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 724 of 1191

FDA device recalls, page 724 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0936-2015	Class II	Cervical Extension Machine for Physical Therapy	MedX Holdings, Inc.	IKK	2013-12-03
Z-0935-2015	Class II	Lumbar Extension Machine for Physical Therapy	MedX Holdings, Inc.	ISD	2013-12-03
Z-1629-2014	Class II	Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of...	The Anspach Effort, Inc.	FRN	2013-12-03
Z-0539-2014	Class II	ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition)...	Baxter Corporation Englewood	LNX	2013-12-03
Z-1930-2014	Class III	MAS Omni Immune PRO Controls	Microgenics Corporation	JJY	2013-12-02
Z-1929-2014	Class III	MAS Omni Immune Controls	Microgenics Corporation	JJY	2013-12-02
Z-0580-2014	Class II	steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray...	EOS imaging	LLZ	2013-11-29
Z-0982-2014	Class II	GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking...	GE Healthcare	MHX	2013-11-27
Z-0747-2014	Class II	GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended...	GE Healthcare	MHX	2013-11-27
Z-0772-2014	Class II	BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically...	Becton Dickinson & Co	FGY	2013-11-26
Z-0602-2014	Class II	Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences...	Integra LifeSciences Corporation	GWM	2013-11-26
Z-0628-2014	Class II	REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL...	Materialise USA, LLC.	HRY	2013-11-26
Z-0524-2014	Class II	InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation...	GE Healthcare	LLZ	2013-11-26
Z-0604-2014	Class II	STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a...	Advanced Sterilization Products	FRC	2013-11-26
Z-0855-2014	Class II	Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product...	Orthofix SRL	KWP	2013-11-26
Z-0523-2014	Class II	outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use...	Zimmer GmbH	HTD	2013-11-26
Z-0985-2014	Class II	UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an...	Siemens Healthcare Diagnostics Inc.	JJE	2013-11-26
Z-0984-2014	Class II	Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro...	Siemens Healthcare Diagnostics Inc.	JJE	2013-11-26
Z-0551-2014	Class II	Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits...	Integra Pain Management	JXG	2013-11-26
Z-0618-2014	Class II	S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg...	Stryker Medical	FNL	2013-11-26
Z-0617-2014	Class II	Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the...	Stryker Medical	FNL	2013-11-26
Z-1059-2014	Class II	Synergy XVI XVI can incorrectly calculate the target position of the treatment table...	Elekta Limited	IYE	2013-11-25
Z-1061-2014	Class II	Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment...	Elekta Limited	IYE	2013-11-25
Z-0928-2014	Class II	XiO RTP System. Used to create treatment plans for any cancer patient for whom external...	Elekta Limited	MUJ	2013-11-25
Z-1082-2014	Class II	Desktop Pro TM linear accelerator control software intended to assist a licensed...	Elekta Limited	IYE	2013-11-25
Z-1081-2014	Class II	RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is...	Elekta Limited	IYE	2013-11-25
Z-1085-2014	Class II	Agility. Version 3.1 of the Integrity interface and control software for the Elekta range...	Elekta Limited	IYE	2013-11-25
Z-1084-2014	Class II	Agility. Version 3.0 of the Integrity interface and control software for the Elekta range...	Elekta Limited	IYE	2013-11-25
Z-1083-2014	Class II	Integrity. Version 1.1 of the Integrity interface and control software for the Elekta...	Elekta Limited	IYE	2013-11-25
Z-0826-2014	Class II	Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F...	Boston Scientific Corporation	FPA	2013-11-25
Z-0780-2014	Class II	XiO RTP System The XiO RTP System is used to create treatment plans for any cancer...	Elekta Limited	MUJ	2013-11-25
Z-0798-2014	Class II	DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems...	Eastman Kodak Company	IZL	2013-11-25
Z-0797-2014	Class II	DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray...	Eastman Kodak Company	IZL	2013-11-25
Z-0796-2014	Class II	DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray...	Eastman Kodak Company	IZL	2013-11-25
Z-0581-2014	Class II	REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY...	Smith & Nephew, Inc.	LPH	2013-11-25
Z-0558-2014	Class II	HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT...	Abbott Vascular	DQX	2013-11-25
Z-0531-2014	Class I	Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of...	C.L.R. Medicals International, Inc.	LZP	2013-11-25
Z-0948-2015	Class II	The Abbott m2000sp is an automated system for performing sample preparation for nucleic...	Abbott Molecular, Inc.	JJH	2013-11-23
Z-0809-2014	Class II	Pulmonary Hemi-Artery SG Used in heart surgery	Artivion, Inc.	DXZ	2013-11-22
Z-0540-2014	Class II	Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed...	Abbott Medical	FRN	2013-11-22
Z-1192-2014	Class II	G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with...	Abbott Medical	JKA	2013-11-22
Z-1191-2014	Class II	G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5...	Abbott Medical	JKA	2013-11-22
Z-1190-2014	Class II	G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with...	Abbott Medical	JKA	2013-11-22
Z-1189-2014	Class II	G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with...	Abbott Medical	JKA	2013-11-22
Z-1188-2014	Class II	G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with...	Abbott Medical	JKA	2013-11-22
Z-1187-2014	Class II	4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with...	Abbott Medical	JKA	2013-11-22
Z-1186-2014	Class II	4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with...	Abbott Medical	JKA	2013-11-22
Z-1185-2014	Class II	4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with...	Abbott Medical	JKA	2013-11-22
Z-1184-2014	Class II	4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with...	Abbott Medical	JKA	2013-11-22
Z-1183-2014	Class II	4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with...	Abbott Medical	JKA	2013-11-22