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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 426 of 1190

FDA device recalls, page 426 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0567-2019	Class II	SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile...	CIVCO Medical Instruments Co., Inc.	ITX	2018-11-02
Z-0566-2019	Class II	SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile...	CIVCO Medical Instruments Co., Inc.	ITX	2018-11-02
Z-0565-2019	Class II	CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use...	CIVCO Medical Instruments Co., Inc.	ITX	2018-11-02
Z-0564-2019	Class II	CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with...	CIVCO Medical Instruments Co., Inc.	ITX	2018-11-02
Z-0563-2019	Class II	SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers...	CIVCO Medical Instruments Co., Inc.	ITX	2018-11-02
Z-0460-2019	Class II	RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product...	Virtual Imaging, Inc.	MQB	2018-11-02
Z-0562-2019	Class II	CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable...	CIVCO Medical Instruments Co., Inc.	ITX	2018-11-02
Z-0220-2020	Class II	SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The...	LivaNova USA, Inc.	DWC	2018-11-01
Z-0689-2019	Class II	VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use...	Ortho-Clinical Diagnostics, Inc.	NBC	2018-11-01
Z-0688-2019	Class II	VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative...	Ortho-Clinical Diagnostics, Inc.	LOM	2018-11-01
Z-0687-2019	Class II	VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro...	Ortho-Clinical Diagnostics, Inc.	LOM	2018-11-01
Z-0691-2019	Class III	Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM...	R & D Systems, Inc.	JNM	2018-11-01
Z-0624-2019	Class II	Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high...	Trinity Biotech USA	GKA	2018-11-01
Z-0623-2019	Class II	Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance...	Trinity Biotech USA	GKA	2018-11-01
Z-0622-2019	Class II	Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance...	Trinity Biotech USA	GKA	2018-11-01
Z-0621-2019	Class II	Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high...	Trinity Biotech USA	GKA	2018-11-01
Z-0620-2019	Class II	ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high...	Trinity Biotech USA	GKA	2018-11-01
Z-0474-2019	Class II	The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter...	Boston Scientific Corporation	LWS	2018-11-01
Z-0638-2019	Class II	Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored...	Medtronic, Inc.	KGO	2018-10-31
Z-0637-2019	Class II	Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored...	Medtronic, Inc.	KGO	2018-10-31
Z-0636-2019	Class II	Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored...	Medtronic, Inc.	KGO	2018-10-31
Z-0635-2019	Class II	Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored...	Medtronic, Inc.	KGO	2018-10-31
Z-0634-2019	Class II	Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored...	Medtronic, Inc.	KGO	2018-10-31
Z-0633-2019	Class II	Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile...	Medtronic, Inc.	KGO	2018-10-31
Z-0632-2019	Class II	Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored...	Medtronic, Inc.	KGO	2018-10-31
Z-0649-2019	Class II	FoundationOne CDx Test Results	Foundation Medicine, Inc.	PQP	2018-10-31
Z-0644-2019	Class II	Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001...	Zimmer GmbH	LZO	2018-10-31
Z-0630-2019	Class II	NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with...	Zimmer GmbH	JWH	2018-10-31
Z-0631-2019	Class II	Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored...	Medtronic, Inc.	KGO	2018-10-31
Z-0597-2019	Class II	Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code...	Medtronic, Inc.	KNT	2018-10-31
Z-0119-2020	Class II	Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631...	Horiba Instruments Incorporated	CHI	2018-10-30
Z-0752-2019	Class III	Porcine Anorganic Bone Mineral 4.0cc	Collagen Matrix, Inc	NPM	2018-10-30
Z-0363-2020	Class II	Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x...	Implant Direct Sybron Manufacturing LLC	DZE	2018-10-26
Z-0027-2020	Class II	Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only...	Merit Medical Systems, Inc.	OES	2018-10-26
Z-0026-2020	Class II	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only...	Merit Medical Systems, Inc.	OEQ	2018-10-26
Z-0558-2019	Class II	Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated...	Siemens Medical Solutions USA, Inc.	IZI	2018-10-26
Z-1906-2020	Class II	da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch	Intuitive Surgical, Inc.	NAY	2018-10-25
Z-0836-2019	Class II	HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)	Magstim Inc.	OBP	2018-10-25
Z-0437-2019	Class I	QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO...	Maquet Cardiovascular Us Sales, LLC	DTZ	2018-10-25
Z-0436-2019	Class I	QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO...	Maquet Cardiovascular Us Sales, LLC	DTZ	2018-10-25
Z-0553-2019	Class II	Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion...	Zimmer GmbH	JDI	2018-10-24
Z-0526-2019	Class III	NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect...	Halyard Health	KNT	2018-10-24
Z-0845-2020	Class II	The da Vinci SP surgical system is made of three main components: the Surgeon Console...	Intuitive Surgical, Inc.	NAY	2018-10-23
Z-1281-2019	Class II	NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT...	Neusoft Medical Systems Co., Ltd.	JAK	2018-10-22
Z-1280-2019	Class II	NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner...	Neusoft Medical Systems Co., Ltd.	JAK	2018-10-22
Z-1279-2019	Class II	NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System...	Neusoft Medical Systems Co., Ltd.	JAK	2018-10-22
Z-0528-2019	Class II	BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective...	Becton Dickinson & Co	JSG	2018-10-22
Z-0589-2019	Class II	ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive...	ArjoHuntleigh Polska Sp. zo.o.	FSA	2018-10-22
Z-0508-2019	Class II	PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a...	Novanta Medical GmbH	HIF	2018-10-22
Z-0496-2019	Class II	Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108	Zimmer GmbH	JWH	2018-10-22