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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 809 of 1190

FDA device recalls, page 809 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1397-2012		Sterile surgical kits containing the Umbilicup device: DeRoyal (R) VAGINAL DELIVERY PACK...	DeRoyal Industries, Inc.	LRP	2012-01-20
Z-1396-2012		DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell...	DeRoyal Industries, Inc.	KSR	2012-01-20
Z-1127-2012		Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image...	Siemens Medical Solutions USA, Inc.	LLZ	2012-01-20
Z-0918-2012		NanoKnife Irreversible Electroporation System. System consists of multiple components...	Angiodynamics Worldwide Headquarters	OAB	2012-01-20
Z-0817-2016	Class II	MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK...	Nihon Kohden America Inc	GWF	2012-01-19
Z-1400-2012		TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare...	Scottcare Corporation	DSI	2012-01-19
Z-1135-2012		Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476. The...	Boston Scientific Corporation	LWS	2012-01-19
Z-1655-2012		Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F...	Vascular Solutions LLC	DQY	2012-01-17
Z-1520-2012		Product is labeled in part: "*is immunosimplicityHSV 1&2 IgM**Enzyme Immunoassay...	Diamedix Corp.	LGC	2012-01-16
Z-1454-2012		Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension...	Siemens Healthcare Diagnostics Inc.	JJE	2012-01-16
Z-1091-2012		Varian brand 52-leaf Millennium MLC multileaf collimator; Reference/FSCA Identifier...	Varian Medical Systems, Inc.	IYE	2012-01-16
Z-1090-2012		Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA...	Varian Medical Systems, Inc.	IYE	2012-01-16
Z-1062-2012		Agfa DX-D Imaging Package - (The detector power cables described in the Report of...	AGFA Healthcare Corp.	MQB	2012-01-16
Z-1098-2012		CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan...	Accuray Incorporated	IYE	2012-01-16
Z-0927-2012		AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic...	Siemens Medical Solutions USA, Inc.	JAA	2012-01-16
Z-2033-2012	Class II	Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1...	Howmedica Osteonics Corp	LXH	2012-01-13
Z-1103-2012		Sunrise Medical Zippie TS wheelchair To empower physically challenged person by...	Sunrise Medical, Inc.	IOR	2012-01-13
Z-1057-2012		Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following...	ZOLL Medical Corporation	MKJ	2012-01-13
Z-1198-2012		Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the...	Stryker Corp.	KIH	2012-01-13
Z-0840-2012		Roller Pump, 6 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use...	Terumo Cardiovascular Systems Corporation	DTQ	2012-01-13
Z-0839-2012		Roller Pump, 4 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use...	Terumo Cardiovascular Systems Corporation	DTQ	2012-01-13
Z-1706-2012		Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026...	Howmedica Osteonics Corp	NKB	2012-01-12
Z-0998-2012		DUET TRS 60 4.8MM ARTICULATING SULU Product Code: DUET6048A Product Usage: The ENDO...	Medtronic, Inc.	GDW	2012-01-12
Z-0997-2012		DUET TRS 60 4.8MM STRAIGHT SULU Product Code: DUET6048 Product Usage: The ENDO GIA...	Medtronic, Inc.	GDW	2012-01-12
Z-0996-2012		DUET TRS 60 3.5MM ARTICULATING SULU Product Code: DUET6035A Product Usage: The ENDO GIA...	Medtronic, Inc.	GDW	2012-01-12
Z-0995-2012		DUET TRS 60 3.5MM STRAIGHT SULU Product Code: DUET6035 Product Usage: The ENDO GIA...	Medtronic, Inc.	GDW	2012-01-12
Z-0994-2012		DUET TRS 45 4.8MM ARTICULATING SULU Product Code: DUET4548A Product Usage: The ENDO...	Medtronic, Inc.	GDW	2012-01-12
Z-0993-2012		DUET TRS 45 4.8MM STRAIGHT SULU Product Code: DUET4548 Product Usage: The ENDO GIA...	Medtronic, Inc.	GDW	2012-01-12
Z-0992-2012		DUET TRS 45 3.5MM ARTICULATING SULU Product Code: DUET4535A Product Usage: The ENDO GIA...	Medtronic, Inc.	GDW	2012-01-12
Z-0991-2012		DUET TRS 45 3.5MM STRAIGHT SULU Product Code: DUET4535 Product Usage: The ENDO GIA...	Medtronic, Inc.	GDW	2012-01-12
Z-0817-2012		Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical...	Abbott Medical	FPA	2012-01-12
Z-1109-2012		BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was...	Becton Dickinson & Co	LKA	2012-01-11
Z-1108-2012		BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was...	Becton Dickinson & Co	LKA	2012-01-11
Z-1012-2012		Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0...	Cytophil, Inc	LYC	2012-01-11
Z-1191-2012		Microsoft Amalga UIS 2009 is Microsoft Amalga Unified Intelligence System (UIS)...	Microsoft Corporation Health Solutions Group	JQP	2012-01-11
Z-0966-2012		Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS#...	Given Imaging Ltd.	LLT	2012-01-11
Z-1107-2012		BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was...	Becton Dickinson & Co	LKA	2012-01-11
Z-1089-2012		Streptavidin Alkaline Phosphatase (Ready to Use) Manufactured by: Lab Vision...	Lab Vision Corp.	NJT	2012-01-11
Z-1088-2012		UltraVision Detection System; Anti-Rabbit, Alk-Phos/BCIP/NBT (Ready to...	Lab Vision Corp.	NJT	2012-01-11
Z-1087-2012		UltraVision Plus Large Volume Detection System; Anti-Polyvalent, Alk-Phos (Ready to...	Lab Vision Corp.	NJT	2012-01-11
Z-1086-2012		UltraVision Large Volume Detection System; Anti-Polyvalent, Alk-Phos (Ready to...	Lab Vision Corp.	NJT	2012-01-11
Z-1085-2012		UltraVision Plus Detection System; Anti-Polyvalent, Alk-Phos/Fast Red (Ready to...	Lab Vision Corp.	NJT	2012-01-11
Z-1084-2012		UltraVision Detection System; Anti-Polyvalent, Alk-Phos/Fast Red (Ready to...	Lab Vision Corp.	NJT	2012-01-11
Z-1083-2012		UltraVision Detection System; Anti-Polyvalent, Alk-Phos/BCIP/NBT (Ready to...	Lab Vision Corp.	NJT	2012-01-11
Z-1059-2012		ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM, 017MM, 023MM by varying heights. Dist. By...	Lucero Medical, LLC	MQP	2012-01-11
Z-1111-2012		GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use...	GE Healthcare	KPS	2012-01-11
Z-1110-2012		GE Discovery NM/CT 670 The GE Discovery NM/CT 670 system is a medical tool intended for...	GE Healthcare	KPS	2012-01-11
Z-0158-2020	Class II	Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage...	VitalScientific	JGS	2012-01-10
Z-0157-2020	Class II	Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog #...	VitalScientific	JGS	2012-01-10
Z-0156-2020	Class II	V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry...	VitalScientific	JJF	2012-01-10