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 592 of 1191

FDA device recalls, page 592 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1516-2016	Class II	GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number...	Stryker Corp.	HCG	2016-03-21
Z-1571-2016	Class II	Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by...	Hardy Diagnostics	JSJ	2016-03-21
Z-1379-2016	Class II	SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers...	Stryker Corp.	LWH	2016-03-21
Z-1690-2016	Class II	1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of...	Becton Dickinson & Co	FOZ	2016-03-18
Z-1567-2016	Class II	Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X...	Boston Scientific Corporation	JCT	2016-03-18
Z-1393-2016	Class II	RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw...	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWP	2016-03-18
Z-1390-2016	Class III	BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics	Becton, Dickinson and Company, BD Biosciences	GKL	2016-03-18
Z-2083-2016	Class II	Medtronic Navigation O-arm 02 surgical x-ray imaging system	Medtronic Navigation, Inc	OWB	2016-03-17
Z-2082-2016	Class II	Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028	Medtronic Navigation, Inc	OXO	2016-03-17
Z-1666-2016	Class II	Dimension Vista Assays: Uric Acid (URCA)	Siemens Healthcare Diagnostics Inc.	KNK	2016-03-17
Z-1665-2016	Class II	Dimension Vista Assays: Triglycerides (TRIG)	Siemens Healthcare Diagnostics Inc.	CDT	2016-03-17
Z-1664-2016	Class II	Dimension Vista Assays: Enzymatic Creatine (ECRE)	Siemens Healthcare Diagnostics Inc.	JFY	2016-03-17
Z-1663-2016	Class II	Dimension Vista Assays: Direct HDL Cholesterol (AHDL)	Siemens Healthcare Diagnostics Inc.	JHM	2016-03-17
Z-1662-2016	Class II	Dimension Assays: Uric Acid (URCA)	Siemens Healthcare Diagnostics Inc.	KNK	2016-03-17
Z-1661-2016	Class II	Dimension Assays: Triglycerides (TGL)	Siemens Healthcare Diagnostics Inc.	CDT	2016-03-17
Z-1660-2016	Class II	Dimension Assays: ENZYMATIC CREATININE	Siemens Healthcare Diagnostics Inc.	JFY	2016-03-17
Z-1659-2016	Class II	Dimension Assays: Direct HDL Cholesterol (AHDL)	Siemens Healthcare Diagnostics Inc.	JHM	2016-03-17
Z-1658-2016	Class II	Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated	Siemens Healthcare Diagnostics Inc.	KNK	2016-03-17
Z-1657-2016	Class II	ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2...	Siemens Healthcare Diagnostics Inc.	CDT	2016-03-17
Z-1656-2016	Class II	Advia Chemistry Assay: Lactate	Siemens Healthcare Diagnostics Inc.	CFJ	2016-03-17
Z-1655-2016	Class II	ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose...	Siemens Healthcare Diagnostics Inc.	CGA	2016-03-17
Z-1654-2016	Class II	Advia Chemistry Enzymatic Creatinine_2	Siemens Healthcare Diagnostics Inc.	JFY	2016-03-17
Z-1653-2016	Class II	Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)	Siemens Healthcare Diagnostics Inc.	LBS	2016-03-17
Z-1652-2016	Class II	Advia Chemistry Assay: LDL Cholesterol, Direct	Siemens Healthcare Diagnostics Inc.	MRR	2016-03-17
Z-1651-2016	Class II	Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol	Siemens Healthcare Diagnostics Inc.	CHH	2016-03-17
Z-1569-2016	Class II	enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module...	Ortho-Clinical Diagnostics, Inc.	JJE	2016-03-17
Z-1389-2016	Class III	Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning...	Madison Polymeric Engineering	MNL	2016-03-17
Z-1341-2016	Class II	Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left...	Zimmer Manufacturing B.V.	JWH	2016-03-17
Z-1340-2016	Class II	Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left...	Zimmer Manufacturing B.V.	JWH	2016-03-17
Z-2738-2016	Class II	PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP"...	Terumo Medical Corp.	DYB	2016-03-16
Z-1377-2016	Class II	da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The...	Intuitive Surgical, Inc.	NAY	2016-03-16
Z-1376-2016	Class II	da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument &...	Intuitive Surgical, Inc.	NAY	2016-03-16
Z-1498-2016	Class II	iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA...	Optovue Inc.	HLI	2016-03-16
Z-0741-2020	Class II	PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or...	Polymer Technology Systems	NBW	2016-03-15
Z-0376-2017	Class II	Philips Healthcare System X-ray Tomography Computed :	Philips North America LLC	JAK	2016-03-15
Z-0375-2017	Class II	Philips Healthcare System X-ray Tomography Computed :	Philips North America LLC	JAK	2016-03-15
Z-2402-2016	Class II	Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to...	Invacare GmbH	FNL	2016-03-15
Z-2401-2016	Class II	Invacare Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The...	Invacare GmbH	FNL	2016-03-15
Z-2400-2016	Class II	Invacare Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The...	Invacare GmbH	FNL	2016-03-15
Z-1880-2016	Class II	STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas...	Salter Labs	CCK	2016-03-15
Z-1830-2016	Class II	cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation...	Roche Molecular Systems Inc	OWD	2016-03-15
Z-1845-2016	Class II	EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system...	OLYMPUS Corporation of the Americas	FDT	2016-03-15
Z-1375-2016	Class II	Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the...	Merit Medical Systems, Inc.	DRC	2016-03-15
Z-1562-2016	Class II	GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia...	GE Healthcare	BSZ	2016-03-15
Z-1529-2016	Class II	MEVION S250 for Proton Radiation Therapy	Mevion Medical Systems, Inc.	LHN	2016-03-15
Z-2399-2016	Class II	Invacare Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The...	Invacare GmbH	FNL	2016-03-15
Z-1988-2016	Class II	BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN...	Boston Scientific Corporation	LJS	2016-03-14
Z-1987-2016	Class II	BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN...	Boston Scientific Corporation	LJS	2016-03-14
Z-1986-2016	Class II	BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410...	Boston Scientific Corporation	LJS	2016-03-14
Z-1985-2016	Class II	BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN...	Boston Scientific Corporation	LJS	2016-03-14