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 561 of 1191

FDA device recalls, page 561 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0590-2017	Class II	Aptio Automation Modules	Siemens Healthcare Diagnostics Inc.	JJE	2016-09-29
Z-0366-2017	Class II	Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item...	Medtronic, Inc.	LRO	2016-09-29
Z-0365-2017	Class II	Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A...	Medtronic, Inc.	LRO	2016-09-29
Z-1146-2017	Class II	Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm...	Thayer Medical Corportation	CAF	2016-09-29
Z-0076-2017	Class II	Monaco RTP System The Monaco system is used to make treatment plans for patients with...	Elekta Limited	MUJ	2016-09-29
Z-0364-2017	Class II	Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product...	Medtronic, Inc.	LRO	2016-09-29
Z-0778-2017	Class II	ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF...	Boston Scientific Corporation	DYB	2016-09-28
Z-0777-2017	Class II	ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened...	Boston Scientific Corporation	DYB	2016-09-28
Z-0776-2017	Class II	ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened...	Boston Scientific Corporation	DYB	2016-09-28
Z-0775-2017	Class II	ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened...	Boston Scientific Corporation	DYB	2016-09-28
Z-0774-2017	Class II	ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened...	Boston Scientific Corporation	DYB	2016-09-28
Z-0773-2017	Class II	ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened...	Boston Scientific Corporation	DYB	2016-09-28
Z-0772-2017	Class II	ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened...	Boston Scientific Corporation	DYB	2016-09-28
Z-0317-2017	Class II	Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece	Zimmer GmbH	HAB	2016-09-28
Z-0672-2017	Class II	V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum...	Baxter Healthcare Corporation	FRN	2016-09-28
Z-0671-2017	Class II	Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump...	Baxter Healthcare Corporation	FRN	2016-09-28
Z-0670-2017	Class II	sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion...	Baxter Healthcare Corporation	FRN	2016-09-28
Z-0575-2017	Class II	LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer...	Abbott Medical	DRS	2016-09-27
Z-0574-2017	Class II	CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The...	Abbott Medical	DRS	2016-09-27
Z-0573-2017	Class II	Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac Disposable...	Abbott Medical	DRS	2016-09-27
Z-0572-2017	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-0571-2017	Class II	Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac IV, Waste Bag System...	Abbott Medical	DRS	2016-09-27
Z-0570-2017	Class II	Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac IV, 2 Admin Sets and 8 cc Control...	Abbott Medical	DRS	2016-09-27
Z-0569-2017	Class II	Transpac IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way...	Abbott Medical	DRS	2016-09-27
Z-0568-2017	Class II	Transpac IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze...	Abbott Medical	DRS	2016-09-27
Z-0567-2017	Class II	Transpac IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No...	Abbott Medical	DRS	2016-09-27
Z-0566-2017	Class II	Transpac IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and...	Abbott Medical	DRS	2016-09-27
Z-0565-2017	Class II	Transpac IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush...	Abbott Medical	DRS	2016-09-27
Z-0564-2017	Class II	Transpac IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The Transpac...	Abbott Medical	DRS	2016-09-27
Z-0563-2017	Class II	Transpac IV Disposable Transducer w/Stopcocks w/o Cap and Covers, Item No. 46112-30NS The...	Abbott Medical	DRS	2016-09-27
Z-0562-2017	Class II	Transpac IV Monitoring Kit w/Arterial 84" Safeset" Reservoir, 03 ml Squeeze Flush Device...	Abbott Medical	DRS	2016-09-27
Z-0561-2017	Class II	Transpac IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and...	Abbott Medical	DRS	2016-09-27
Z-0560-2017	Class II	Transpac IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset"...	Abbott Medical	DRS	2016-09-27
Z-0559-2017	Class II	Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and...	Abbott Medical	DRS	2016-09-27
Z-0558-2017	Class II	Transpac IV Monitoring Kit w/Safeset" Blood Sampling Port and 03 ml Squeeze Flush Device...	Abbott Medical	DRS	2016-09-27
Z-0557-2017	Class II	Trifurcated Transpac IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir and...	Abbott Medical	DRS	2016-09-27
Z-0556-2017	Class II	Bifurcated Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe...	Abbott Medical	DRS	2016-09-27
Z-0555-2017	Class II	Transpac IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip, Item No. 46106-91 The...	Abbott Medical	DRS	2016-09-27
Z-0554-2017	Class II	Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks...	Abbott Medical	DRS	2016-09-27
Z-0553-2017	Class II	Transpac IV Monitoring Kit w/Safeset 84" Arterial Pressure Tubing, Reservoir, Squeeze...	Abbott Medical	DRS	2016-09-27
Z-0552-2017	Class II	Transpac IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo Flush, Pall Air...	Abbott Medical	DRS	2016-09-27
Z-0551-2017	Class II	TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK...	Abbott Medical	DRS	2016-09-27
Z-0550-2017	Class II	Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip...	Abbott Medical	DRS	2016-09-27
Z-0549-2017	Class II	TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP...	Abbott Medical	DRS	2016-09-27
Z-0548-2017	Class II	Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The...	Abbott Medical	DRS	2016-09-27
Z-0547-2017	Class II	Transpac IV Monitoring Kit w/Safeset 72" Pressure Tubing, Reservoir, 03 ml Squeeze Flush...	Abbott Medical	DRS	2016-09-27
Z-0546-2017	Class II	Transpac IV Monitoring Kit w/ Safeset Reservoir, 24" Tubing,03 ml Intraflo Flush and...	Abbott Medical	DRS	2016-09-27
Z-0545-2017	Class II	TRANSPAC IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO...	Abbott Medical	DRS	2016-09-27
Z-0544-2017	Class II	Transpac w/Safeset Reservoir, Squeeze 03 ml Flush and Needleless Valve, Item No...	Abbott Medical	DRS	2016-09-27
Z-0543-2017	Class II	Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush and...	Abbott Medical	DRS	2016-09-27