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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 666 of 1191

FDA device recalls, page 666 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1255-2015	Class II	RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The...	Siemens Healthcare Diagnostics Inc.	MQM	2014-12-30
Z-1254-2015	Class II	RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The...	Siemens Healthcare Diagnostics Inc.	MQM	2014-12-30
Z-1253-2015	Class II	RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855...	Siemens Healthcare Diagnostics Inc.	MQM	2014-12-30
Z-1252-2015	Class II	RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347...	Siemens Healthcare Diagnostics Inc.	MQM	2014-12-30
Z-1014-2015	Class II	Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile...	Clinical Innovations, LLC	OQY	2014-12-30
Z-1263-2015	Class II	VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following...	Ortho-Clinical Diagnostics, Inc.	N/A	2014-12-29
Z-1003-2015	Class II	Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI...	Dicks Sporting Goods Inc	HST	2014-12-29
Z-1227-2015	Class II	Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product...	Baxter Corporation Englewood	KYX	2014-12-29
Z-1312-2015	Class II	Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425	Advanced Sterilization Products	FRG	2014-12-24
Z-1541-2015	Class II	Portable FAR Infrared Sauna Indications including, but not limited to Natural pain...	Therasage Corporation	N/A	2014-12-23
Z-1540-2015	Class II	FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural...	Therasage Corporation	N/A	2014-12-23
Z-1539-2015	Class II	FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural...	Therasage Corporation	N/A	2014-12-23
Z-1054-2015	Class II	Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate...	Medtronic, Inc.	BSR	2014-12-23
Z-1060-2015	Class II	Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number...	Shape Medical Systems, Inc	BTY	2014-12-23
Z-0219-2016	Class II	HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC...	Philips North America LLC	MKJ	2014-12-23
Z-1077-2015	Class III	Flyte Togas are components of the Stryker Flyte System and are intended to be worn over...	Stryker Corp.	FYA	2014-12-22
Z-1278-2015	Class II	Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile...	Puritan Medical Products Company, LLC	KXG	2014-12-22
Z-1448-2015	Class II	SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml...	Vitrolife Inc.	KTO	2014-12-22
Z-0998-2015	Class II	Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac...	Cordis US Corp.	LIT	2014-12-22
Z-1407-2015	Class II	GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx	GE Healthcare	IZL	2014-12-19
Z-1406-2015	Class II	GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx	GE Healthcare	IZL	2014-12-19
Z-1405-2015	Class II	GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx	GE Healthcare	IZL	2014-12-19
Z-1237-2015	Class II	Monaco radiation therapy treatment planning system. The Monaco system is used to make...	Elekta Limited	MUJ	2014-12-19
Z-1244-2015	Class II	Focal Sim radiation therapy treatment planning system	Elekta Limited	MUJ	2014-12-19
Z-1143-2015	Class II	Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No...	Boston Scientific Corporation	GEI	2014-12-19
Z-1047-2015	Class II	Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A...	Fresenius Medical Care Renal Therapies Group, LLC	KOC	2014-12-19
Z-1313-2015	Class II	Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for...	Synthes GmbH	HWE	2014-12-19
Z-0910-2015	Class II	McKesson Cardiology ECG Management It is a software application designed to import...	Change Healthcare Israel Ltd.	DQK	2014-12-19
Z-1020-2015	Class II	Quickie Q7 Adult Rigid Wheelchair Model EIR4.	Sunrise Medical, Inc.	IOR	2014-12-19
Z-1019-2015	Class II	Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.	Sunrise Medical, Inc.	IOR	2014-12-19
Z-1059-2015	Class II	LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression...	Siemens Medical Solutions USA, Inc.	IYE	2014-12-19
Z-1000-2015	Class II	CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color...	Becton, Dickinson and Company, BD Biosciences	GKL	2014-12-19
Z-1002-2015	Class II	Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow...	Becton, Dickinson and Company, BD Biosciences	MVU	2014-12-19
Z-0977-2015	Class II	lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164	SPINEFRONTIER, Inc. dba LESspine Innovations	LXH	2014-12-19
Z-1084-2015	Class II	The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per package. Product...	Integra LifeSciences Corporation	FWZ	2014-12-19
Z-1032-2015	Class II	HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per...	Fresenius Kabi USA, LLC	NZW	2014-12-19
Z-1055-2015	Class II	BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection...	Becton Dickinson & Co	FMF	2014-12-19
Z-0985-2015	Class II	GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.	GE Healthcare	JAK	2014-12-19
Z-0374-2016	Class II	Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by...	Philips North America LLC	MHX	2014-12-19
Z-0949-2015	Class II	Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M...	Abbott Medical	NVZ	2014-12-18
Z-0999-2015	Class III	cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the...	Roche Molecular Systems Inc	OWD	2014-12-18
Z-1945-2016	Class II	The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated...	Sysmex Corporation	GKZ	2014-12-18
Z-0907-2015	Class II	Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is...	Spinal Elements, Inc	MAX	2014-12-18
Z-0988-2015	Class II	Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic...	Ziemer USA Inc	HQF	2014-12-18
Z-1041-2015	Class II	Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer	Roche Diagnostics GmbH	CGA	2014-12-18
Z-1136-2015	Class II	Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient...	Zimmer GmbH	KWA	2014-12-17
Z-1135-2105	Class II	CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally...	Zimmer GmbH	MEH	2014-12-17
Z-1250-2015	Class II	Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System...	Pivotal Health Solutions	ILY	2014-12-17
Z-1134-2015	Class II	Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction...	Zimmer GmbH	LZO	2014-12-17
Z-1133-2015	Class II	Metasul Femoral Head - A modular head component is used in conjunction with a femoral...	Zimmer GmbH	KWA	2014-12-17