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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 685 of 1191

FDA device recalls, page 685 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0074-2015	Class II	EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000...	Intuitive Surgical, Inc.	NAY	2014-09-18
Z-0048-2015	Class I	Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A	Medtronic, Inc.	DRO	2014-09-18
Z-0047-2015	Class I	MediChoice Multifunction Electrode Part Number: MC171 OH	Medtronic, Inc.	MKJ	2014-09-18
Z-0046-2015	Class I	Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006	Medtronic, Inc.	MKJ	2014-09-18
Z-0045-2015	Class I	Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660	Medtronic, Inc.	DRO	2014-09-18
Z-0044-2015	Class I	Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes...	Medtronic, Inc.	DRO	2014-09-18
Z-0043-2015	Class I	Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes...	Medtronic, Inc.	DRO	2014-09-18
Z-2050-2018	Class II	nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of...	NordicNeuroLab AS	LLZ	2014-09-17
Z-0854-2015	Class II	Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141...	Siemens Medical Solutions USA, Inc.	IZI	2014-09-17
Z-0008-2015	Class I	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power...	Respironics, Inc.	CBK	2014-09-17
Z-0088-2015	Class II	Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the...	Boston Scientific Corporation	LWP	2014-09-17
Z-0087-2015	Class II	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models...	Boston Scientific Corporation	LWP	2014-09-17
Z-0018-2015	Class I	Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store...	Richard-Allan Scientific LLC	LDY	2014-09-17
Z-0017-2015	Class I	Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and...	Richard-Allan Scientific LLC	LDY	2014-09-17
Z-0016-2015	Class I	Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used...	Richard-Allan Scientific LLC	LDY	2014-09-17
Z-0015-2015	Class I	Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to...	Richard-Allan Scientific LLC	LDY	2014-09-17
Z-0014-2015	Class I	Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used...	Richard-Allan Scientific LLC	LDY	2014-09-17
Z-0013-2015	Class I	Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used...	Richard-Allan Scientific LLC	LDY	2014-09-17
Z-0021-2015	Class II	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy...	Zimmer GmbH	HTO	2014-09-17
Z-0012-2015	Class I	Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to...	Richard-Allan Scientific LLC	LDY	2014-09-17
Z-0063-2015	Class II	EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System...	Intuitive Surgical, Inc.	NAY	2014-09-17
Z-0134-2015	Class III	ProClear Toric contact lenses are made from a material containing 62% water and...	COOPERVISION Manufacturing Puerto Rico, LLC	LPL	2014-09-17
Z-0055-2015	Class II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1...	ZOLL Medical Corporation	MKJ	2014-09-16
Z-0054-2015	Class II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part...	ZOLL Medical Corporation	MKJ	2014-09-16
Z-0053-2015	Class II	ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number...	ZOLL Medical Corporation	MKJ	2014-09-16
Z-0052-2015	Class II	ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product...	ZOLL Medical Corporation	MKJ	2014-09-16
Z-0085-2015	Class I	Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid...	Baxter Healthcare Corporation	KPE	2014-09-16
Z-0084-2015	Class I	Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml...	Baxter Healthcare Corporation	KPE	2014-09-16
Z-0841-2015	Class II	GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications...	GE Healthcare	OXO	2014-09-15
Z-0840-2015	Class II	GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications...	GE Healthcare	OXO	2014-09-15
Z-0067-2015	Class II	AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing...	Primus Medical LLC	FNL	2014-09-15
Z-0103-2015	Class II	ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number...	Siemens Healthcare Diagnostics Inc.	LOM	2014-09-15
Z-0102-2015	Class II	Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic...	Siemens Healthcare Diagnostics Inc.	LOM	2014-09-15
Z-0091-2015	Class II	Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog...	Cerenovus, Inc.	JXG	2014-09-15
Z-0090-2015	Class II	Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog...	Cerenovus, Inc.	JXG	2014-09-15
Z-0089-2015	Class II	Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog...	Cerenovus, Inc.	JXG	2014-09-15
Z-0114-2015	Class II	ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia...	Arrow International LLC (subsidiary of Teleflex Incorporated)	CAZ	2014-09-15
Z-2867-2016	Class II	Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be...	Invivo Corporation	MWI	2014-09-14
Z-2044-2018	Class II	nordicICE 2.3.14 Image processing software package used by trained professionals...	NordicNeuroLab AS	LLZ	2014-09-12
Z-0167-2015	Class II	Prescription eyeglass safety lenses. Vision correction	Eyemart Express, LLC	HQG	2014-09-12
Z-0214-2015	Class III	ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro...	Siemens Healthcare Diagnostics Inc.	JJE	2014-09-12
Z-0064-2015	Class III	Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics...	Roche Diagnostics GmbH	CHL	2014-09-12
Z-1073-2017	Class II	MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for...	The Binding Site Group Ltd.	CFN	2014-09-11
Z-1072-2017	Class II	Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ...	The Binding Site Group Ltd.	CFN	2014-09-11
Z-1071-2017	Class II	Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II...	The Binding Site Group Ltd.	CFN	2014-09-11
Z-1070-2017	Class II	Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent...	The Binding Site Group Ltd.	CFN	2014-09-11
Z-1069-2017	Class II	Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is...	The Binding Site Group Ltd.	CFN	2014-09-11
Z-1068-2017	Class II	Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended...	The Binding Site Group Ltd.	CFN	2014-09-11
Z-1067-2017	Class II	Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code...	The Binding Site Group Ltd.	CFN	2014-09-11
Z-0474-2015	Class II	ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL)...	Abbott Ireland Diagnostics Division	CDP	2014-09-11