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 687 of 1191

FDA device recalls, page 687 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0038-2015	Class II	RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment...	Depuy Orthopaedics Inc.	LXH	2014-09-03
Z-0005-2015	Class II	Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal...	Siemens Medical Solutions USA, Inc.	KPR	2014-09-02
Z-0004-2015	Class II	Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector...	Siemens Medical Solutions USA, Inc.	KPR	2014-09-02
Z-0003-2015	Class II	Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a...	Siemens Medical Solutions USA, Inc.	KPR	2014-09-02
Z-0121-2015	Class II	The Aeroneb Professional Nebulizer System is a portable medical device for multiple...	Aerogen Ltd.	CAF	2014-09-02
Z-0120-2015	Class II	The Aeroneb Professional Nebulizer System is a portable medical device for multiple...	Aerogen Ltd.	CAF	2014-09-02
Z-0002-2015	Class II	Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics...	Siemens Medical Solutions USA, Inc.	KPR	2014-09-02
Z-0119-2015	Class II	The Aeroneb Professional Nebulizer System is a portable medical device for multiple...	Aerogen Ltd.	CAF	2014-09-02
Z-0118-2015	Class II	The Aeroneb Professional Nebulizer System is a portable medical device for multiple...	Aerogen Ltd.	CAF	2014-09-02
Z-2674-2014	Class II	DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part...	Synthes GmbH	KWQ	2014-09-02
Z-1463-2015	Class II	Fluid Management System P4000; for irrigation and fluid warming in laparoscopic...	Thermedx LLC	HIG	2014-09-01
Z-1247-2015	Class II	Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for...	Arjohuntleigh AB	IKY	2014-09-01
Z-2708-2014	Class II	Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product...	Agilent Technologies, Inc.	KPA	2014-08-29
Z-0068-2015	Class II	eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS...	Merge Healthcare Incorporated	LLZ	2014-08-28
Z-0113-2015	Class II	Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed...	Vygon U.S.A.	FOZ	2014-08-28
Z-0024-2015	Class II	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product...	Siemens Healthcare Diagnostics Inc.	JIT	2014-08-28
Z-2657-2014	Class II	TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning...	Motion Concepts LP	ITI	2014-08-28
Z-0042-2015	Class II	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring...	Mckesson Information Solutions, LLC	MWI	2014-08-27
Z-0100-2015	Class II	GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly...	Gyrus ACMI, Inc.	GEI	2014-08-27
Z-2680-2014	Class II	The Ysio Systems with software version VC10 The Ysio enables radiographic and...	Siemens Medical Solutions USA, Inc.	KPR	2014-08-27
Z-2691-2014	Class II	Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a...	Bolder Surgical, LLC	GDW	2014-08-27
Z-2690-2014	Class II	Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only...	Bolder Surgical, LLC	GDW	2014-08-27
Z-0061-2015	Class II	Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The...	Depuy Orthopaedics Inc.	MDM	2014-08-27
Z-1076-2015	Class II	The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01)...	MAST Biosurgery USA, Inc	FTL	2014-08-26
Z-2707-2014	Class II	Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia...	GE Healthcare	MHX	2014-08-26
Z-2660-2014	Class II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part...	ZOLL Medical Corporation	MKJ	2014-08-26
Z-2659-2014	Class II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number...	ZOLL Medical Corporation	MKJ	2014-08-26
Z-2658-2014	Class II	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE...	ZOLL Medical Corporation	MKJ	2014-08-26
Z-2648-2014	Class II	Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037...	Bard Peripheral Vascular Inc	GDF	2014-08-26
Z-1414-2017	Class II	EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in...	Becton Dickinson & Co	JQP	2014-08-25
Z-2651-2014	Class II	Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a...	Siemens Healthcare Diagnostics Inc.	GIF	2014-08-25
Z-0036-2015	Class II	PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology...	Boston Scientific Corporation	LJS	2014-08-25
Z-0035-2015	Class II	PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL...	Boston Scientific Corporation	LJS	2014-08-25
Z-0034-2015	Class II	PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN...	Boston Scientific Corporation	LJS	2014-08-25
Z-0033-2015	Class II	PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology...	Boston Scientific Corporation	LJS	2014-08-25
Z-0032-2015	Class II	PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL...	Boston Scientific Corporation	LJS	2014-08-25
Z-0031-2015	Class II	PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology...	Boston Scientific Corporation	LJS	2014-08-25
Z-0030-2015	Class II	PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology...	Boston Scientific Corporation	LJS	2014-08-25
Z-0029-2015	Class II	PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology...	Boston Scientific Corporation	LJS	2014-08-25
Z-0028-2015	Class II	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No...	Boston Scientific Corporation	LJS	2014-08-25
Z-0027-2015	Class II	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No...	Boston Scientific Corporation	LJS	2014-08-25
Z-0026-2015	Class II	BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit...	Boston Scientific Corporation	LJS	2014-08-25
Z-0025-2015	Class II	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No...	Boston Scientific Corporation	LJS	2014-08-25
Z-0098-2015	Class II	DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE...	DeRoyal Industries, Inc.	KDQ	2014-08-22
Z-0097-2015	Class II	Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID...	DeRoyal Industries, Inc.	KDQ	2014-08-22
Z-0993-2015	Class II	TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration...	Maquet Cardiovascular Us Sales, LLC	OUG	2014-08-21
Z-0325-2016	Class II	Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and...	Philips North America LLC	LNH	2014-08-21
Z-2687-2014	Class II	UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the...	Siemens Healthcare Diagnostics Inc.	JJE	2014-08-21
Z-1201-2017	Class II	Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable...	Terumo Cardiovascular Systems Corporation	MWS	2014-08-20
Z-0007-2015	Class II	VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For...	Ortho-Clinical Diagnostics, Inc.	DIP	2014-08-20