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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 699 of 1191

FDA device recalls, page 699 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1761-2014	Class II	Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended...	Stryker Corp.	HBE	2014-05-22
Z-1760-2014	Class II	Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1759-2014	Class II	Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1758-2014	Class II	Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1757-2014	Class II	Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1756-2014	Class II	Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1755-2014	Class II	Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1754-2014	Class II	Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are...	Stryker Corp.	HBE	2014-05-22
Z-1753-2014	Class II	Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be...	Stryker Corp.	HBE	2014-05-22
Z-1752-2014	Class II	Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be...	Stryker Corp.	HBE	2014-05-22
Z-1751-2014	Class II	Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be...	Stryker Corp.	HBE	2014-05-22
Z-1750-2014	Class II	Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be...	Stryker Corp.	HBE	2014-05-22
Z-1746-2014	Class II	IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information...	Philips North America LLC	MHX	2014-05-22
Z-1749-2014	Class II	Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be...	Stryker Corp.	HBE	2014-05-22
Z-2213-2014	Class II	Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative...	Brainlab, Inc.	HAW	2014-05-21
Z-1975-2014	Class II	Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1974-2014	Class II	Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1973-2014	Class II	Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1972-2014	Class II	IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1971-2014	Class II	Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1970-2014	Class II	Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1969-2014	Class II	Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1968-2014	Class II	Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1967-2014	Class II	Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1966-2014	Class II	Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1965-2014	Class II	Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-1964-2014	Class II	System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci...	Intuitive Surgical, Inc.	NAY	2014-05-21
Z-2041-2014	Class III	BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number...	Becton Dickinson & Co	JSS	2014-05-21
Z-1841-2014	Class II	Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical...	Seaspine, Inc.	NKB	2014-05-21
Z-1732-2014	Class II	RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical...	Teleflex Medical	KOD	2014-05-21
Z-1792-2014	Class II	cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat...	Roche Diagnostics GmbH	JJE	2014-05-21
Z-1791-2014	Class II	cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat...	Roche Diagnostics GmbH	JJE	2014-05-21
Z-1790-2014	Class II	Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version...	Roche Diagnostics GmbH	JJE	2014-05-21
Z-1038-2015	Class II	SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system...	SCC Soft Computer	JQP	2014-05-20
Z-2534-2014	Class I	Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN...	Customed, Inc	LRO	2014-05-20
Z-2533-2014	Class I	LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL...	Customed, Inc	FDE	2014-05-20
Z-2532-2014	Class I	Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR...	Customed, Inc	OFA	2014-05-20
Z-2531-2014	Class I	Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1)...	Customed, Inc	OFA	2014-05-20
Z-2530-2014	Class I	Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN...	Customed, Inc	LRO	2014-05-20
Z-2529-2014	Class I	Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL...	Customed, Inc	LRO	2014-05-20
Z-2528-2014	Class I	Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE...	Customed, Inc	FDE	2014-05-20
Z-2527-2014	Class I	Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL...	Customed, Inc	LRO	2014-05-20
Z-2526-2014	Class I	Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL...	Customed, Inc	LRO	2014-05-20
Z-2525-2014	Class I	Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED...	Customed, Inc	LRO	2014-05-20
Z-2524-2014	Class I	Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED...	Customed, Inc	LRO	2014-05-20
Z-2523-2014	Class I	General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINFORCED...	Customed, Inc	LRO	2014-05-20
Z-2522-2014	Class I	Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE...	Customed, Inc	LRO	2014-05-20
Z-2521-2014	Class I	Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI...	Customed, Inc	LRO	2014-05-20
Z-2520-2014	Class I	Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI...	Customed, Inc	LRO	2014-05-20
Z-2519-2014	Class I	Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI...	Customed, Inc	LRO	2014-05-20