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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 461 of 1191

FDA device recalls, page 461 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2563-2018	Class II	Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,	Galt Medical Corp	KGZ	2018-05-02
Z-2562-2018	Class II	Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d)...	Galt Medical Corp	DYB	2018-05-02
Z-2561-2018	Class II	1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10...	Galt Medical Corp	DRE	2018-05-02
Z-2560-2018	Class II	1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b)...	Galt Medical Corp	KGZ	2018-05-02
Z-2559-2018	Class II	1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile...	Galt Medical Corp	DYB	2018-05-02
Z-2558-2018	Class II	1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a)...	Galt Medical Corp	DYB	2018-05-02
Z-1956-2018	Class II	MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a...	Roche Molecular Systems Inc	JJH	2018-05-02
Z-2314-2018	Class II	Artis zeego, Material no. 10280959 , for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2313-2018	Class II	Artis zee MP, Material no. 10094139, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2312-2018	Class II	Artis zee floor MN, Material no. 10094142, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2311-2018	Class II	Artis zee floor, Material no. 10094135, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2310-2018	Class II	Artis zee ceiling, Material no. 10094137, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2309-2018	Class II	Artis zee biplane MN, Material no. 10094143, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2308-2018	Class II	Artis zee biplane, Material no. 10094141, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2307-2018	Class II	Artis Q.zen floor, Material no. 10848353, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2306-2018	Class II	Artis Q.zeego, Material no. 10848283, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2305-2018	Class II	Artis Q.zen biplane, Material no. 10848355, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2304-2018	Class II	Artis Q ceiling, Material no. 10848281, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2303-2018	Class II	Artis Q biplane, Material no. 10848282, for angiography and whole body...	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2283-2018	Class II	ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000	Siemens Medical Solutions USA, Inc.	OWB	2018-05-01
Z-2301-2018	Class II	OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859...	Philips Medical Systems Nederland B.V.	OWB	2018-05-01
Z-2300-2018	Class II	OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026...	Philips Medical Systems Nederland B.V.	JAA	2018-05-01
Z-2162-2018	Class II	Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are...	Keystone Dental Inc.	DZE	2018-05-01
Z-2052-2018	Class II	Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a...	Hobbs Medical, Inc.	FDX	2018-05-01
Z-1795-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1794-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1793-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1792-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1791-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1790-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1789-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1788-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1787-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1786-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1785-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1784-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-1783-2018	Class II	Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class...	TP Orthodontics, Inc.	ECO	2018-05-01
Z-3186-2018	Class II	PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST NTproBNP is a product for...	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	NBC	2018-04-30
Z-3185-2018	Class II	PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a...	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	JHX	2018-04-30
Z-2144-2018	Class II	IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146	Philips North America LLC	DSI	2018-04-30
Z-2143-2018	Class II	IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352	Philips North America LLC	DSI	2018-04-30
Z-2142-2018	Class II	IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351	Philips North America LLC	DSI	2018-04-30
Z-2141-2018	Class II	IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350	Philips North America LLC	DSI	2018-04-30
Z-2873-2018	Class II	GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and...	GE Healthcare Japan Corporation	JAK	2018-04-27
Z-2872-2018	Class II	GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and...	GE Healthcare Japan Corporation	JAK	2018-04-27
Z-2871-2018	Class II	GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA...	GE Healthcare Japan Corporation	JAK	2018-04-27
Z-2870-2018	Class II	GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are...	GE Healthcare Japan Corporation	JAK	2018-04-27
Z-2408-2018	Class II	Ankle Arthrodesis Nail, right T2 Ankle 11x300mm, Product Number 18191130S	Stryker Corp.	HSB	2018-04-27
Z-2407-2018	Class II	Ankle Arthrodesis Nail, right T2 Ankle 10x300mm, Product Number 18191030S	Stryker Corp.	HSB	2018-04-27
Z-2406-2018	Class II	Femoral Nail, RIGHT T2 GTN 14x460 mm, Product Number 18511446S	Stryker Corp.	HSB	2018-04-27