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 788 of 1190

FDA device recalls, page 788 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1948-2012	Class II	Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street...	Arjo, Inc.	FSA	2012-06-29
Z-1947-2012	Class II	Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street...	Arjo, Inc.	FSA	2012-06-29
Z-1137-2013	Class II	GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that...	GE Healthcare	LLZ	2012-06-28
Z-2211-2012	Class II	VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box...	Ortho-Clinical Diagnostics, Inc.	LFM	2012-06-28
Z-2100-2012	Class II	STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as...	Advanced Sterilization Products	FRC	2012-06-28
Z-1201-2014	Class II	Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.	Evoqua Water Technologies LLC	FIP	2012-06-27
Z-0409-2013	Class II	RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary...	KCI USA, Inc.	IOQ	2012-06-27
Z-2121-2012	Class II	Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage...	Revvity Health Sciences, Inc.	JLW	2012-06-27
Z-1979-2012	Class II	Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product...	Abbott Medical	LGZ	2012-06-27
Z-2249-2012	Class II	Powered Mobility Offers Versatility (MV)TM Chair. The Powered MOV Chair models EMS...	Stryker Medical	ILK	2012-06-27
Z-2248-2012	Class II	Powered Mobility Offers Versatility (MV)TM Chair. The Powered MOV Chair models EMS...	Stryker Medical	ILK	2012-06-27
Z-2247-2012	Class II	Powered Mobility Offers Versatility (MV)TM Chair The Powered MOV Chair models EMS...	Stryker Medical	ILK	2012-06-27
Z-2246-2012	Class II	Powered Mobility Offers Versatility (MV)TM Chair The Powered MOV Chair models EMS...	Stryker Medical	ILK	2012-06-27
Z-0494-2013	Class II	GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended...	GE Healthcare	MHX	2012-06-26
Z-0606-2013	Class I	GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient...	GE Healthcare	BTL	2012-06-26
Z-0068-2013	Class II	NP211H*2009-02CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA** To...	Linvatec Corporation	MBI	2012-06-26
Z-0067-2013	Class II	"*PressFT2.1 w/ One #2 (5 metric) Hi-FiSutureNP2112009-02*CONMED LINVATEC...	Linvatec Corporation	MBI	2012-06-26
Z-0066-2013	Class II	"*PressFT2.1 w/ Two #0 (3.5 metric) Hi-FiSuturesNP2122009-02*CONMED...	Linvatec Corporation	MBI	2012-06-26
Z-0065-2013	Class II	"*Press FT2.6 w/ One #2 (5 metric) Hi-FiSuture, HIPN22009-02*CONMED...	Linvatec Corporation	MBI	2012-06-26
Z-0064-2013	Class II	"*PressFT2.6 w/ One #2 (5 metric) Hi-FiSutureNP2612009-02*CONMED LINVATEC...	Linvatec Corporation	MBI	2012-06-26
Z-0063-2013	Class II	"*PressFT2.6 w/ Two #1 (4 metric) Hi-FiSuturesNP2622009-02*CONMED...	Linvatec Corporation	MBI	2012-06-26
Z-2113-2012	Class II	Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4)...	Sunrise Medical, Inc.	IOR	2012-06-26
Z-2074-2012	Class II	BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide...	Boston Scientific Corporation	DQY	2012-06-26
Z-2073-2012	Class II	ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ...	Siemens Medical Solutions USA, Inc.	IYE	2012-06-25
Z-1971-2012	Class II	System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-25
Z-1970-2012	Class II	System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-25
Z-1969-2012	Class II	System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-25
Z-1968-2012	Class II	System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-25
Z-2056-2012	Class II	System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-22
Z-2055-2012	Class II	System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-22
Z-1958-2012	Class II	Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-22
Z-1966-2012	Class II	System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-22
Z-1965-2012	Class II	System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-22
Z-1964-2012	Class II	Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-22
Z-1963-2012	Class II	Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-22
Z-1962-2012	Class II	Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-22
Z-1957-2012	Class II	Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-22
Z-2007-2012	Class II	Monaco Product Usage: Planning of radiation therapy	Elekta Limited	MUJ	2012-06-21
Z-2002-2012	Class II	Focal SIM Planning of radiation therapy	Elekta Limited	MUJ	2012-06-21
Z-2010-2012	Class II	Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-21
Z-2009-2012	Class II	Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-21
Z-2021-2012	Class II	System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-21
Z-2020-2012	Class II	System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-21
Z-0295-2013	Class II	Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large...	Gulf South Medical Supply Inc	LYZ	2012-06-20
Z-0465-2013	Class II	Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image...	Siemens Medical Solutions USA, Inc.	LLZ	2012-06-20
Z-2218-2012	Class III	System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-20
Z-1986-2012	Class II	Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart...	Philips North America LLC	MKJ	2012-06-20
Z-1896-2012	Class II	Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5...	Philips North America LLC	MKJ	2012-06-20
Z-2347-2012	Class II	Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M...	Philips North America LLC	MKJ	2012-06-20
Z-0969-2013	Class II	Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with...	Molded Products Inc	KOC	2012-06-19