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 537 of 1191

FDA device recalls, page 537 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1543-2017	Class II	Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers...	Medtronic, Inc.	MIH	2017-02-27
Z-1454-2017	Class II	Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343	Corentec Co., Ltd.	LPH	2017-02-27
Z-1777-2017	Class II	Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in...	Welch Allyn Inc	DXN	2017-02-27
Z-0561-2019	Class II	Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8...	Helena Laboratories, Corp.	JPB	2017-02-24
Z-1753-2017	Class II	BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras...	Philips North America LLC	KPS	2017-02-24
Z-1752-2017	Class II	BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras...	Philips North America LLC	KPS	2017-02-24
Z-1751-2017	Class II	BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed...	Philips North America LLC	KPS	2017-02-24
Z-1750-2017	Class II	BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras...	Philips North America LLC	KPS	2017-02-24
Z-1417-2017	Class I	HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ)...	Philips North America LLC	MKJ	2017-02-24
Z-1426-2018	Class II	Thoracentesis/ Paracentesis Kit 10/CS; STERILE;	Medtronic, Inc.	FSH	2017-02-23
Z-1425-2018	Class II	JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6...	Medtronic, Inc.	FSH	2017-02-23
Z-1424-2018	Class II	JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.)...	Medtronic, Inc.	FSH	2017-02-23
Z-1423-2018	Class II	Illinois (Tj) Needle Aspiration [15Ga, 18Ga]; Sterile;	Medtronic, Inc.	FSH	2017-02-23
Z-1422-2018	Class II	Jamshidi Needle Biopsy [15G X 100Mm Disp, 16G X 100Mm Disp, 17G X 100Mm, 16G X 70Mm...	Medtronic, Inc.	FSH	2017-02-23
Z-1893-2017	Class II	Ziehm Imaging solo FD Mobile Fluoroscopic C-arm	Ziehm Imaging GmbH	OWB	2017-02-23
Z-1712-2017	Class III	ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays...	Siemens Healthcare Diagnostics Inc.	JIS	2017-02-23
Z-1493-2017	Class II	Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to...	Philips North America LLC	JAK	2017-02-23
Z-1492-2017	Class II	Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to...	Philips North America LLC	JAK	2017-02-23
Z-1536-2017	Class II	9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power...	Medical Components, Inc.	LJT	2017-02-23
Z-1421-2018	Class II	Manometer, 550 ml three-Way Stopcock; STERILE;	Medtronic, Inc.	KRK	2017-02-23
Z-1816-2017	Class II	TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient...	Hill-Rom Inc.	FNL	2017-02-23
Z-1684-2017	Class II	Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD...	Streck LLC	GIM	2017-02-23
Z-1534-2017	Class II	ARTIS Q, Interventional Fluroscopic x-ray system	Siemens Medical Solutions USA, Inc.	OWB	2017-02-22
Z-1835-2017	Class II	INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product...	Ace Surgical Supply Co., Inc.	DZE	2017-02-22
Z-1702-2017	Class I	The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous...	Medtronic Neurosurgery	JXG	2017-02-22
Z-1469-2017	Class II	OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems	GE Healthcare	OXO	2017-02-21
Z-1407-2017	Class II	MicroAire K-Wires	MicroAire Surgical Instruments, LLC	HTY	2017-02-21
Z-1887-2017	Class II	VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No...	Ortho-Clinical Diagnostics, Inc.	LEH	2017-02-21
Z-1516-2017	Class II	Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly...	Medtronic Sofamor Danek USA Inc	JWH	2017-02-20
Z-1515-2017	Class II	Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly...	Medtronic Sofamor Danek USA Inc	JWH	2017-02-20
Z-1514-2017	Class II	Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly...	Medtronic Sofamor Danek USA Inc	JWH	2017-02-20
Z-1513-2017	Class II	Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly...	Medtronic Sofamor Danek USA Inc	JWH	2017-02-20
Z-1533-2017	Class II	Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture...	Siemens Medical Solutions USA, Inc.	LLZ	2017-02-20
Z-1484-2017	Class II	AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to...	Vygon Mfg	FPA	2017-02-20
Z-1834-2017	Class II	Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090	Whiteside Biomechanics, Inc.	GFJ	2017-02-20
Z-1868-2017	Class II	SmartTools Knee System Orthopedic Stereotaxic Instrument	Zimmer CAS	OLO	2017-02-20
Z-1459-2017	Class II	Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor...	Terumo Cardiovascular Systems Corporation	DTQ	2017-02-20
Z-1458-2017	Class II	Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic...	Terumo Cardiovascular Systems Corporation	DTQ	2017-02-20
Z-1482-2017	Class II	MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension...	CareFusion 303, Inc	FPA	2017-02-20
Z-1464-2017	Class II	MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305	CareFusion 303, Inc	FPA	2017-02-20
Z-1425-2017	Class II	Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs...	Siemens Medical Solutions USA, Inc.	KPS	2017-02-20
Z-1424-2017	Class II	Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are...	Siemens Medical Solutions USA, Inc.	KPS	2017-02-20
Z-1423-2017	Class II	Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended...	Siemens Medical Solutions USA, Inc.	KPS	2017-02-20
Z-1422-2017	Class II	Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended...	Siemens Medical Solutions USA, Inc.	KPS	2017-02-20
Z-2706-2017	Class II	Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to...	FUJIFILM Healthcare Americas Corporation	FDS	2017-02-17
Z-1863-2017	Class II	various polyethylene implants Sports Med Repicci II Tibial Components Product...	Zimmer GmbH	HRY	2017-02-17
Z-1862-2017	Class II	various polyethylene implants Custom parts Product Usage: Custom	Zimmer GmbH	N/A	2017-02-17
Z-1861-2017	Class II	various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial...	Zimmer GmbH	JWH	2017-02-17
Z-1860-2017	Class II	various polyethylene implants Hips Active Articulation ArComXL Bearings Active...	Zimmer GmbH	JDI	2017-02-17
Z-1859-2017	Class II	various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder...	Zimmer GmbH	KWS	2017-02-17