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 407 of 1190

FDA device recalls, page 407 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1285-2019	Class II	ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus...	Medtronic, Inc.	LZA	2019-03-22
Z-1284-2019	Class II	ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy...	Medtronic, Inc.	LZA	2019-03-22
Z-1283-2019	Class II	ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy...	Medtronic, Inc.	LZA	2019-03-22
Z-1716-2019	Class II	Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.	Flowonix Medical Inc	LKK	2019-03-21
Z-1715-2019	Class II	Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.	Flowonix Medical Inc	LKK	2019-03-21
Z-1714-2019	Class II	Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.	Flowonix Medical Inc	LKK	2019-03-21
Z-0166-2020	Class II	Rifton E-Pacer, SKU K660, powered lift device	Community Products, LLC	FSA	2019-03-21
Z-0165-2020	Class II	Rifton TRAM Low Base, SKU K320, powered lift device	Community Products, LLC	FSA	2019-03-21
Z-0164-2020	Class II	Rifton TRAM Standard Base, SKU K310, powered lift device	Community Products, LLC	FSA	2019-03-21
Z-1713-2019	Class II	Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with...	Flowonix Medical Inc	LKK	2019-03-21
Z-1712-2019	Class II	Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828...	Flowonix Medical Inc	LKK	2019-03-21
Z-1113-2019	Class II	syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT...	Siemens Medical Solutions USA, Inc.	JAK	2019-03-21
Z-1112-2019	Class II	syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT...	Siemens Medical Solutions USA, Inc.	JAK	2019-03-21
Z-2221-2019	Class II	Regard custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker...	Resource Optimization & Innovation, LLC	KDD	2019-03-21
Z-2220-2019	Class II	Regard custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled...	Resource Optimization & Innovation, LLC	KDD	2019-03-21
Z-1309-2019	Class II	ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number...	ConMed Corporation	GCJ	2019-03-21
Z-1308-2019	Class II	ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8...	ConMed Corporation	GCJ	2019-03-21
Z-1307-2019	Class II	ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number...	ConMed Corporation	GCJ	2019-03-21
Z-1306-2019	Class II	ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2...	ConMed Corporation	GCJ	2019-03-21
Z-1305-2019	Class II	ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2...	ConMed Corporation	GCJ	2019-03-21
Z-1304-2019	Class II	ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2...	ConMed Corporation	GCJ	2019-03-21
Z-1193-2019	Class I	EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A...	Edwards Lifesciences LLC	DXN	2019-03-21
Z-1204-2019	Class II	Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus...	Siemens Medical Solutions USA, Inc.	IYE	2019-03-20
Z-1266-2019	Class II	Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General...	GE Healthcare	JAK	2019-03-20
Z-1265-2019	Class II	NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool...	GE Healthcare	JAK	2019-03-20
Z-1264-2019	Class II	NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670...	GE Healthcare	JAK	2019-03-20
Z-1263-2019	Class II	NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear...	GE Healthcare	JAK	2019-03-20
Z-1262-2019	Class II	NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear...	GE Healthcare	JAK	2019-03-20
Z-1261-2019	Class II	NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear...	GE Healthcare	JAK	2019-03-20
Z-1260-2019	Class II	Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical...	GE Healthcare	JAK	2019-03-20
Z-1259-2019	Class II	Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical...	GE Healthcare	JAK	2019-03-20
Z-1258-2019	Class II	Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery...	GE Healthcare	JAK	2019-03-20
Z-1257-2019	Class II	Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector...	GE Healthcare	JAK	2019-03-20
Z-1364-2019	Class II	VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product...	Ortho-Clinical Diagnostics, Inc.	JJE	2019-03-20
Z-1221-2019	Class III	Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF...	Getinge US Sales LLC	PIF	2019-03-20
Z-0062-2020	Class II	AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696...	GE Healthcare	MOS	2019-03-19
Z-1389-2019	Class II	Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520...	Collagen Matrix, Inc	NPL	2019-03-19
Z-1215-2019	Class II	Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The...	Stryker Corp.	GFA	2019-03-19
Z-1207-2019	Class II	OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566...	Eastman Kodak Company	JAK	2019-03-19
Z-1190-2019	Class III	BIOPHEN LMWH Control C4, REF 224201	Aniara Diagnostica LLC	GGN	2019-03-19
Z-1189-2019	Class III	BIOPHEN UFH Control C1, REF 224101	Aniara Diagnostica LLC	GGN	2019-03-19
Z-1188-2019	Class III	BIOPHEN UFH Control C2, REF 223901	Aniara Diagnostica LLC	GGN	2019-03-19
Z-1259-2020	Class III	HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF...	Advanced Bionics LLC	MCM	2019-03-18
Z-2219-2019	Class II	IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes...	Ideal Implant Incorporated	FWM	2019-03-18
Z-1328-2019	Class II	CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA...	Opgen Inc	LJG	2019-03-18
Z-1298-2019	Class II	Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is...	Siemens Medical Solutions USA, Inc.	OWB	2019-03-18
Z-1251-2019	Class II	MRIdian Linac Radiation Therapy System, Model 20000.	Viewray, Inc.	IYE	2019-03-18
Z-1194-2019	Class II	Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative...	Roche Diagnostics GmbH	CJW	2019-03-18
Z-1461-2020	Class II	Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as...	Response Biomedical Corp.	JJY	2019-03-15
Z-2752-2019	Class I	SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5 SH, .070", REF SA6JR45SH. for...	Medtronic, Inc.	DQY	2019-03-15