieux, Inc.
Dec 9, 2019	BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Cont...	The gas spring on the front and rear protective cover may fail. There is a low risk of injury to...	Class II	Mindray DS USA, Inc. dba Mindray North America
Dec 9, 2019	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 40...	Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths ins...	Class II	Abbott Medical
Dec 9, 2019	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303	Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of ...	Class II	Abbott Medical
Dec 9, 2019	ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ...	The gas spring on the front and rear protective cover may fail. There is a low risk of injury to...	Class II	Mindray DS USA, Inc. dba Mindray North America
Dec 6, 2019	Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH	Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Ca...	Class II	Arrow International Inc
Dec 6, 2019	Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following R...	The firm has become aware that there is a potential that the glass cover at the distal end of the...	Class II	Karl Storz Endoscopy
Dec 5, 2019	Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instrum...	Instrument can break at the level of the thread when being exposed to high forces during nail imp...	Class II	Stryker GmbH
Dec 5, 2019	Mazor X Surgical System Positioner Type II, REF: ASM0214-02	There is a potential for the surgical system to detach from the operational room table unexpected...	Class II	Medtronic Navigation, Inc.
Dec 4, 2019	0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 1141...	The stiffness of the soft end of the guidewire caused tissue perforation.	Class I	Argon Medical Devices, Inc
Dec 4, 2019	0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114...	The stiffness of the soft end of the guidewire caused tissue perforation.	Class I	Argon Medical Devices, Inc
Dec 3, 2019	Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer	An issue with the Lunar iDXA control panel may cause the start button to not release and potentia...	Class II	GE Healthcare, LLC
Dec 3, 2019	Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, ...	Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased pos...	Class II	Johnson & Johnson Surgical Vision Inc
Dec 3, 2019	Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer	An issue with the Lunar iDXA control panel may cause the start button to not release and potentia...	Class II	GE Healthcare, LLC
Dec 3, 2019	Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, RE...	Labels with incorrect translations were identified by Exactech is a distributor in the Netherland...	Class II	Exactech, Inc.
Dec 3, 2019	Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, R...	Labels with incorrect translations were identified by Exactech is a distributor in the Netherland...	Class II	Exactech, Inc.
Dec 3, 2019	Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer	An issue with the Lunar iDXA control panel may cause the start button to not release and potentia...	Class II	GE Healthcare, LLC
Dec 3, 2019	Lunar iDXA bone densitometer	An issue with the Lunar iDXA control panel may cause the start button to not release and potentia...	Class II	GE Healthcare, LLC
Dec 3, 2019	Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. ...	A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.	Class II	Maquet Cardiovascular Us Sales, Llc
Dec 2, 2019	PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006	The boxes used by the shipper were not validated for use during transport.	Class II	3-D Matrix, Inc.
Dec 2, 2019	Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with...	One brand of batteries have a small dimensional difference in the negative button terminal, which...	Class II	Polymer Technology Systems, Inc.
Dec 2, 2019	PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, ...	One brand of batteries have a small dimensional difference in the negative button terminal, which...	Class II	Polymer Technology Systems, Inc.
Dec 2, 2019	BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial...	Incorrect product labeling.	Class II	Argon Medical Devices, Inc
Dec 2, 2019	Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036	One brand of batteries have a small dimensional difference in the negative button terminal, which...	Class II	Polymer Technology Systems, Inc.
Dec 2, 2019	Medical convenience trays and kits, labeled as: Medical Action Industries,...	The kits contain a bottle of saline solution which may exceed the USP specified pH requirements o...	Class II	Medical Action Industries, Inc. 306
Dec 2, 2019	Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The I...	Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.	Class II	Medela Inc
Dec 2, 2019	Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number:...	Temperature deviation did not meet release specifications	Class II	Degania Silicone, Ltd.
Dec 2, 2019	HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 1...	Excessive static electricity can potentially cause unrecoverable power loss and damage to the mob...	Class II	Thoratec Corp.
Dec 2, 2019	PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, w...	One brand of batteries have a small dimensional difference in the negative button terminal, which...	Class II	Polymer Technology Systems, Inc.
Nov 28, 2019	aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00	The company has become aware that the soft tissue retractor is not always removed during the sawi...	Class II	AAP Implantate Ag
Nov 27, 2019	BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only,...	The firm has received reports that the spring/washer/bearing components in the block of the laryn...	Class II	Flexicare Medical Ltd.
Nov 27, 2019	QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI:...	If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during e...	Class II	Edwards Lifesciences, LLC
Nov 27, 2019	BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do ...	The firm has received reports that the spring/washer/bearing components in the block of the laryn...	Class II	Flexicare Medical Ltd.
Nov 27, 2019	BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Onl...	The firm has received reports that the spring/washer/bearing components in the block of the laryn...	Class II	Flexicare Medical Ltd.
Nov 27, 2019	BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not...	The firm has received reports that the spring/washer/bearing components in the block of the laryn...	Class II	Flexicare Medical Ltd.
Nov 26, 2019	iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgica...	There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue...	Class II	Deerfield Imaging, Inc.
Nov 25, 2019	Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended...	GE Healthcare has become aware that there is a potential for a loose cable connection inside spec...	Class I	GE Healthcare, LLC
Nov 25, 2019	Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X...	During a routine inspection of a system, a crack on the C-arm holder was discovered. In the even...	Class II	Siemens Medical Solutions USA, Inc
Nov 25, 2019	Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended...	GE Healthcare has become aware that there is a potential for a loose cable connection inside spec...	Class I	GE Healthcare, LLC
Nov 25, 2019	VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usag...	The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. ...	Class II	Greiner Bio-One North America, Inc.
Nov 25, 2019	bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an ele...	The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic hig...	Class II	Vyaire Medical
Nov 24, 2019	Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers ...	The devices may be missing the implant coil.	Class II	Microvention, 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.