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 738 of 1191

FDA device recalls, page 738 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2127-2013	Class I	MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan Synergies...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21
Z-2126-2013	Class I	Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21
Z-2125-2013	Class I	Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21
Z-2124-2013	Class I	Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21
Z-2123-2013	Class I	Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan Synergies plus...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21
Z-2122-2013	Class I	Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan Synergies plus...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21
Z-2121-2013	Class I	Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan Synergies...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21
Z-2120-2013	Class I	Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan Synergies plus...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21
Z-2119-2013	Class I	Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21
Z-0774-2014	Class II	Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a...	Eastman Kodak Company	KPR	2013-08-20
Z-0456-2014	Class II	iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear...	IBA Dosimetry GmbH	IYE	2013-08-20
Z-0032-2014	Class III	FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade...	Bio-Rad Laboratories Inc.	LOM	2013-08-20
Z-2191-2013	Class II	Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for...	Lumenis Ltd	GEX	2013-08-19
Z-2275-2013	Class II	TEGRIS system Four labels of the Tegris System include: Emergency button...	Maquet Cardiovascular Us Sales, LLC	OUG	2013-08-19
Z-2109-2013	Class II	ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood...	Roche Diagnostics GmbH	FMK	2013-08-19
Z-2283-2013	Class II	The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC...	Stryker Medical	FNL	2013-08-19
Z-0062-2017	Class II	Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution...	Siemens Medical Solutions USA, Inc.	KPS	2013-08-16
Z-0061-2017	Class II	Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides...	Siemens Medical Solutions USA, Inc.	KPS	2013-08-16
Z-0021-2014	Class II	GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova...	GE Healthcare	OWB	2013-08-16
Z-2254-2013	Class II	POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to...	Access Scientific, Inc.	DYB	2013-08-16
Z-0067-2014	Class II	Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that...	Philips North America LLC	KPS	2013-08-16
Z-2212-2013	Class II	Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and...	Zeppessis Reprocessing, LLC	JCX	2013-08-16
Z-0173-2014	Class III	ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro...	Siemens Healthcare Diagnostics Inc.	CEW	2013-08-16
Z-2186-2013	Class II	Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID...	Medtronic, Inc.	NGT	2013-08-16
Z-2185-2013	Class II	Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID...	Medtronic, Inc.	NGT	2013-08-16
Z-2184-2013	Class II	Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID...	Medtronic, Inc.	NGT	2013-08-16
Z-2183-2013	Class II	Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID...	Medtronic, Inc.	NGT	2013-08-16
Z-2182-2013	Class II	Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID...	Medtronic, Inc.	NGT	2013-08-16
Z-2181-2013	Class II	Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product...	Medtronic, Inc.	NGT	2013-08-16
Z-2180-2013	Class II	Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID...	Medtronic, Inc.	NGT	2013-08-16
Z-2179-2013	Class II	Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID...	Medtronic, Inc.	NGT	2013-08-16
Z-2178-2013	Class II	Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID...	Medtronic, Inc.	NGT	2013-08-16
Z-0141-2014	Class II	Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor...	STERIS Corporation		2013-08-15
Z-2262-2013	Class II	QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO...	Maquet Cardiovascular Us Sales, LLC	DTZ	2013-08-15
Z-2157-2013	Class II	DMLC IV-ERGO - Beam shaping block for Radiation Therapy.	Elekta Limited	IXI	2013-08-15
Z-1056-2014	Class I	CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-1055-2014	Class I	CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-1054-2014	Class I	STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-1053-2014	Class I	STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-1052-2014	Class I	STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-1051-2014	Class I	CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-1050-2014	Class I	CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-1049-2014	Class I	CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-1048-2014	Class I	HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-1047-2014	Class I	ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-1046-2014	Class I	ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc...	MEDLINE INDUSTRIES, LP - Northfield	LRO	2013-08-14
Z-0008-2014	Class I	Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used...	Draeger, Inc.	BSZ	2013-08-14
Z-2561-2014	Class II	Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799...	Siemens Healthcare Diagnostics Inc.	JQP	2013-08-13
Z-2291-2013	Class II	GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T...	GE Healthcare	LNH	2013-08-13
Z-2300-2013	Class I	MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream...	Cerenovus, Inc.	LKK	2013-08-13