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 470 of 1191

FDA device recalls, page 470 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2438-2018	Class II	Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586	Siemens Healthcare Diagnostics Inc.	CDZ	2018-03-21
Z-2437-2018	Class II	Dimension Vista MULTI 1 SDIL, KD693, SMN# 10469971	Siemens Healthcare Diagnostics Inc.	CHP	2018-03-21
Z-2436-2018	Class II	Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205	Siemens Healthcare Diagnostics Inc.	MMI	2018-03-21
Z-1875-2018	Class II	Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm...	Epic Extremity, LLC	HRS	2018-03-20
Z-1874-2018	Class II	Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended...	Epic Extremity, LLC	HRS	2018-03-20
Z-1533-2018	Class II	BD Vacutainer Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x...	Becton Dickinson & Co	JKA	2018-03-20
Z-1532-2018	Class II	BD Vacutainer Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x x 12 Catalog...	Becton Dickinson & Co	JKA	2018-03-20
Z-1531-2018	Class II	BD Vacutainer Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x x 12...	Becton Dickinson & Co	JKA	2018-03-20
Z-1353-2018	Class II	First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet...	Certified Safety Mfg Inc	LRR	2018-03-20
Z-2200-2019	Class II	HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro...	Hycor Biomedical	DHR	2018-03-19
Z-1514-2018	Class II	Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and...	Synthes GmbH	HWB	2018-03-19
Z-1628-2018	Class II	Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700...	Teleflex Medical	CCT	2018-03-19
Z-2529-2018	Class II	Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product...	Nobel Biocare USA LLC	NHA	2018-03-16
Z-1442-2018	Class II	T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce...	Philips North America LLC	LNH	2018-03-16
Z-1441-2018	Class II	Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet...	Philips North America LLC	LNH	2018-03-16
Z-1440-2018	Class II	T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can...	Philips North America LLC	LNH	2018-03-16
Z-1439-2018	Class II	ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can...	Philips North America LLC	LNH	2018-03-16
Z-1395-2018	Class II	GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626...	GE Healthcare	KGI	2018-03-16
Z-1394-2018	Class II	GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX...	GE Healthcare	KGI	2018-03-16
Z-1393-2018	Class II	GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number...	GE Healthcare	KGI	2018-03-16
Z-1418-2018	Class II	Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI...	Terumo Cardiovascular Systems Corporation	DWC	2018-03-16
Z-1417-2018	Class II	Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring...	Terumo Cardiovascular Systems Corporation	DWC	2018-03-16
Z-1416-2018	Class II	Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature...	Terumo Cardiovascular Systems Corporation	DWC	2018-03-16
Z-1438-2018	Class II	T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can...	Philips North America LLC	LNH	2018-03-16
Z-1437-2018	Class II	Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic...	Philips North America LLC	LNH	2018-03-16
Z-1436-2018	Class II	Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use...	Philips North America LLC	LNH	2018-03-16
Z-1435-2018	Class II	Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178...	Philips North America LLC	LNH	2018-03-16
Z-1434-2018	Class II	Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It...	Philips North America LLC	LNH	2018-03-16
Z-1433-2018	Class II	Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model...	Philips North America LLC	LNH	2018-03-16
Z-1432-2018	Class II	Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated...	Philips North America LLC	LNH	2018-03-16
Z-1431-2018	Class II	Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic...	Philips North America LLC	LNH	2018-03-16
Z-1430-2018	Class II	Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073...	Philips North America LLC	LNH	2018-03-16
Z-3198-2018	Class II	URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which...	Biocare Medical LLC	NJT	2018-03-15
Z-2427-2018	Class II	LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar...	Medtronic, Inc.	FTL	2018-03-15
Z-1370-2018	Class II	Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b)...	Teleflex Medical	KNT	2018-03-15
Z-1369-2018	Class II	Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a)...	Teleflex Medical	GBM	2018-03-15
Z-1368-2018	Class II	Rectal Catheters; Product Code Equivalent Code 580114 580114 Product...	Teleflex Medical	FAP	2018-03-15
Z-1367-2018	Class II	Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b)...	Teleflex Medical	BTC	2018-03-15
Z-1360-2018	Class II	Normed Charcot Osteotome Chisel (Various sizes)	Zimmer GmbH	KDG	2018-03-15
Z-1917-2018	Class II	ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part...	Implant Direct Sybron Manufacturing LLC	DZE	2018-03-14
Z-1589-2018	Class II	Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor)...	Philips North America LLC	OWB	2018-03-14
Z-1543-2018	Class II	PTS Panels CHOL+GLU Test Strips (REF 1765)	Polymer Technology Systems	NBW	2018-03-14
Z-1529-2018	Class II	Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate...	Accelerate Diagnostics, Inc.	PRH	2018-03-14
Z-1867-2018	Class II	PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901...	Invivo Corporation	MWI	2018-03-14
Z-1376-2018	Class II	WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm...	Wright Medical Technology Inc	HSB	2018-03-14
Z-1375-2018	Class II	WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm...	Wright Medical Technology Inc	HSB	2018-03-14
Z-1513-2018	Class II	FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126...	BioFire Diagnostics, LLC	PEN	2018-03-14
Z-1914-2018	Class II	Philips HeartStart (HS1) Onsite/Home AED	Philips North America LLC	MKJ	2018-03-14
Z-1913-2018	Class II	Philips HeartStart FRx AED.	Philips North America LLC	MKJ	2018-03-14
Z-1919-2018	Class II	Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The...	LivaNova USA, Inc.	DTZ	2018-03-13