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 2026-10-12, the FDA export date. FDA medical device recall database

59,476 records, page 279 of 1190

FDA device recalls, page 279 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2602-2021	Class II	DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference...	Siemens Healthcare Diagnostics Inc.	JJE	2021-07-21
Z-2386-2021	Class II	Stealth 360 Gen2 Peripheral Orbital Atherectomy System, 1.25Mm Micro, 145 Cm, Ref...	Cardiovascular Systems Incorporated	MCW	2021-07-21
Z-2385-2021	Class II	Diamondback 360 Gen2 Peripheral Orbital Atherectomy System, 1.5Mm Solid, 145 Cm, Ref...	Cardiovascular Systems Incorporated	MCW	2021-07-21
Z-2432-2021	Class I	Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C	Cordis US Corp.	DQO	2021-07-21
Z-2431-2021	Class I	Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B	Cordis US Corp.	DQO	2021-07-21
Z-2430-2021	Class I	Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A	Cordis US Corp.	DQO	2021-07-21
Z-2429-2021	Class I	Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB	Cordis US Corp.	DQO	2021-07-21
Z-2428-2021	Class I	Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF...	Cordis US Corp.	DQO	2021-07-21
Z-2243-2021	Class II	MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm...	Merit Medical Systems, Inc.	DYB	2021-07-21
Z-0153-2023	Class II	CritiCool, thermoregulation device	Belmont Medical Technologies	DWJ	2021-07-20
Z-2482-2021	Class II	Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of...	Welch Allyn Inc	FLL	2021-07-20
Z-2439-2021	Class II	Solero Generator PG, Item No. H78712740000, Catalog No. 12740000	Boston Scientific Corporation	NEY	2021-07-20
Z-2438-2021	Class II	Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D	Boston Scientific Corporation	NEY	2021-07-20
Z-2437-2021	Class II	Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US	Boston Scientific Corporation	NEY	2021-07-20
Z-2436-2021	Class II	Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD	Boston Scientific Corporation	NEY	2021-07-20
Z-2435-2021	Class II	Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The...	Nihon Kohden Orangemed, LLC	CBK	2021-07-20
Z-2356-2021	Class II	HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when...	Ethicon Endo-Surgery Inc	LFL	2021-07-20
Z-2355-2021	Class II	HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when...	Ethicon Endo-Surgery Inc	LFL	2021-07-20
Z-2245-2021	Class II	FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID...	BioFire Diagnostics, LLC	PEN	2021-07-20
Z-2235-2021	Class II	Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X	Cordis US Corp.	LIT	2021-07-19
Z-2427-2021	Class II	Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55...	Philips North America LLC	MKJ	2021-07-16
Z-2322-2021	Class II	RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF...	Teleflex Medical	BTR	2021-07-16
Z-2321-2021	Class II	RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF...	Teleflex Medical	BTR	2021-07-16
Z-2320-2021	Class II	RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a)...	Teleflex Medical	BTR	2021-07-16
Z-2319-2021	Class II	RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a)...	Teleflex Medical	BTR	2021-07-16
Z-0715-2024	Class II	(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number...	Philips North America LLC	LNI	2021-07-15
Z-0163-2022	Class III	Pneupac paraPac plus 300 ventilator kit, REF P300NGB	Abbott Medical	BTL	2021-07-15
Z-2332-2021	Class II	Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a...	Siemens Healthcare Diagnostics Inc.	JQP	2021-07-15
Z-2311-2021	Class III	Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16	Cell Marque Corp.	NJT	2021-07-15
Z-2449-2021	Class II	Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i...	PENTAX of America, Inc.	FDF	2021-07-14
Z-2448-2021	Class II	Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel...	PENTAX of America, Inc.	FDF	2021-07-14
Z-2242-2021	Class II	smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during...	Smith & Nephew Orthopaedics Ltd. (Aurora)	NXT	2021-07-14
Z-2309-2021	Class II	FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA	Verge Medical Inc.	LIT	2021-07-14
Z-2140-2021	Class II	Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for...	Maquet Cardiovascular Us Sales, LLC	DWC	2021-07-14
Z-2403-2021	Class I	EV3 Pipeline Flex Embolization Device with Flex Shield Technology	Medtronic, Inc.	OUT	2021-07-13
Z-2402-2021	Class I	Pipeline Flex Embolization Device	Medtronic, Inc.	OUT	2021-07-13
Z-2471-2021	Class II	ACUSON Juniper Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	2021-07-12
Z-2340-2021	Class II	Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm...	W. L. Gore & Associates, Inc.	MJN	2021-07-12
Z-2276-2021	Class II	Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro...	Abbott Medical	MZA	2021-07-12
Z-2203-2021	Class III	Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro...	Stanbio Laboratory	JIN	2021-07-12
Z-2202-2021	Class III	Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.	Stanbio Laboratory	JIN	2021-07-12
Z-2201-2021	Class III	Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.	Stanbio Laboratory	JIN	2021-07-12
Z-2200-2021	Class III	Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.	Stanbio Laboratory	JIN	2021-07-12
Z-2199-2021	Class III	Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.	Stanbio Laboratory	JIN	2021-07-12
Z-2440-2021	Class II	COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following...	Copan Italia	KXG	2021-07-09
Z-2330-2021	Class II	AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic...	PROCEPT BioRobotics Corporation	PZP	2021-07-09
Z-2325-2021	Class II	EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s)...	Precision Medical Products	JOW	2021-07-09
Z-2324-2021	Class II	CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF...	Precision Medical Products	JOW	2021-07-09
Z-2283-2021	Class II	Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable...	Edwards Lifesciences LLC	DQE	2021-07-09
Z-2282-2021	Class II	Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable...	Edwards Lifesciences LLC	DQE	2021-07-09