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
Oct 30, 2019	Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943	The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto...	Class II	Medtronic Navigation, Inc.
Oct 30, 2019	HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usa...	The tracheal and brochial swivel connectors are incorrectly labeled.	Class II	Teleflex Medical
Oct 30, 2019	Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108	The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto...	Class II	Medtronic Navigation, Inc.
Oct 30, 2019	XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ;...	Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be pr...	Class II	Allergan PLC
Oct 30, 2019	Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each...	Product shelf life may be shorter than that indicated on the label.	Class II	Young Dental Manufacturing Co, LLC
Oct 30, 2019	Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517	The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto...	Class II	Medtronic Navigation, Inc.
Oct 29, 2019	HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 170...	Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)	Class II	Bio-Signal Group Corp.
Oct 29, 2019	HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconduct...	Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)	Class II	Bio-Signal Group Corp.
Oct 28, 2019	Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua...	Class II	Cardinal Health 200, LLC
Oct 28, 2019	Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightwei...	There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially ...	Class I	Smiths Medical ASD Inc.
Oct 28, 2019	Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua...	Class II	Cardinal Health 200, LLC
Oct 28, 2019	iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375,...	Customers have reported incidents where two sets of results report the same Specimen Identifier (...	Class II	Beckman Coulter Inc.
Oct 28, 2019	Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua...	Class II	Cardinal Health 200, LLC
Oct 28, 2019	Genius 2 Tympanic Thermometer Private Label Item Code: 3069	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua...	Class II	Cardinal Health 200, LLC
Oct 28, 2019	Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM anti...	Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneo...	Class II	Roche Diagnostics Operations, Inc.
Oct 28, 2019	Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua...	Class II	Cardinal Health 200, LLC
Oct 28, 2019	iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-71...	Customers have reported incidents where two sets of results report the same Specimen Identifier (...	Class II	Beckman Coulter Inc.
Oct 25, 2019	Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic ma...	Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo...	Class II	Zimmer Biomet, Inc.
Oct 25, 2019	Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manua...	Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo...	Class II	Zimmer Biomet, Inc.
Oct 25, 2019	iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Produc...	Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.	Class II	Conformis, Inc.
Oct 25, 2019	Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobi...	Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues w...	Class II	Galil Medical, Inc.
Oct 25, 2019	BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core nee...	During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Bi...	Class II	Bard Peripheral Vascular Inc
Oct 24, 2019	Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H69...	The firm has received reports of tip separation during usage of the catheters, which may expose ...	Class I	Applied Medical Resources Corp
Oct 24, 2019	Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic...	The firm has received reports of tip separation during usage of the catheters, which may expose ...	Class I	Applied Medical Resources Corp
Oct 24, 2019	Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. P...	Certain dilation and extension catheters are being recalled because these catheters may have miss...	Class II	Boston Scientific Corporation
Oct 24, 2019	Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, ...	Certain dilation and extension catheters are being recalled because these catheters may have miss...	Class II	Boston Scientific Corporation
Oct 24, 2019	Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Pack...	Certain dilation and extension catheters are being recalled because these catheters may have miss...	Class II	Boston Scientific Corporation
Oct 24, 2019	NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide...	Certain dilation and extension catheters are being recalled because these catheters may have miss...	Class II	Boston Scientific Corporation
Oct 24, 2019	Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT...	Sterile packaging incomplete seals may compromise sterility of the product	Class II	Centurion Medical Products Corporation
Oct 24, 2019	Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)0060...	The firm has received reports of tip separation during usage of the catheters, which may expose ...	Class I	Applied Medical Resources Corp
Oct 23, 2019	GENTLEWAVE REF: FG-002-0001	The console would continue to run for extended period when the foot pedal was released.	Class II	Sonendo Inc
Oct 23, 2019	Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnos...	Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed int...	Class II	Abbott GmBH & Co. KG
Oct 22, 2019	BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation	Following Customers complaints, investigations have been initiated on potentially false results o...	Class II	Biomerieux Inc
Oct 22, 2019	Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 ...	Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (P...	Class II	Steris Corporation
Oct 22, 2019	EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026...	The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking d...	Class II	Encore Medical, LP
Oct 22, 2019	EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vente...	Their is a possibility that the cannula may separate from its connector, potentially causing a br...	Class II	Edwards Lifesciences, LLC
Oct 22, 2019	Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam	The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain ...	Class II	Steris Corporation
Oct 21, 2019	MicroScan WalkAway-96 plus Instrument REF B1018-284	WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi...	Class II	Beckman Coulter Inc.
Oct 21, 2019	MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R	WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi...	Class II	Beckman Coulter Inc.
Oct 21, 2019	MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R	WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi...	Class II	Beckman Coulter Inc.
Oct 21, 2019	JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory c...	Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1...	Class II	Haemonetics Corporation
Oct 21, 2019	JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory c...	Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1...	Class II	Haemonetics Corporation
Oct 21, 2019	JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory com...	Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1...	Class II	Haemonetics Corporation
Oct 21, 2019	High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: i...	Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1...	Class II	Haemonetics Corporation
Oct 21, 2019	CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its r...	Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1...	Class II	Haemonetics Corporation
Oct 21, 2019	CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: it...	Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1...	Class II	Haemonetics Corporation
Oct 21, 2019	Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory compon...	Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1...	Class II	Haemonetics Corporation
Oct 21, 2019	JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory compone...	Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1...	Class II	Haemonetics Corporation
Oct 21, 2019	CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: it...	Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1...	Class II	Haemonetics Corporation
Oct 21, 2019	Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph...	The potential compromise of the sterility of products from an undersealed chevron in the packagin...	Class II	Cook 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.