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 562 of 1191

FDA device recalls, page 562 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0542-2017	Class II	TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve...	Abbott Medical	DRS	2016-09-27
Z-0541-2017	Class II	Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac IV...	Abbott Medical	DRS	2016-09-27
Z-0540-2017	Class II	Cath Lab Kit w/Waste Bag System, 3 Port "OFF" Manifold (600 psi), Transpac IV, 72" Spike...	Abbott Medical	DRS	2016-09-27
Z-0539-2017	Class II	5 Port "OFF" Manifold w/TRANSPAC IV, Item No. 46100-29 The Transpac Disposable Straight...	Abbott Medical	DRS	2016-09-27
Z-0538-2017	Class II	Transpac 4 kit w/72" Macrodrip Admin Set, Item No. 46099-77 The Transpac Disposable...	Abbott Medical	DRS	2016-09-27
Z-0537-2017	Class II	CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposable Straight...	Abbott Medical	DRS	2016-09-27
Z-0536-2017	Class II	Quad Kit W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0535-2017	Class II	DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac Disposable...	Abbott Medical	DRS	2016-09-27
Z-0534-2017	Class II	Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringes and 3 Way...	Abbott Medical	DRS	2016-09-27
Z-0533-2017	Class II	2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK...	Abbott Medical	DRS	2016-09-27
Z-0532-2017	Class II	4 PORT "OFF" MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS, Item No...	Abbott Medical	DRS	2016-09-27
Z-0531-2017	Class II	CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4...	Abbott Medical	DRS	2016-09-27
Z-0530-2017	Class II	CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4...	Abbott Medical	DRS	2016-09-27
Z-0529-2017	Class II	Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No...	Abbott Medical	DRS	2016-09-27
Z-0528-2017	Class II	Cath Lab Kit w/Waste Bag, dyePod, Sosa Spike & Syringe, Item No. 46098-11 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0527-2017	Class II	SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item...	Abbott Medical	DRS	2016-09-27
Z-0526-2017	Class II	TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item...	Abbott Medical	DRS	2016-09-27
Z-0525-2017	Class II	TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0524-2017	Class II	TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The...	Abbott Medical	DRS	2016-09-27
Z-0523-2017	Class II	QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The...	Abbott Medical	DRS	2016-09-27
Z-0522-2017	Class II	PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33 The...	Abbott Medical	DRS	2016-09-27
Z-0521-2017	Class II	SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0520-2017	Class II	CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No...	Abbott Medical	DRS	2016-09-27
Z-0519-2017	Class II	CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Transducer...	Abbott Medical	DRS	2016-09-27
Z-0518-2017	Class II	CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33 The...	Abbott Medical	DRS	2016-09-27
Z-0517-2017	Class II	PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0516-2017	Class II	Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and...	Abbott Medical	DRS	2016-09-27
Z-0515-2017	Class II	Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children, Item No...	Abbott Medical	DRS	2016-09-27
Z-0514-2017	Class II	MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0513-2017	Class II	QUAD KIT WITH THREE TRANSPAC AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No...	Abbott Medical	DRS	2016-09-27
Z-0512-2017	Class II	MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0511-2017	Class II	TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0510-2017	Class II	BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0509-2017	Class II	OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 The...	Abbott Medical	DRS	2016-09-27
Z-0508-2017	Class II	PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No...	Abbott Medical	DRS	2016-09-27
Z-0507-2017	Class II	CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight...	Abbott Medical	DRS	2016-09-27
Z-0506-2017	Class II	TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0505-2017	Class II	PERFUSION KIT FOR UNIV. OF IOWA, Item No. 46091-51 The Transpac Disposable Straight...	Abbott Medical	DRS	2016-09-27
Z-0504-2017	Class II	ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No...	Abbott Medical	DRS	2016-09-27
Z-0503-2017	Class II	MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0502-2017	Class II	CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 The...	Abbott Medical	DRS	2016-09-27
Z-0501-2017	Class II	Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The...	Abbott Medical	DRS	2016-09-27
Z-0500-2017	Class II	CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The...	Abbott Medical	DRS	2016-09-27
Z-0499-2017	Class II	CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable Straight...	Abbott Medical	DRS	2016-09-27
Z-0498-2017	Class II	TRIFURCATED DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS HOPKINS/BAYVIEW, Item...	Abbott Medical	DRS	2016-09-27
Z-0497-2017	Class II	TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 The...	Abbott Medical	DRS	2016-09-27
Z-0496-2017	Class II	CATH LAB KIT WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0495-2017	Class II	ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No...	Abbott Medical	DRS	2016-09-27
Z-0494-2017	Class II	TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No...	Abbott Medical	DRS	2016-09-27
Z-0493-2017	Class II	MONITORING KIT WITH 03ML FLUSH DEVICE FOR UNIV. OF NEW MEXICO, Item No. 46085-50 The...	Abbott Medical	DRS	2016-09-27