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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 769 of 1190

FDA device recalls, page 769 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0978-2013	Class II	Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered...	Medtronic, Inc.	FSM	2012-12-18
Z-0987-2013	Class II	ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative...	Abbott Medical	LOM	2012-12-18
Z-0629-2013	Class II	Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model...	Stryker Medical	FNL	2012-12-18
Z-0628-2013	Class II	Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is...	Stryker Medical	FNL	2012-12-18
Z-0937-2013	Class II	Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple...	Vygon U.S.A.	LJS	2012-12-17
Z-0836-2013	Class III	Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion...	Animas Corp.	LZG	2012-12-17
Z-0791-2013	Class II	Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total...	Medacta USA, Inc.	MEH	2012-12-17
Z-0810-2013	Class II	Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.	Mizuho Orthopedic Systems Inc	JEA	2012-12-17
Z-0877-2013	Class II	QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is...	Intel-Ge Care Innovations, LLC	KMI	2012-12-16
Z-2687-2016	Class II	Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume...	Baxter Healthcare Corporation	FPA	2012-12-14
Z-0347-2014	Class II	Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET...	Riverpoint Medical, LLC	NEW	2012-12-13
Z-1128-2013	Class II	SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters...	Sr Instruments Inc	FRW	2012-12-13
Z-0898-2013	Class II	REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power...	Medical Components, Inc.	LJS	2012-12-13
Z-0939-2013	Class II	Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783...	Draeger, Inc.	MHX	2012-12-13
Z-0699-2013	Class II	Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500...	Becton Dickinson & Co	JSS	2012-12-13
Z-0755-2013	Class II	Ortho Clinical Diagnostics VITROS Chemistry Products Vapor Adsorption Cartridge REF/CAT...	Ortho-Clinical Diagnostics, Inc.	JJE	2012-12-13
Z-0702-2013	Class II	Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product...	Philips North America LLC	RCA	2012-12-13
Z-0765-2013	Class II	Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted...	Ormco/Sybronendo	EKS	2012-12-12
Z-0698-2013	Class II	Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27...	Abbott Medical	MRG	2012-12-12
Z-1104-2013	Class II	Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number...	Canon Medical Systems USA, Inc.	ITX	2012-12-11
Z-0976-2013	Class II	BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR...	Becton Dickinson & Co	NJR	2012-12-11
Z-0700-2013	Class II	GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance...	American Medical Systems Innovation Center - Silicon Valley	GEX	2012-12-11
Z-0739-2013	Class II	BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part...	Becton Dickinson & Co	JSC	2012-12-10
Z-0664-2013	Class II	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay...	Siemens Healthcare Diagnostics Inc.	DLZ	2012-12-10
Z-0615-2013	Class II	Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis...	Arjo, Inc.	JOW	2012-12-10
Z-1103-2013	Class II	Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software...	Integra LifeSciences Corporation	MUJ	2012-12-10
Z-0626-2013	Class II	Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045...	Abbott Medical	FRN	2012-12-07
Z-0625-2013	Class II	Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps...	Abbott Medical	FRN	2012-12-07
Z-0624-2013	Class II	Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps...	Abbott Medical	FRN	2012-12-07
Z-0665-2013	Class III	Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM)...	Siemens Healthcare Diagnostics Inc.	DKB	2012-12-06
Z-0622-2013	Class II	Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can...	Hill-Rom Inc.	FSA	2012-12-06
Z-1404-2013	Class II	Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This...	Canon Inc.	HKO	2012-12-05
Z-2175-2013	Class II	Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used...	B Braun Medical Inc	FRN	2012-12-05
Z-0694-2013	Class II	Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys...	GE Healthcare	DQK	2012-12-05
Z-0620-2013	Class II	Companion External Battery, Part Number: 293001-001 The Companion External Battery is a...	SynCardia Systems LLC	DSZ	2012-12-05
Z-0634-2013	Class II	Abbott m2000sp Instrument; an automated fluid handling system for performing sample...	Abbott Molecular, Inc.	JJH	2012-12-04
Z-0819-2013	Class II	Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.	Ortho-Clinical Diagnostics, Inc.	GNX	2012-12-03
Z-0674-2013	Class II	Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64...	Philips North America LLC	JAK	2012-12-03
Z-0567-2013	Class II	Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx...	Medtronic Neuromodulation	MHY	2012-12-03
Z-0592-2013	Class II	SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03
Z-0591-2013	Class II	SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03
Z-0590-2013	Class II	SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03
Z-0589-2013	Class II	SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03
Z-0588-2013	Class II	SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03
Z-0587-2013	Class II	SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03
Z-0586-2013	Class II	SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03
Z-0585-2013	Class II	SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03
Z-0584-2013	Class II	SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03
Z-0583-2013	Class II	SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03
Z-0582-2013	Class II	SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with...	Depuy Orthopaedics Inc.	LPH	2012-12-03