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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 540 of 1191

FDA device recalls, page 540 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1437-2017	Class II	MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded...	Siemens Medical Solutions USA, Inc.	IYE	2017-01-25
Z-1436-2017	Class II	MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended...	Siemens Medical Solutions USA, Inc.	IYE	2017-01-25
Z-1435-2017	Class II	MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS...	Siemens Medical Solutions USA, Inc.	IYE	2017-01-25
Z-1434-2017	Class II	MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS...	Siemens Medical Solutions USA, Inc.	IYE	2017-01-25
Z-1433-2017	Class II	MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded...	Siemens Medical Solutions USA, Inc.	IYE	2017-01-25
Z-1432-2017	Class II	PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended...	Siemens Medical Solutions USA, Inc.	IYE	2017-01-25
Z-1215-2017	Class II	PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use...	Siemens Medical Solutions USA, Inc.	IYE	2017-01-25
Z-1214-2017	Class II	ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle...	Siemens Medical Solutions USA, Inc.	IYE	2017-01-25
Z-1213-2017	Class II	ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The...	Siemens Medical Solutions USA, Inc.	IYE	2017-01-25
Z-1212-2017	Class II	ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The...	Siemens Medical Solutions USA, Inc.	IYE	2017-01-25
Z-1410-2017	Class III	The UNI-CP System; Model Number: 330230SND.	Integra LifeSciences Corporation	JDR	2017-01-25
Z-1248-2017	Class III	SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.	DeRoyal Industries, Inc.	LRO	2017-01-25
Z-1247-2017	Class III	DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.	DeRoyal Industries, Inc.	LRO	2017-01-25
Z-1382-2017	Class II	OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay...	MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA	KKY	2017-01-25
Z-1231-2017	Class II	Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each...	Ortho-Clinical Diagnostics, Inc.	OCC	2017-01-25
Z-0289-2021	Class II	Merge LIS	Merge Healthcare Incorporated	NSX	2017-01-23
Z-1455-2017	Class II	XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB...	Strata Skin Sciences, Inc.	GEX	2017-01-23
Z-1441-2017	Class II	RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in...	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQV	2017-01-23
Z-1409-2017	Class II	Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere...	Medtronic, Inc.	MMP	2017-01-23
Z-1408-2017	Class II	Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X...	Medtronic, Inc.	MMP	2017-01-23
Z-0606-2018	Class II	Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended...	Microbiologics, Inc.	LSI	2017-01-20
Z-1188-2017	Class II	Discovery MR450 The systems are whole body magnetic resonance scanners designed to...	GE Healthcare	LNH	2017-01-20
Z-1402-2017	Class II	CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra...	Metrex Research	LRJ	2017-01-20
Z-1192-2017	Class II	Integra Cadence Total Ankle System	Integra LifeSciences Corporation	HSN	2017-01-20
Z-1222-2017	Class II	Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010	Atrium Medical Corporation	GBZ	2017-01-20
Z-1221-2017	Class II	Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008	Atrium Medical Corporation	GBZ	2017-01-20
Z-1224-2017	Class III	AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal...	Applied Medical Technology Inc	KNT	2017-01-19
Z-1199-2017	Class II	6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring...	Acumed LLC	HRS	2017-01-19
Z-1223-2017	Class III	AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI)...	Applied Medical Technology Inc	KNT	2017-01-19
Z-0020-2018	Class II	Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed...	Philips North America LLC	JAK	2017-01-18
Z-0019-2018	Class II	Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed...	Philips North America LLC	JAK	2017-01-18
Z-0018-2018	Class II	Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed...	Philips North America LLC	JAK	2017-01-18
Z-0017-2018	Class II	Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography...	Philips North America LLC	JAK	2017-01-18
Z-0016-2018	Class II	Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography...	Philips North America LLC	JAK	2017-01-18
Z-0015-2018	Class II	Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed...	Philips North America LLC	JAK	2017-01-18
Z-1815-2017	Class II	Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software...	RaySearch Laboratories AB (publ)	MUJ	2017-01-18
Z-1226-2017	Class II	ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a...	bioMerieux, Inc.	JWY	2017-01-18
Z-1196-2017	Class II	HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow...	Argon Medical Devices, Inc	KNW	2017-01-18
Z-1195-2017	Class II	T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4...	Argon Medical Devices, Inc	KNW	2017-01-18
Z-1194-2017	Class II	BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose...	Argon Medical Devices, Inc	KNW	2017-01-18
Z-1232-2019	Class I	ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F	OriGen Biomedical, Inc.	DWF	2017-01-17
Z-1231-2019	Class I	ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F	OriGen Biomedical, Inc.	DWF	2017-01-17
Z-1230-2019	Class I	ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F	OriGen Biomedical, Inc.	DWF	2017-01-17
Z-1229-2019	Class I	ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F	OriGen Biomedical, Inc.	DWF	2017-01-17
Z-1228-2019	Class I	ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F	OriGen Biomedical, Inc.	DWF	2017-01-17
Z-1227-2019	Class I	ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F	OriGen Biomedical, Inc.	DWF	2017-01-17
Z-2713-2017	Class II	Video Duodenoscope These instruments are intended to provide optical visualization of...	PENTAX of America, Inc.	FDT	2017-01-17
Z-1229-2017	Class II	Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central...	Philips North America LLC	MHX	2017-01-17
Z-1121-2017	Class II	Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All...	Medtronic Neurosurgery	JXG	2017-01-17
Z-1189-2017	Class II	BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75...	Becton Dickinson & Co	JKA	2017-01-16