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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 473 of 1191

FDA device recalls, page 473 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2813-2018	Class II	10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2812-2018	Class II	10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2811-2018	Class II	61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2810-2018	Class II	38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2809-2018	Class II	PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2808-2018	Class II	40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2807-2018	Class II	191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2806-2018	Class II	Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2805-2018	Class II	PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2804-2018	Class II	28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2803-2018	Class II	18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2802-2018	Class II	43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2801-2018	Class II	216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2800-2018	Class II	DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2799-2018	Class II	30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2798-2018	Class II	165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2797-2018	Class II	20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave...	ICU MEDICAL de MEXICO, S. de R.L. de C.V.	FMG	2018-03-01
Z-2588-2018	Class II	VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated...	bioMerieux, Inc.	JJE	2018-03-01
Z-1484-2018	Class I	Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are...	Draeger, Inc.	BSZ	2018-03-01
Z-1483-2018	Class I	Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are...	Draeger, Inc.	BSZ	2018-03-01
Z-1482-2018	Class I	Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products...	Draeger, Inc.	BSZ	2018-03-01
Z-1481-2018	Class I	Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are...	Draeger, Inc.	BSZ	2018-03-01
Z-1192-2018	Class II	Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma...	Zimmer GmbH	LPH	2018-03-01
Z-1191-2018	Class II	Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma...	Zimmer GmbH	LPH	2018-03-01
Z-1640-2018	Class II	PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of...	Vygon U.S.A.	OWL	2018-02-28
Z-1639-2018	Class II	PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of...	Vygon U.S.A.	OWL	2018-02-28
Z-1638-2018	Class II	Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs...	Vygon U.S.A.	OWL	2018-02-28
Z-1637-2018	Class II	PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the...	Vygon U.S.A.	OWL	2018-02-28
Z-1636-2018	Class II	Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the...	Vygon U.S.A.	OWL	2018-02-28
Z-1635-2018	Class II	Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of...	Vygon U.S.A.	OWL	2018-02-28
Z-1634-2018	Class II	Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of...	Vygon U.S.A.	OWL	2018-02-28
Z-1633-2018	Class II	PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the...	Vygon U.S.A.	OWL	2018-02-28
Z-1525-2018	Class II	Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI...	Zimmer GmbH	LZO	2018-02-28
Z-1524-2018	Class II	Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01)...	Zimmer GmbH	LZO	2018-02-28
Z-1173-2018	Class II	Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for...	Zimmer GmbH	KWT	2018-02-28
Z-0297-2020	Class III	SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and...	Helena Laboratories, Corp.	JBD	2018-02-27
Z-0405-2019	Class II	FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions...	Integrity Implants, Inc.	MAX	2018-02-27
Z-1357-2018	Class II	Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R)...	C.R. Bard Inc	FPD	2018-02-27
Z-1356-2018	Class II	Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R)...	C.R. Bard Inc	FPD	2018-02-27
Z-1355-2018	Class II	Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R)...	C.R. Bard Inc	FPD	2018-02-27
Z-1354-2018	Class II	Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R)...	C.R. Bard Inc	FPD	2018-02-27
Z-1582-2018	Class II	AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to...	Radiometer Medical ApS	CHL	2018-02-27
Z-1075-2018	Class II	Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a...	Iridex Corporation	GEX	2018-02-27
Z-1953-2018	Class II	Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1...	Genesee BioMedical, Inc.	DWS	2018-02-26
Z-1801-2018	Class II	Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267...	Becton Dickinson & Co	GEI	2018-02-26
Z-1539-2018	Class II	WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to...	Becton Dickinson & Co	GEI	2018-02-26
Z-1588-2018	Class II	Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical...	Siemens Healthcare Diagnostics Inc.	JJE	2018-02-26
Z-1587-2018	Class II	Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of...	Siemens Healthcare Diagnostics Inc.	JGS	2018-02-26
Z-1586-2018	Class II	Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.	Siemens Healthcare Diagnostics Inc.	JJE	2018-02-26
Z-1701-2018	Class I	MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF...	Medtronic, Inc.	NRY	2018-02-26