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 564 of 1191

FDA device recalls, page 564 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0442-2017	Class II	TRANSPAC IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE...	Abbott Medical	DRS	2016-09-27
Z-0441-2017	Class II	TRANSPAC IV MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MICRODRIP...	Abbott Medical	DRS	2016-09-27
Z-0440-2017	Class II	TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP...	Abbott Medical	DRS	2016-09-27
Z-0439-2017	Class II	TRANSPAC IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH AND MACRODRIP...	Abbott Medical	DRS	2016-09-27
Z-0438-2017	Class II	Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 42598-01 The...	Abbott Medical	DRS	2016-09-27
Z-0437-2017	Class II	Transpac IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure...	Abbott Medical	DRS	2016-09-27
Z-0436-2017	Class II	Transpac IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure...	Abbott Medical	DRS	2016-09-27
Z-0435-2017	Class II	TRANSPAC IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3...	Abbott Medical	DRS	2016-09-27
Z-0434-2017	Class II	TRANSPAC IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE...	Abbott Medical	DRS	2016-09-27
Z-0433-2017	Class II	TRANSPAC IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP...	Abbott Medical	DRS	2016-09-27
Z-0432-2017	Class II	TRANSPAC IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO...	Abbott Medical	DRS	2016-09-27
Z-0431-2017	Class II	TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH, MACRODRIP...	Abbott Medical	DRS	2016-09-27
Z-0430-2017	Class II	TRANSPAC IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH...	Abbott Medical	DRS	2016-09-27
Z-0429-2017	Class II	Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip...	Abbott Medical	DRS	2016-09-27
Z-0428-2017	Class II	TRANSPAC IV MONITORING KIT DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE...	Abbott Medical	DRS	2016-09-27
Z-0427-2017	Class II	Transpac IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device...	Abbott Medical	DRS	2016-09-27
Z-0426-2017	Class II	TRANSPAC IV MONITORING KIT DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (INTENDED...	Abbott Medical	DRS	2016-09-27
Z-0425-2017	Class II	TRANSPAC IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE...	Abbott Medical	DRS	2016-09-27
Z-0424-2017	Class II	TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item No...	Abbott Medical	DRS	2016-09-27
Z-0423-2017	Class II	TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0422-2017	Class II	TRANSPAC IV DISPOSABLE TRANSDUCER, Item No. 42582-05 The Transpac Disposable Straight...	Abbott Medical	DRS	2016-09-27
Z-0421-2017	Class II	TRANSPAC IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2...	Abbott Medical	DRS	2016-09-27
Z-0420-2017	Class II	TRANSPAC IV BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS, 84" TUBING...	Abbott Medical	DRS	2016-09-27
Z-0419-2017	Class II	TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0418-2017	Class II	TRANSPAC IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER WITH 2...	Abbott Medical	DRS	2016-09-27
Z-0417-2017	Class II	TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item...	Abbott Medical	DRS	2016-09-27
Z-0416-2017	Class II	Transpac IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo...	Abbott Medical	DRS	2016-09-27
Z-0415-2017	Class II	TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item...	Abbott Medical	DRS	2016-09-27
Z-0414-2017	Class II	4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0387-2017	Class II	Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical...	Roche Diagnostics GmbH	JJE	2016-09-27
Z-0965-2017	Class II	EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH...	Advanced Sterilization Products	FEB	2016-09-27
Z-0372-2017	Class II	Replacement floor locking cylinders for the Schaerer model 7300 surgical tables...	Ohio Medical Instrument Co., Inc.	JEB	2016-09-27
Z-0371-2017	Class II	The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached...	Ohio Medical Instrument Co., Inc.	JEB	2016-09-27
Z-0348-2017	Class II	Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies...	Maquet Cardiovascular Us Sales, LLC	DWC	2016-09-27
Z-0666-2017	Class II	Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to...	Hamilton Medical AG	CBK	2016-09-26
Z-2221-2017	Class III	Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation...	Neogen Culture Media	JSI	2016-09-25
Z-0301-2017	Class II	FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip...	Lumenis Ltd	GEX	2016-09-25
Z-0068-2017	Class II	BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy...	Surgical Specialties Mexico S de RL de CV	OMT	2016-09-24
Z-0635-2017	Class II	Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A	Merit Medical Systems, Inc.	OJV	2016-09-23
Z-0634-2017	Class II	Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G	Merit Medical Systems, Inc.	OJV	2016-09-23
Z-0633-2017	Class II	Waste Management Kit. Catalog Number K10-04381AP	Merit Medical Systems, Inc.	OJV	2016-09-23
Z-0632-2017	Class II	Manifold Kit. Catalog Number K09-11867AP	Merit Medical Systems, Inc.	OJV	2016-09-23
Z-0631-2017	Class II	Fluid Management Set. Catalog Number K08-MP5159A	Merit Medical Systems, Inc.	OJV	2016-09-23
Z-0071-2017	Class II	OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The...	GE Healthcare	OXO	2016-09-23
Z-0069-2017	Class II	V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes...	Medtronic, Inc.	LXH	2016-09-23
Z-0114-2017	Class II	VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is...	Sequent Medical, Inc.	KRA	2016-09-23
Z-0653-2017	Class II	COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion...	AtriCure, Inc.	OCL	2016-09-22
Z-0377-2017	Class II	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for...	AtriCure, Inc.	FZP	2016-09-22
Z-0070-2017	Class II	Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number...	Medtronic Navigation, Inc	OWB	2016-09-22
Z-0128-2017	Class II	CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an...	Becton, Dickinson and Company, BD Biosciences	MVU	2016-09-21