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 563 of 1191

FDA device recalls, page 563 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0492-2017	Class II	MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No...	Abbott Medical	DRS	2016-09-27
Z-0491-2017	Class II	Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure...	Abbott Medical	DRS	2016-09-27
Z-0490-2017	Class II	MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA, Item No. 46080-51 The...	Abbott Medical	DRS	2016-09-27
Z-0489-2017	Class II	TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0488-2017	Class II	CATH LAB KIT FOR BAPTIST M. C., Item No. 46078-52 The Transpac Disposable Straight...	Abbott Medical	DRS	2016-09-27
Z-0487-2017	Class II	Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 The Transpac Disposable Straight...	Abbott Medical	DRS	2016-09-27
Z-0486-2017	Class II	HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0485-2017	Class II	Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-26 The...	Abbott Medical	DRS	2016-09-27
Z-0484-2017	Class II	SINGLE LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-25 The...	Abbott Medical	DRS	2016-09-27
Z-0483-2017	Class II	TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21 The...	Abbott Medical	DRS	2016-09-27
Z-0482-2017	Class II	MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 The...	Abbott Medical	DRS	2016-09-27
Z-0481-2017	Class II	CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 The...	Abbott Medical	DRS	2016-09-27
Z-0480-2017	Class II	TRIPLE PRESSURE KIT WITH 03ML FLUSH DEVICE FOR METHODIST M.C. OF ILLINOIS, Item No...	Abbott Medical	DRS	2016-09-27
Z-0479-2017	Class II	RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0478-2017	Class II	PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 The Transpac Disposable Straight...	Abbott Medical	DRS	2016-09-27
Z-0477-2017	Class II	KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0476-2017	Class II	NEONATAL KIT WITH 30ML FLUSH DEVICE FOR YALE-NEW HAVEN HOSP., Item No. 46068-65 The...	Abbott Medical	DRS	2016-09-27
Z-0475-2017	Class II	ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49 The...	Abbott Medical	DRS	2016-09-27
Z-0474-2017	Class II	OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No...	Abbott Medical	DRS	2016-09-27
Z-0473-2017	Class II	M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No...	Abbott Medical	DRS	2016-09-27
Z-0472-2017	Class II	RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable...	Abbott Medical	DRS	2016-09-27
Z-0471-2017	Class II	LEFT HEART KIT FOR PORTLAND ADVENTIST HOSP., Item No. 46066-13 The Transpac Disposable...	Abbott Medical	DRS	2016-09-27
Z-0470-2017	Class II	PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No...	Abbott Medical	DRS	2016-09-27
Z-0469-2017	Class II	ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-64 The...	Abbott Medical	DRS	2016-09-27
Z-0468-2017	Class II	TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The...	Abbott Medical	DRS	2016-09-27
Z-0467-2017	Class II	OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No...	Abbott Medical	DRS	2016-09-27
Z-0466-2017	Class II	CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Disposable...	Abbott Medical	DRS	2016-09-27
Z-0465-2017	Class II	BIFURCATED TRANSPAC 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL HOSP., Item No...	Abbott Medical	DRS	2016-09-27
Z-0464-2017	Class II	TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 46063-11 The...	Abbott Medical	DRS	2016-09-27
Z-0463-2017	Class II	DOUBLE LINE KIT WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN HOSP., Item No...	Abbott Medical	DRS	2016-09-27
Z-0462-2017	Class II	KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Disposable...	Abbott Medical	DRS	2016-09-27
Z-0461-2017	Class II	ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059-28 The...	Abbott Medical	DRS	2016-09-27
Z-0460-2017	Class II	CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpac Disposable...	Abbott Medical	DRS	2016-09-27
Z-0459-2017	Class II	MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0458-2017	Class II	ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0457-2017	Class II	CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposable Straight...	Abbott Medical	DRS	2016-09-27
Z-0456-2017	Class II	SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 46047-17 The...	Abbott Medical	DRS	2016-09-27
Z-0455-2017	Class II	Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0454-2017	Class II	TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No...	Abbott Medical	DRS	2016-09-27
Z-0453-2017	Class II	TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS...	Abbott Medical	DRS	2016-09-27
Z-0452-2017	Class II	TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML SQUEEZE...	Abbott Medical	DRS	2016-09-27
Z-0451-2017	Class II	TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60"...	Abbott Medical	DRS	2016-09-27
Z-0450-2017	Class II	TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO...	Abbott Medical	DRS	2016-09-27
Z-0449-2017	Class II	TRANSPAC IV MONITORING KIT SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING...	Abbott Medical	DRS	2016-09-27
Z-0448-2017	Class II	TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING...	Abbott Medical	DRS	2016-09-27
Z-0447-2017	Class II	TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING...	Abbott Medical	DRS	2016-09-27
Z-0446-2017	Class II	TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING...	Abbott Medical	DRS	2016-09-27
Z-0445-2017	Class II	TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING...	Abbott Medical	DRS	2016-09-27
Z-0444-2017	Class II	TRANSPAC IV MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 30 ML...	Abbott Medical	DRS	2016-09-27
Z-0443-2017	Class II	TRANSPAC IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP...	Abbott Medical	DRS	2016-09-27