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 611 of 1191

FDA device recalls, page 611 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1080-2016	Class II	Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001...	Value Plastics, Inc.	FMG	2015-12-18
Z-1359-2016	Class II	BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended...	C.R. Bard Inc	MJC	2015-12-18
Z-1358-2016	Class II	BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder...	C.R. Bard Inc	MJC	2015-12-18
Z-1357-2016	Class II	BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary...	C.R. Bard Inc	MJC	2015-12-18
Z-0659-2016	Class II	VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in...	LivaNova USA, Inc.	LYJ	2015-12-18
Z-0604-2016	Class II	Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The...	Elekta Limited	MUJ	2015-12-18
Z-0631-2016	Class I	arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX...	Arkray Factory USA, Inc.	CGA	2015-12-18
Z-0630-2016	Class I	arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog #...	Arkray Factory USA, Inc.	CGA	2015-12-18
Z-1195-2016	Class II	Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog #...	Arthrex GmbH	JWH	2015-12-17
Z-1022-2016	Class II	BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission...	Philips North America LLC	KPS	2015-12-17
Z-1021-2016	Class II	BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.	Philips North America LLC	KPS	2015-12-17
Z-1020-2016	Class II	BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.	Philips North America LLC	KPS	2015-12-17
Z-0794-2016	Class II	RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0...	Merge Healthcare Incorporated	LLZ	2015-12-17
Z-0629-2016	Class II	Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers...	Stryker Sustainability Solutions	KCY	2015-12-17
Z-1231-2016	Class II	GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.	GE Inspection Technologies, LP	RCE	2015-12-16
Z-0852-2016	Class II	AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system...	Howmedica Osteonics Corp	MAX	2015-12-16
Z-1248-2016	Class II	Cardiosave Hybrid and rescue IABP	Datascope Corp.	DSP	2015-12-16
Z-1244-2016	Class II	MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for...	Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work	IYE	2015-12-15
Z-0682-2016	Class II	Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN...	GE Healthcare	BSZ	2015-12-15
Z-0681-2016	Class II	GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2...	GE Healthcare	BSZ	2015-12-15
Z-0680-2016	Class II	GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is...	GE Healthcare	BSZ	2015-12-15
Z-0679-2016	Class II	GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900...	GE Healthcare	BSZ	2015-12-15
Z-0678-2016	Class II	GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900...	GE Healthcare	CBK	2015-12-15
Z-0677-2016	Class II	GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of...	GE Healthcare	BSZ	2015-12-15
Z-0695-2016	Class II	D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated...	Bio-Rad Laboratories Inc.	LCP	2015-12-15
Z-0693-2016	Class II	Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111	Fresenius Medical Care Renal Therapies Group, LLC	FKX	2015-12-15
Z-0690-2016	Class II	Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G...	Globalmed Logistix LLC	MUU	2015-12-15
Z-0701-2016	Class II	Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station...	Datascope Corp.	MHX	2015-12-15
Z-1866-2017	Class II	BD Viper LT software, version 3.00H	Becton Dickinson & Co	OOI	2015-12-14
Z-0792-2016	Class II	Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and...	Mizuho Orthopedic Systems Inc	GDC	2015-12-14
Z-0628-2016	Class III	FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.	Becton, Dickinson and Company, BD Biosciences	MVU	2015-12-14
Z-0001-2017	Class III	CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S...	Terumo Cardiovascular Systems Corporation	DRY	2015-12-11
Z-0595-2016	Class II	MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For...	Canadian Hospital Specialties Ltd.	FPD	2015-12-11
Z-1638-2016	Class II	Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for...	Ascom (US) Inc.	MSX	2015-12-10
Z-0804-2016	Class I	Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System...	Maquet Cardiovascular Us Sales, LLC	BSZ	2015-12-10
Z-0683-2016	Class II	IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2	IBA Dosimetry GmbH	IYE	2015-12-10
Z-0621-2016	Class II	Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat...	Boston Scientific Corporation	LWP	2015-12-10
Z-0620-2016	Class II	Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat...	Boston Scientific Corporation	LWP	2015-12-10
Z-1076-2016	Class II	BD Intelliport Medication Management System Sensor The system is indicated for use by...	Becton Dickinson & Co	PHC	2015-12-09
Z-0654-2016	Class II	Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes...	Zimmer GmbH	HRS	2015-12-09
Z-0646-2016	Class II	Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer...	Zimmer GmbH	HWC	2015-12-09
Z-0596-2016	Class II	Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841...	Philips North America LLC	IYN	2015-12-09
Z-0557-2016	Class II	MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to...	Elekta Limited	IYE	2015-12-09
Z-1387-2016	Class II	SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura...	Synthes (USA) Products LLC	GXQ	2015-12-08
Z-1386-2016	Class II	SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura...	Synthes (USA) Products LLC	GXQ	2015-12-08
Z-1385-2016	Class II	SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura...	Synthes (USA) Products LLC	GXQ	2015-12-08
Z-1384-2016	Class II	SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura...	Synthes (USA) Products LLC	GXQ	2015-12-08
Z-1383-2016	Class II	SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura...	Synthes (USA) Products LLC	GXQ	2015-12-08
Z-0466-2016	Class II	Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No...	Synvasive Technology, Inc.	GFA	2015-12-08
Z-0626-2016	Class II	AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog...	Encore Medical, LP	PHX	2015-12-08