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 695 of 1191

FDA device recalls, page 695 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2567-2014	Class II	C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac...	Varian Medical Systems, Inc.	IYE	2014-06-17
Z-2025-2014	Class II	SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A...	CareFusion 303, Inc	FPA	2014-06-17
Z-2074-2014	Class II	Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For...	Baxter Healthcare Corporation	KDI	2014-06-17
Z-2019-2014	Class II	Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)	Terumo Cardiovascular Systems Corporation	DTQ	2014-06-17
Z-2018-2014	Class II	Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)	Terumo Cardiovascular Systems Corporation	DTQ	2014-06-17
Z-2173-2014	Class II	Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D	Medtronic, Inc.	FRN	2014-06-16
Z-1980-2014	Class II	Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in...	Nidek Incorporated	HKI	2014-06-16
Z-2263-2015	Class II	Paragon Laboratory Management	Mckesson Technologies, Inc.	JQP	2014-06-15
Z-2078-2014	Class II	Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to...	Dentalez, Inc., Stardental Division	EFA	2014-06-13
Z-2024-2014	Class II	Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide...	Aesculap Inc	GAR	2014-06-13
Z-1865-2014	Class II	Ingenia 1.5T, magnetic resonance imaging system.	Philips North America LLC	LNH	2014-06-13
Z-1864-2014	Class II	Ingenia 3.0T, magnetic resonance imaging system.	Philips North America LLC	LNH	2014-06-13
Z-1863-2014	Class II	Ingenia 1.5T R5, magnetic resonance imaging system.	Philips North America LLC	LNH	2014-06-13
Z-1862-2014	Class II	Ingenia 3.0T R5, magnetic resonance imaging system.	Philips North America LLC	LNH	2014-06-13
Z-2085-2014	Class II	GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.	GE Healthcare	MHX	2014-06-13
Z-2020-2014	Class II	Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci...	Intuitive Surgical, Inc.	NAY	2014-06-13
Z-2263-2014	Class II	WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No...	Biolase MG LLC	GEX	2014-06-12
Z-2115-2014	Class II	Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device...	HeartSine Technologies Ltd	MKJ	2014-06-12
Z-2116-2014	Class II	EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK...	PENTAX of America, Inc.	FDS	2014-06-12
Z-1957-2014	Class II	Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action...	Medical Action Industries, Inc. 306	OVN	2014-06-12
Z-1956-2014	Class II	McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex...	Medical Action Industries, Inc. 306	OVN	2014-06-12
Z-1955-2014	Class II	Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action...	Medical Action Industries, Inc. 306	OVN	2014-06-12
Z-1954-2014	Class II	Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc...	Medical Action Industries, Inc. 306	OVN	2014-06-12
Z-1953-2014	Class II	Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex...	Medical Action Industries, Inc. 306	OVN	2014-06-12
Z-1952-2014	Class II	Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case...	Medical Action Industries, Inc. 306	OVN	2014-06-12
Z-1951-2014	Class II	Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action...	Medical Action Industries, Inc. 306	MCZ	2014-06-12
Z-1950-2014	Class II	Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries...	Medical Action Industries, Inc. 306	OVN	2014-06-12
Z-2032-2014	Class II	Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX...	Zimmer Manufacturing B.V.	HWC	2014-06-12
Z-1696-2017	Class II	Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by...	Hitachi Aloka Medical, Ltd.	IYN	2014-06-11
Z-1050-2015	Class II	Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part...	Abbott Medical	FRN	2014-06-11
Z-2076-2014	Class II	Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer...	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	JDQ	2014-06-11
Z-2118-2014	Class II	Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in...	Medtronic Neuromodulation	HAW	2014-06-11
Z-2057-2014	Class II	Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50...	Remel Inc	MDB	2014-06-11
Z-1871-2014	Class II	IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical...	Intuitive Surgical, Inc.	NAY	2014-06-11
Z-1870-2014	Class II	IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical...	Intuitive Surgical, Inc.	NAY	2014-06-11
Z-1976-2014	Class II	Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight...	Integra LifeSciences Corporation	HPP	2014-06-11
Z-2068-2014	Class I	DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA...	GE Healthcare	CCK	2014-06-11
Z-0136-2015	Class II	Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous...	Animas Corp.	N/A	2014-06-10
Z-2131-2014	Class II	Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st...	Zimmer GmbH	HRS	2014-06-10
Z-1963-2014	Class II	EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200...	Baxter Healthcare Corporation	LHI	2014-06-10
Z-2652-2014	Class II	Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting...	ArjoHuntleigh Polska Sp. zo.o.	FSA	2014-06-10
Z-0475-2016	Class II	Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange...	Arthrosurface, Inc.	LZJ	2014-06-09
Z-2132-2014	Class II	MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by...	Nidek Incorporated	HQF	2014-06-09
Z-2058-2014	Class II	Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens...	Siemens Healthcare Diagnostics Inc.	CIZ	2014-06-09
Z-1924-2014	Class I	Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar...	Medtronic Neurosurgery	JXG	2014-06-09
Z-1923-2014	Class I	Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites...	Medtronic Neurosurgery	JXG	2014-06-09
Z-1922-2014	Class I	Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites...	Medtronic Neurosurgery	JXG	2014-06-09
Z-1921-2014	Class I	Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites...	Medtronic Neurosurgery	JXG	2014-06-09
Z-1920-2014	Class I	Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites...	Medtronic Neurosurgery	JXG	2014-06-09
Z-1961-2014	Class II	MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm)...	Integra LifeSciences Corporation	NKB	2014-06-09