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 759 of 1190

FDA device recalls, page 759 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1197-2013	Class I	Presource PBDS, Knee Arthroscopy, Kit, Circulator	Medtronic, Inc.	OFP	2013-03-26
Z-1196-2013	Class I	Presource PBDS, Major Abdominal, Kit, Circulator	Medtronic, Inc.	OFP	2013-03-26
Z-1195-2013	Class I	Presource PBDS, General Laparoscopy, Kit, Circulator	Medtronic, Inc.	OFP	2013-03-26
Z-1194-2013	Class I	A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp...	Medtronic, Inc.	OFP	2013-03-26
Z-1193-2013	Class I	Presource PBDS, Gyn Laparoscopy Kit, Circulator	Medtronic, Inc.	OFP	2013-03-26
Z-0641-2022	Class III	KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack...	Microbiologics, Inc.	JTR	2013-03-25
Z-1370-2013	Class II	Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per...	Howmedica Osteonics Corp	JWH	2013-03-25
Z-2081-2013	Class III	Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B...	Remel Inc	JTN	2013-03-25
Z-1093-2013	Class III	LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.	Lighthouse for the Blind	LRR	2013-03-22
Z-1092-2013	Class III	LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First...	Lighthouse for the Blind	LRR	2013-03-22
Z-1091-2013	Class III	LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.	Lighthouse for the Blind	LRR	2013-03-22
Z-1090-2013	Class III	LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.	Lighthouse for the Blind	LRR	2013-03-22
Z-1089-2013	Class III	LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.	Lighthouse for the Blind	LRR	2013-03-22
Z-1088-2013	Class III	LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number...	Lighthouse for the Blind	LRR	2013-03-22
Z-1087-2013	Class III	LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305...	Lighthouse for the Blind	LRR	2013-03-22
Z-1086-2013	Class III	LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine...	Lighthouse for the Blind	LRR	2013-03-22
Z-1085-2013	Class II	Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512...	Medtronic, Inc.	OYC	2013-03-22
Z-1176-2013	Class II	ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting...	DePuy Mitek, Inc.	NEW	2013-03-22
Z-1175-2013	Class II	ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles...	DePuy Mitek, Inc.	NEW	2013-03-22
Z-1174-2013	Class II	ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles...	DePuy Mitek, Inc.	NEW	2013-03-22
Z-1173-2013	Class II	ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number...	DePuy Mitek, Inc.	NEW	2013-03-22
Z-1172-2013	Class II	ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in...	DePuy Mitek, Inc.	NEW	2013-03-22
Z-1123-2013	Class II	EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically...	Advanced Sterilization Products	FEB	2013-03-22
Z-1027-2013	Class II	STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization...	Advanced Sterilization Products	MLR	2013-03-22
Z-1026-2013	Class II	STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX...	Advanced Sterilization Products	MLR	2013-03-22
Z-1588-2013	Class II	Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole...	Philips North America LLC	JAK	2013-03-21
Z-1117-2013	Class II	The GemStar Pump is a small and lightweight, single channel infusion device designed for...	Abbott Medical	FRN	2013-03-21
Z-1116-2013	Class II	The GemStar Pump is a small and lightweight, single channel infusion device designed for...	Abbott Medical	FRN	2013-03-21
Z-1167-2013	Class II	AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry...	Siemens Healthcare Diagnostics Inc.	JJE	2013-03-20
Z-1141-2013	Class II	HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02...	Horiba Instruments Incorporated	JGS	2013-03-20
Z-1124-2013	Class II	REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF...	Biomet U.K., Ltd.	NRA	2013-03-20
Z-0422-2015	Class II	GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain...	Abbott Medical	FRN	2013-03-19
Z-0421-2015	Class II	GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain...	Abbott Medical	FRN	2013-03-19
Z-1126-2013	Class II	Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical...	Accuray Incorporated	IYE	2013-03-19
Z-1566-2013	Class II	TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12...	Loma Vista Medical	OZT	2013-03-18
Z-1656-2013	Class II	ARGENT SURGICAL SYSTEMS*BIOPSY Punches* Disposable manual instrument for skin biopsy.	EDM 3, LLC	LRY	2013-03-18
Z-1655-2013	Class II	PSS Select medical products*Biopsy Punches* Disposable manual instrument for skin...	EDM 3, LLC	LRY	2013-03-18
Z-1654-2013	Class II	HealthLink*BIOPSY PUNCHES* Disposable manual instrument for skin biopsy.	EDM 3, LLC	LRY	2013-03-18
Z-1170-2013	Class I	The GemStar Pump is a small and lightweight, single channel infusion device designed for...	Abbott Medical	FRN	2013-03-18
Z-1160-2013	Class I	GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight...	Abbott Medical	FRN	2013-03-18
Z-1159-2013	Class I	GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight...	Abbott Medical	FRN	2013-03-18
Z-1169-2013	Class I	The GemStar Pump is a small and lightweight, single channel infusion device designed for...	Abbott Medical	FRN	2013-03-18
Z-1214-2013	Class II	NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The...	NxStage Medical Inc	KPO	2013-03-18
Z-1369-2013	Class II	Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in...	Shimadzu Medical Systems	IZL	2013-03-18
Z-1055-2013	Class II	Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20...	LeMaitre Vascular Inc.	KFX	2013-03-18
Z-1054-2013	Class II	LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20...	LeMaitre Vascular Inc.	KFX	2013-03-18
Z-1030-2013	Class II	Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for...	Radionics, Inc.	GYC	2013-03-18
Z-1340-2013	Class II	Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers...	Linvatec Corporation	KQM	2013-03-18
Z-1060-2014	Class I	McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a...	Mckesson Technologies, Inc.	BSZ	2013-03-15
Z-1281-2013	Class II	Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work...	Insight Instruments, Inc.	HMX	2013-03-15