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 664 of 1191

FDA device recalls, page 664 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1097-2015	Class II	AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an...	Teleflex Medical	BTT	2015-01-14
Z-1096-2015	Class II	AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an...	Teleflex Medical	BTT	2015-01-14
Z-1095-2015	Class II	Hudson RCI Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR...	Teleflex Medical	BTT	2015-01-14
Z-1010-2015	Class II	Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic...	Baxter Healthcare Corporation	OCX	2015-01-14
Z-2771-2015	Class II	Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade...	Sony Medical Systems	FWB	2015-01-13
Z-1225-2015	Class II	GE Inspection Technologies x\|argos 160D system. Cabinet x-ray system.	GE Inspection Technologies, LP	RCE	2015-01-13
Z-1211-2015	Class II	GE Inspection Technologies x\|tome\|x L240 an Cabinet X-ray system	GE Inspection Technologies, LP	RCE	2015-01-13
Z-1057-2015	Class II	KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA...	Medtronic Sofamor Danek USA Inc	LYQ	2015-01-13
Z-1320-2015	Class III	cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay	Roche Molecular Systems Inc	OWD	2015-01-13
Z-1268-2015	Class II	ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated...	Med-logics Inc	HNO	2015-01-13
Z-1027-2015	Class II	Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended...	Siemens Medical Solutions USA, Inc.	LLZ	2015-01-13
Z-1053-2015	Class II	SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are...	CareFusion 303, Inc	FPA	2015-01-13
Z-1085-2015	Class II	LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product...	Teleflex Medical	CAE	2015-01-13
Z-1056-2015	Class II	ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000...	Siemens Medical Solutions USA, Inc.	IYN	2015-01-12
Z-1063-2015	Class II	ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected...	Siemens Medical Solutions USA, Inc.	IYO	2015-01-12
Z-1051-2015	Class I	MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8...	Teleflex Medical	BYD	2015-01-12
Z-1058-2015	Class II	Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The...	Medtronic, Inc.	CBK	2015-01-12
Z-1224-2015	Class II	Servo-I ventilator system CO2 analyzer. Part number 65 23 588.	Maquet Cardiovascular Us Sales, LLC	CBN	2015-01-12
Z-1207-2015	Class II	NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211...	Boston Scientific Corporation	OEQ	2015-01-09
Z-1206-2015	Class II	NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1205-2015	Class II	NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1204-2015	Class II	NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1203-2015	Class II	NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1202-2015	Class II	NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1201-2015	Class II	NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1200-2015	Class II	NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185252...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1199-2015	Class II	NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1198-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1197-2015	Class II	NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1196-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 60041632...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1195-2015	Class II	NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1194-2015	Class II	NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No...	Boston Scientific Corporation	OEQ	2015-01-09
Z-1193-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 600207212...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1192-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1191-2015	Class II	NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1190-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1189-2015	Class II	NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1188-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1187-2015	Class II	NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1123-2015	Class II	Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.	Zimmer GmbH	KWA	2015-01-09
Z-1122-2015	Class II	Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component...	Zimmer GmbH	LPH	2015-01-09
Z-1186-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602000571, REF/Catalog No. 60200057...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1185-2015	Class II	NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1184-2015	Class II	NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1183-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 60190043...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1182-2015	Class II	NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1181-2015	Class II	NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1180-2015	Class II	NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1179-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1178-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535...	Boston Scientific Corporation	OEZ	2015-01-09