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 743 of 1191

FDA device recalls, page 743 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2060-2013	Class II	TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem...	Waldemar Link GmbH & Co. KG (Corp. Hq.)	HWT	2013-07-16
Z-2083-2013	Class II	BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate...	Brainlab, Inc.	IYE	2013-07-16
Z-1972-2013	Class II	Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort...	Edwards Lifesciences LLC	DWF	2013-07-16
Z-1987-2013	Class II	PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated...	Atrium Medical Corporation	KDQ	2013-07-16
Z-1145-2014	Class II	Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical...	China Daheng Group, Inc.	LYB	2013-07-15
Z-2265-2013	Class II	ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic...	Endoplus	GCJ	2013-07-15
Z-2264-2013	Class II	ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic...	Endoplus	GCJ	2013-07-15
Z-1906-2013	Class I	Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number...	Nova Biomedical Corporation	NBW	2013-07-15
Z-1905-2013	Class I	Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product...	Nova Biomedical Corporation	NBW	2013-07-15
Z-1904-2013	Class I	Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max...	Nova Biomedical Corporation	NBW	2013-07-15
Z-2190-2013	Class II	HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue...	HemoCue AB	CGA	2013-07-15
Z-1979-2013	Class II	Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter...	Boston Scientific Corporation	LWS	2013-07-15
Z-2113-2013	Class II	DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx...	DeRoyal Industries, Inc.	NKC	2013-07-15
Z-1956-2013	Class II	StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical...	Medtronic Navigation, Inc	HAW	2013-07-15
Z-1903-2013	Class I	Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage...	Nova Biomedical Corporation	NBW	2013-07-15
Z-1902-2013	Class I	Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product...	Nova Biomedical Corporation	NBW	2013-07-15
Z-1901-2013	Class I	Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are...	Nova Biomedical Corporation	NBW	2013-07-15
Z-1900-2013	Class I	Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product...	Nova Biomedical Corporation	NBW	2013-07-15
Z-1899-2013	Class I	Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The...	Nova Biomedical Corporation	NBW	2013-07-15
Z-1898-2013	Class I	Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The...	Nova Biomedical Corporation	NBW	2013-07-15
Z-1897-2013	Class I	Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage...	Nova Biomedical Corporation	NBW	2013-07-15
Z-2194-2013	Class II	Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm...	Ormco/Sybronendo	OAT	2013-07-12
Z-2096-2013	Class III	OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2...	Celera Corporation	LDT	2013-07-12
Z-2317-2013	Class II	Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental...	Atrium Medical Corporation	DSY	2013-07-12
Z-2316-2013	Class II	Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental...	Atrium Medical Corporation	DSY	2013-07-12
Z-2315-2013	Class II	Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction...	Atrium Medical Corporation	DSY	2013-07-12
Z-2314-2013	Class II	Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in...	Atrium Medical Corporation	DSY	2013-07-12
Z-2313-2013	Class II	Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental...	Atrium Medical Corporation	DYF	2013-07-12
Z-2312-2013	Class II	Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction...	Atrium Medical Corporation	DYF	2013-07-12
Z-0974-2014	Class II	5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties...	Custom Medical Specialties, Inc.	KKX	2013-07-12
Z-2311-2013	Class II	Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction...	Atrium Medical Corporation	DSY	2013-07-12
Z-2310-2013	Class II	Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental...	Atrium Medical Corporation	DSY	2013-07-12
Z-2309-2013	Class II	Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental...	Atrium Medical Corporation	DYF	2013-07-12
Z-2308-2013	Class II	Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular...	Atrium Medical Corporation	DSY	2013-07-12
Z-2307-2013	Class II	Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction...	Atrium Medical Corporation	DSY	2013-07-12
Z-2306-2013	Class II	Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction...	Atrium Medical Corporation	DSY	2013-07-12
Z-2305-2013	Class II	Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular...	Atrium Medical Corporation	DSY	2013-07-12
Z-2304-2013	Class II	Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular...	Atrium Medical Corporation	DSY	2013-07-12
Z-1946-2013	Class II	IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.	Stryker Medical	IOQ	2013-07-12
Z-2422-2018	Class II	AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24...	Cayenne Medical Inc.	HWC	2013-07-11
Z-1820-2013	Class I	LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of...	Depuy Orthopaedics Inc.	JWH	2013-07-11
Z-0646-2014	Class II	Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x...	Abbott Medical	MEG	2013-07-10
Z-0645-2014	Class II	Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2...	Abbott Medical	MEG	2013-07-10
Z-0644-2014	Class II	Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2...	Abbott Medical	MEG	2013-07-10
Z-0643-2014	Class II	Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2...	Abbott Medical	MEG	2013-07-10
Z-0642-2014	Class II	Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2...	Abbott Medical	MEG	2013-07-10
Z-2192-2013	Class II	BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx...	Becton Dickinson & Co	FMK	2013-07-10
Z-2162-2013	Class II	Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical...	Medical Indicators, Inc.	FQZ	2013-07-10
Z-0052-2014	Class II	Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg...	Siemens Medical Solutions USA, Inc.	IYN	2013-07-10
Z-1872-2013	Class II	Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part...	Precision Dynamics Corporation	FZZ	2013-07-10