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 667 of 1191

FDA device recalls, page 667 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1132-2015	Class II	CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem...	Zimmer GmbH	LPH	2014-12-17
Z-1093-2015	Class II	MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB)...	Stryker Craniomaxillofacial Division	FTL	2014-12-17
Z-1092-2015	Class II	MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and...	Stryker Craniomaxillofacial Division	FWP	2014-12-17
Z-1091-2015	Class II	MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block...	Stryker Craniomaxillofacial Division	FWP	2014-12-17
Z-1090-2015	Class II	MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers...	Stryker Craniomaxillofacial Division	FWP	2014-12-17
Z-1012-2015	Class II	Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended...	Aesculap Inc	JXG	2014-12-17
Z-1028-2015	Class III	Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for...	Abbott Medical	JKA	2014-12-17
Z-1315-2015	Class II	Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical...	Leica Microsystems, Inc.	NJT	2014-12-16
Z-0987-2015	Class II	ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific...	Siemens Healthcare Diagnostics Inc.	JQP	2014-12-16
Z-1015-2015	Class II	ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T...	Fresenius Medical Care Renal Therapies Group, LLC	KDI	2014-12-16
Z-1005-2015	Class II	Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2014-12-16
Z-1062-2015	Class II	CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and...	Datascope Corp.	DSP	2014-12-16
Z-2042-2018	Class II	nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by...	NordicNeuroLab AS	LLZ	2014-12-15
Z-1043-2015	Class II	Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for...	Howmedica Osteonics Corp	MEH	2014-12-15
Z-1026-2015	Class II	Beckman Coulter, Lactate Assay, Catalog No. OSR6X93	Siemens Healthcare Diagnostics Inc.	KHP	2014-12-15
Z-1025-2015	Class II	Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16	Siemens Healthcare Diagnostics Inc.	CHH	2014-12-15
Z-1024-2015	Class II	Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98	Siemens Healthcare Diagnostics Inc.	KNK	2014-12-15
Z-1023-2015	Class II	Beckman Coulter, Lipase Assay, Catalog No. OSR6X30	Siemens Healthcare Diagnostics Inc.	CDT	2014-12-15
Z-0994-2015	Class II	Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho...	Siemens Medical Solutions USA, Inc.	KPR	2014-12-15
Z-1021-2015	Class II	2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be...	Synthes GmbH	HXW	2014-12-15
Z-0973-2015	Class II	Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft...	Synthes GmbH	GAD	2014-12-15
Z-1001-2015	Class II	PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1...	Immucor GTI Diagnostics, Inc.	LCO	2014-12-15
Z-1079-2015	Class II	Juno DFR X-ray system	Acteon, Inc.	KXJ	2014-12-14
Z-2773-2015	Class III	Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro...	Horiba Instruments Incorporated	CGX	2014-12-12
Z-1124-2015	Class II	RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is...	Teleflex Medical	BTR	2014-12-12
Z-0965-2015	Class II	MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In...	Biocare Medical LLC	NJT	2014-12-12
Z-2082-2015	Class II	Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot...	Owen Mumford USA, Inc.	FMF	2014-12-11
Z-1052-2015	Class II	Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog...	Zimmer GmbH	OIY	2014-12-11
Z-0964-2015	Class II	MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast...	Mentor	MRD	2014-12-11
Z-0990-2015	Class II	Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist...	Medtec LLC	FMQ	2014-12-11
Z-0989-2015	Class II	Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile...	Medtec LLC	FMQ	2014-12-11
Z-1240-2015	Class II	The I-Cart is used to store, transport, and power video equipment used in medical...	Richard Wolf Medical Instruments Corp.	KMI	2014-12-10
Z-1037-2015	Class II	16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping...	The Anspach Effort, Inc.	HBC	2014-12-10
Z-0966-2015	Class II	GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The...	GE Healthcare	OWB	2014-12-10
Z-1018-2015	Class I	Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015...	Medtronic, Inc.	KRA	2014-12-10
Z-1017-2015	Class I	Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01...	Medtronic, Inc.	KRA	2014-12-10
Z-0649-2016	Class II	iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement...	Siemens Healthcare Diagnostics Inc.	JIL	2014-12-08
Z-1046-2015	Class II	ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures...	Radiometer America, Inc	JJE	2014-12-08
Z-0954-2015	Class II	GE Healthcare, Proteus XR/a with wall stand model number 600-0301.	GE Healthcare	KPR	2014-12-08
Z-1039-2015	Class II	Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path...	Baxter Healthcare Corporation	FKX	2014-12-08
Z-1016-2015	Class II	Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray...	Brainlab, Inc.	JAK	2014-12-08
Z-0979-2015	Class II	Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per...	Philips North America LLC	JAK	2014-12-08
Z-0900-2015	Class II	Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a...	Zimmer GmbH	LOD	2014-12-08
Z-1029-2015	Class II	Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that...	Orthosensor, Inc.	ONN	2014-12-05
Z-0882-2015	Class I	INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432...	Alere San Diego, Inc.	GJS	2014-12-05
Z-0881-2015	Class I	INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio...	Alere San Diego, Inc.	GJS	2014-12-05
Z-0880-2015	Class I	Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071...	Alere San Diego, Inc.	GJS	2014-12-05
Z-0940-2015	Class II	IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System...	Intuitive Surgical, Inc.	NAY	2014-12-05
Z-1036-2015	Class II	G- Series Beds; G29 full length bed rails assembly	Invacare GmbH	FNL	2014-12-05
Z-1455-2015	Class II	DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	2014-12-04