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 662 of 1191

FDA device recalls, page 662 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0353-2016	Class II	Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura...	Philips North America LLC	OWB	2015-02-03
Z-0352-2016	Class II	Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper...	Philips North America LLC	OWB	2015-02-03
Z-0351-2016	Class II	Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper...	Philips North America LLC	OWB	2015-02-03
Z-0350-2016	Class II	Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura...	Philips North America LLC	OWB	2015-02-03
Z-0349-2016	Class II	Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura...	Philips North America LLC	OWB	2015-02-03
Z-0348-2016	Class II	Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura...	Philips North America LLC	OWB	2015-02-03
Z-0347-2016	Class II	Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20...	Philips North America LLC	OWB	2015-02-03
Z-1585-2015	Class II	Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A...	FUJIFILM Healthcare Americas Corporation	MUE	2015-02-03
Z-1260-2015	Class II	Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails...	Synthes GmbH	LXH	2015-02-03
Z-1209-2015	Class I	IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number...	Boston Scientific Corporation	OAD	2015-02-03
Z-1213-2015	Class II	Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The...	Norwex USA Inc.	EFW	2015-02-03
Z-0346-2016	Class II	Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper...	Philips North America LLC	OWB	2015-02-03
Z-1241-2015	Class II	LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed...	Howmedica Osteonics Corp	JDI	2015-02-03
Z-1637-2016	Class II	Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial...	Bradshaw Medical Inc.	HXC	2015-02-02
Z-2358-2015	Class II	Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One...	Invacare GmbH	ITI	2015-02-02
Z-1212-2015	Class II	COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological	IBA Dosimetry GmbH	IYE	2015-02-02
Z-1249-2015	Class II	EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE...	Microport Orthopedics Inc.	JWH	2015-02-02
Z-1286-2015	Class II	CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx...	Abbott Medical	FPA	2015-02-02
Z-2069-2015	Class I	Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator...	Western Enterprises, Inc.	CAN	2015-01-31
Z-1358-2015	Class II	Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok...	C.R. Bard Inc	KNX	2015-01-30
Z-1248-2015	Class II	GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in...	GE Healthcare	KPR	2015-01-30
Z-1140-2015	Class II	Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)	Datascope Corp.	DSP	2015-01-30
Z-1306-2015	Class II	Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific...	Penner Patient Care, Inc	MMP	2015-01-30
Z-1238-2015	Class II	Elekta Precise Treatment Table	Elekta Limited	JAI	2015-01-29
Z-1266-2015	Class II	Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee...	Zimmer GmbH	MBH	2015-01-28
Z-1527-2015	Class II	9F Plastic Dual Port; The port systems are totally implantable vascular access devices...	Medical Components, Inc.	LJT	2015-01-28
Z-1145-2015	Class II	Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube...	GE Healthcare	MHX	2015-01-28
Z-1144-2015	Class II	Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare...	GE Healthcare	MHX	2015-01-28
Z-1231-2015	Class II	ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog...	Siemens Healthcare Diagnostics Inc.	JLS	2015-01-27
Z-1230-2015	Class II	ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number...	Siemens Healthcare Diagnostics Inc.	JLS	2015-01-27
Z-1229-2015	Class II	ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number...	Siemens Healthcare Diagnostics Inc.	JLS	2015-01-27
Z-1270-2015	Class II	GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers...	GE Healthcare	CBK	2015-01-27
Z-1301-2015	Class II	NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal...	CooperSurgical, Inc.	IMD	2015-01-26
Z-1300-2015	Class II	MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel...	CooperSurgical, Inc.	IMD	2015-01-26
Z-1299-2015	Class II	Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid...	CooperSurgical, Inc.	IMD	2015-01-26
Z-1298-2015	Class II	CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer...	CooperSurgical, Inc.	IMD	2015-01-26
Z-1130-2015	Class II	Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II...	Haemonetics Corporation	JPA	2015-01-26
Z-1280-2015	Class II	Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and...	Datascope Corp.	MHX	2015-01-23
Z-1265-2015	Class II	MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog...	Southern Implants, (Pty.) Ltd.	DZE	2015-01-23
Z-1374-2015	Class II	Bio-CORE Cannula (Needle) Set	Biologic Therapies, Inc.	FGY	2015-01-23
Z-1373-2015	Class II	Bio-MAC Cannula (Needle) Set	Biologic Therapies, Inc.	FGY	2015-01-23
Z-1372-2015	Class II	Bio-PLASTY Cannula (Needle)	Biologic Therapies, Inc.	FGY	2015-01-23
Z-1251-2015	Class II	Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210...	Philips North America LLC	KPR	2015-01-23
Z-1269-2015	Class II	MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.	Baxter Healthcare Corporation	KDI	2015-01-22
Z-1128-2015	Class II	Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm...	Mako Surgical Corp.	OLO	2015-01-22
Z-1049-2015	Class II	FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD...	Carl Zeiss Meditec Inc	NFJ	2015-01-22
Z-1258-2015	Class II	Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood...	Siemens Healthcare Diagnostics Inc.	JKA	2015-01-22
Z-1257-2015	Class II	Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood...	Siemens Healthcare Diagnostics Inc.	JKA	2015-01-22
Z-1256-2015	Class II	Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood...	Siemens Healthcare Diagnostics Inc.	JKA	2015-01-22
Z-1115-2015	Class II	GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus &...	ZimVie US Corp LLC	NDP	2015-01-22