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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 513 of 1191

FDA device recalls, page 513 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-3101-2017	Class II	UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version...	Siemens Healthcare Diagnostics Inc.	GKZ	2017-06-20
Z-0335-2018	Class II	Intellicuff Standalone (PN 951001) Used to continuously measure and automatically...	Hamilton Medical AG	BSK	2017-06-20
Z-0805-2018	Class II	STAT 2 I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension...	ConMed Corporation	FPA	2017-06-19
Z-0804-2018	Class II	STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration Sets and...	ConMed Corporation	LDR	2017-06-19
Z-2660-2017	Class II	Nussloch GmbH ASP6025 Tissue Processor	Leica Microsystems, Inc.	IEO	2017-06-19
Z-3017-2017	Class II	iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with...	Elekta Limited	IYE	2017-06-19
Z-2732-2017	Class II	Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG...	Nova Biomedical Corporation	CHL	2017-06-19
Z-0718-2018	Class II	Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number...	Keystone Dental Inc.	DZE	2017-06-16
Z-0269-2018	Class II	ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed...	Zimmer GmbH	KWI	2017-06-16
Z-2738-2017	Class I	CS 300 Intra-Aortic Balloon Pump	Datascope Corp.	DSP	2017-06-16
Z-2737-2017	Class I	CS 100 Intra-Aortic Balloon Pump	Datascope Corp.	DSP	2017-06-16
Z-2736-2017	Class I	CS 100i Intra-Aortic Balloon Pump	Datascope Corp.	DSP	2017-06-16
Z-0771-2018	Class II	Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Product...	STERIS Corporation	FRG	2017-06-15
Z-0770-2018	Class II	Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0769-2018	Class II	Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product...	STERIS Corporation	FRG	2017-06-15
Z-0768-2018	Class II	Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0767-2018	Class II	Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product...	STERIS Corporation	FRG	2017-06-15
Z-0766-2018	Class II	Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0765-2018	Class II	Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0764-2018	Class II	Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0763-2018	Class II	Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0762-2018	Class II	Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0761-2018	Class II	Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0760-2018	Class II	Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product...	STERIS Corporation	FRG	2017-06-15
Z-0759-2018	Class II	Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product...	STERIS Corporation	FRG	2017-06-15
Z-0758-2018	Class II	Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0757-2018	Class II	Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product...	STERIS Corporation	FRG	2017-06-15
Z-0756-2018	Class II	Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case Product...	STERIS Corporation	FRG	2017-06-15
Z-0755-2018	Class II	Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0754-2018	Class II	Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0753-2018	Class II	Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0752-2018	Class II	Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0751-2018	Class II	Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0750-2018	Class II	Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0749-2018	Class II	Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product...	STERIS Corporation	FRG	2017-06-15
Z-0748-2018	Class II	Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product...	STERIS Corporation	FRG	2017-06-15
Z-0747-2018	Class II	Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per case 6...	STERIS Corporation	FRG	2017-06-15
Z-0746-2018	Class II	Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6...	STERIS Corporation	FRG	2017-06-15
Z-0745-2018	Class II	Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10...	STERIS Corporation	FRG	2017-06-15
Z-0744-2018	Class II	Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10...	STERIS Corporation	FRG	2017-06-15
Z-0743-2018	Class II	Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2017-06-15
Z-0383-2018	Class II	PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The...	Integra LifeSciences Braintree Inc.	KGN	2017-06-15
Z-0232-2018	Class II	FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU...	FUJIFILM Healthcare Americas Corporation	KPR	2017-06-15
Z-3059-2017	Class II	Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a)...	Custom Assemblies Inc	LRO	2017-06-15
Z-3043-2017	Class II	Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c)...	Boston Scientific Corporation	MAV	2017-06-15
Z-3031-2017	Class II	Plum 360 Infusion System	Abbott Medical	FRN	2017-06-15
Z-3072-2017	Class II	mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System...	Medspira, LLC	GBT	2017-06-14
Z-0210-2018	Class II	SMARTABLATE RF System Generator	Biosense Webster Inc	LPB	2017-06-14
Z-2714-2017	Class II	ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent...	Arjo, Inc.	JOW	2017-06-14
Z-3020-2017	Class II	VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 106. Product...	LivaNova USA, Inc.	LYJ	2017-06-13