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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 317 of 1190

FDA device recalls, page 317 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0399-2021	Class I	Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide...	Cook Incorporated	DQX	2020-10-22
Z-0469-2021	Class II	Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic...	Siemens Medical Solutions USA, Inc.	OWB	2020-10-21
Z-0468-2021	Class II	Strauss 25 Carbide Dental Burs (100057XXV)	Coltene /Whaledent AG	EJL	2020-10-20
Z-0467-2021	Class II	CEI Cutting Edge Instruments (PTC-57C)	Coltene /Whaledent AG	EJL	2020-10-20
Z-0466-2021	Class II	Clinic Pack 100 Pieces FG 57 100057C (100057C)	Coltene /Whaledent AG	EJL	2020-10-20
Z-0465-2021	Class II	Fg 57 100057X (100057X)	Coltene /Whaledent AG	EJL	2020-10-20
Z-0464-2021	Class II	Alpen Clinic 100 Carbide Instruments (R100057C)	Coltene /Whaledent AG	EJL	2020-10-20
Z-0482-2021	Class II	ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3...	Viewray, Inc.	IYE	2020-10-20
Z-0481-2021	Class II	ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3...	Viewray, Inc.	IYE	2020-10-20
Z-0485-2021	Class II	MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to...	Mevion Medical Systems, Inc.	LHN	2020-10-19
Z-0492-2021	Class II	Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of...	Geistlich Pharma North America, Inc	NPM	2020-10-19
Z-0491-2021	Class II	Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of...	Geistlich Pharma North America, Inc	NPM	2020-10-19
Z-0490-2021	Class II	Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of...	Geistlich Pharma North America, Inc	NPM	2020-10-19
Z-0569-2021	Class II	DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in...	Ra Medical Systems,Inc	PDU	2020-10-16
Z-0431-2021	Class II	Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use...	Stryker Corp.	HBF	2020-10-16
Z-0507-2021	Class II	Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for...	OLYMPUS Corporation of the Americas	FDF	2020-10-16
Z-0506-2021	Class II	Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for...	OLYMPUS Corporation of the Americas	ODG	2020-10-16
Z-0505-2021	Class II	Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for...	OLYMPUS Corporation of the Americas	ODG	2020-10-16
Z-0504-2021	Class II	Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic...	OLYMPUS Corporation of the Americas	ODG	2020-10-16
Z-0503-2021	Class II	Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an...	OLYMPUS Corporation of the Americas	FDS	2020-10-16
Z-0502-2021	Class II	Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an...	OLYMPUS Corporation of the Americas	FDS	2020-10-16
Z-0501-2021	Class II	Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other...	OLYMPUS Corporation of the Americas	ODG	2020-10-16
Z-0500-2021	Class II	Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an...	OLYMPUS Corporation of the Americas	IYN	2020-10-16
Z-0499-2021	Class II	Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with...	OLYMPUS Corporation of the Americas	ITX	2020-10-16
Z-0471-2021	Class III	VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS...	Ortho-Clinical Diagnostics, Inc.	JJY	2020-10-16
Z-0498-2021	Class II	Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with...	OLYMPUS Corporation of the Americas	ITX	2020-10-16
Z-0425-2021	Class II	Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient...	Medtronic, Inc.	CBK	2020-10-16
Z-0540-2021	Class II	CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector	Halyard Health	KNT	2020-10-16
Z-0418-2021	Class II	Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction...	Boston Scientific Corporation	DQR	2020-10-14
Z-0477-2021	Class II	Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay...	Luminex Corporation	PEN	2020-10-13
Z-0476-2021	Class II	Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay...	Luminex Corporation	PAM	2020-10-13
Z-0496-2021	Class II	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX...	Medtronic, Inc. (Minneapolis, MN 55447)	OCL	2020-10-12
Z-0495-2021	Class II	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX...	Medtronic, Inc. (Minneapolis, MN 55447)	OCL	2020-10-12
Z-0494-2021	Class II	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX...	Medtronic, Inc. (Minneapolis, MN 55447)	OCL	2020-10-12
Z-0493-2021	Class II	Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX...	Medtronic, Inc. (Minneapolis, MN 55447)	OCL	2020-10-12
Z-0524-2021	Class II	Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and...	ROi CPS LLC	MLS	2020-10-12
Z-0512-2021	Class III	Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the...	Talladium Inc	EBG	2020-10-09
Z-0461-2021	Class II	cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions...	Roche Diagnostics GmbH	JQP	2020-10-09
Z-0321-2021	Class II	Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation	Trinity Biotech (Primus Corporation dba Trinity Biotech)	GKA	2020-10-09
Z-0581-2022	Class III	KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)	Microbiologics, Inc.	JTR	2020-10-08
Z-0590-2021	Class II	InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively...	Enterix, Inc.	KHE	2020-10-08
Z-0478-2021	Class II	RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9...	RaySearch Laboratories AB (publ)	MUJ	2020-10-08
Z-0463-2021	Class II	MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar...	Medicrea International	OWI	2020-10-08
Z-0532-2021	Class II	CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional...	Canon Medical Systems USA, Inc.	OWB	2020-10-08
Z-0304-2021	Class II	Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating...	Microbiologics, Inc.	JTR	2020-10-08
Z-0303-2021	Class II	Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating...	Microbiologics, Inc.	JTR	2020-10-08
Z-0302-2021	Class II	Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating...	Microbiologics, Inc.	JTR	2020-10-08
Z-0402-2021	Class II	Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended...	Microbiologics, Inc.	JTR	2020-10-08
Z-0458-2021	Class III	Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid...	STERIS Corporation	FEB	2020-10-07
Z-0460-2021	Class II	Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium	Exactech, Inc.	KWS	2020-10-06