Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 495 of 1191

FDA device recalls, page 495 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0091-2018	Class II	AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman...	Siemens Healthcare Diagnostics Inc.	OYE	2017-10-02
Z-0270-2019	Class III	Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro...	Ameditech, Inc.	NGG	2017-09-30
Z-0927-2018	Class II	O-arm O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The...	Medtronic Navigation, Inc	OWB	2017-09-30
Z-1010-2018	Class II	NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This...	Fresenius Medical Care Renal Therapies Group, LLC	KPO	2017-09-29
Z-0674-2018	Class II	Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number...	Zimmer GmbH	JWH	2017-09-29
Z-0673-2018	Class II	Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number...	Zimmer GmbH	JWH	2017-09-29
Z-0398-2018	Class II	OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are...	The Anspach Effort, Inc.	HWE	2017-09-29
Z-0166-2018	Class II	Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.	Abbott Medical	JJE	2017-09-29
Z-0488-2018	Class II	BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM)...	C.R. Bard Inc	EXS	2017-09-29
Z-0165-2018	Class II	ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000...	Abbott Medical	JJE	2017-09-29
Z-0602-2019	Class II	AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an...	Tosoh Bioscience Inc	KHO	2017-09-28
Z-1352-2018	Class II	Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply...	Magstim Inc.	OBP	2017-09-28
Z-0711-2018	Class II	Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers...	Siemens Medical Solutions USA, Inc.	OWB	2017-09-28
Z-0710-2018	Class II	Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch...	Siemens Medical Solutions USA, Inc.	OWB	2017-09-28
Z-0709-2018	Class II	Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch...	Siemens Medical Solutions USA, Inc.	OWB	2017-09-28
Z-0772-2018	Class II	V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)	STERIS Corporation	MLR	2017-09-28
Z-0278-2018	Class II	Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator	Philips North America LLC	MSX	2017-09-28
Z-0741-2018	Class II	Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock...	Cosmedent, Inc.	KLE	2017-09-28
Z-0076-2018	Class II	FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a...	LivaNova USA, Inc.	DWF	2017-09-28
Z-0090-2018	Class II	Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL...	WalkMed Technologies, LLC	FRN	2017-09-27
Z-1207-2018	Class I	6F Taiga Guiding Catheter	Medtronic, Inc.	DQY	2017-09-26
Z-0694-2018	Class II	Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No...	Integra LifeSciences Corporation	LFL	2017-09-26
Z-0715-2018	Class II	AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be...	Brainlab, Inc.	JAK	2017-09-26
Z-1220-2018	Class III	AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative...	Wallac Oy	JNO	2017-09-25
Z-0169-2018	Class II	Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended...	Resource Optimization & Innovation, LLC	LRO	2017-09-25
Z-0062-2018	Class II	CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented...	Abbott Medical	FRN	2017-09-25
Z-0061-2018	Class II	CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper...	Abbott Medical	FRN	2017-09-25
Z-0060-2018	Class II	CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper...	Abbott Medical	FRN	2017-09-25
Z-0838-2019	Class II	PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of...	Leica Microsystems, Inc.	HRM	2017-09-25
Z-0048-2018	Class II	GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is...	W. L. Gore & Associates, Inc.	MIH	2017-09-25
Z-1217-2019	Class II	Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage...	Guangzhou Improve Medical Instruments Co., Ltd.	FMI	2017-09-22
Z-2549-2018	Class II	Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO	Guangzhou Improve Medical Instruments Co., Ltd.	FMI	2017-09-22
Z-1171-2018	Class II	**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood...	Circulatory Technology, Inc.	DTN	2017-09-22
Z-0817-2018	Class II	Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile...	Circulatory Technology, Inc.	DTN	2017-09-22
Z-0742-2018	Class II	Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB...	Boston Scientific Corporation	DQO	2017-09-22
Z-0915-2018	Class II	VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic	Ortho-Clinical Diagnostics, Inc.	DIF	2017-09-22
Z-0914-2018	Class II	VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic	Ortho-Clinical Diagnostics, Inc.	DIF	2017-09-22
Z-0913-2018	Class II	VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic	Ortho-Clinical Diagnostics, Inc.	DIF	2017-09-22
Z-0912-2018	Class II	VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic	Ortho-Clinical Diagnostics, Inc.	DIF	2017-09-22
Z-0911-2018	Class II	VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic	Ortho-Clinical Diagnostics, Inc.	DIF	2017-09-22
Z-0898-2018	Class II	Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used...	Boston Scientific Corporation	GEX	2017-09-22
Z-0897-2018	Class II	Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in...	Boston Scientific Corporation	GEX	2017-09-22
Z-0044-2018	Class II	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm...	Bard Peripheral Vascular Inc	KNW	2017-09-22
Z-0640-2018	Class II	GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning...	Medtronic, Inc.	KNT	2017-09-21
Z-0809-2018	Class II	proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt...	Aesculap Inc	JXG	2017-09-21
Z-0537-2018	Class III	Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122...	Medtronic Neuromodulation	LKK	2017-09-21
Z-1145-2018	Class II	Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal...	Merit Medical Systems, Inc.	OJV	2017-09-20
Z-1144-2018	Class II	Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck Classic Peritoneal...	Merit Medical Systems, Inc.	OJV	2017-09-20
Z-1143-2018	Class II	Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B	Merit Medical Systems, Inc.	FJS	2017-09-20
Z-0268-2018	Class III	Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare...	Philips North America LLC	MHX	2017-09-20