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 299 of 1190

FDA device recalls, page 299 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1384-2021	Class II	Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm...	Medtronic, Inc.	CDW	2021-03-04
Z-1383-2021	Class II	Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm...	Medtronic, Inc.	GDW	2021-03-04
Z-1376-2021	Class II	Regard, Item Number 830067009, custom cardiovascular procedure kit	ROi CPS LLC	OEZ	2021-03-04
Z-1693-2023	Class II	p-Chip Wand Reader	p-Chip Corporation	RFN	2021-03-03
Z-1313-2021	Class I	Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC...	Medtronic Perfusion Systems	DWA	2021-03-03
Z-1281-2021	Class II	RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that...	RaySearch Laboratories AB (publ)	MUJ	2021-03-03
Z-1253-2021	Class II	Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography...	Siemens Medical Solutions USA, Inc.	JAK	2021-03-03
Z-1309-2021	Class I	BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door...	CareFusion 303, Inc	FRN	2021-03-03
Z-1435-2021	Class II	BCS XP System: Multipurpose system for in vitro coagulation studies. Product code...	Siemens Healthcare Diagnostics Inc.	JPA	2021-03-02
Z-1348-2021	Class II	Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as...	FUJIFILM Healthcare Americas Corporation	LLZ	2021-03-02
Z-1432-2021	Class II	Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid...	Azure Biotech Inc	QKO	2021-03-02
Z-1367-2021	Class II	Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or...	Terumo Cardiovascular Systems Corporation	MWS	2021-03-02
Z-1175-2024	Class II	Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US...	Abiomed, Inc.	OZD	2021-03-01
Z-2452-2021	Class II	Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to...	Cellex	QKP	2021-03-01
Z-1687-2021	Class II	MyWay Walker Chassis - Product Usage: is intended for use by children already using a...	James Leckey Design Ltd	ITJ	2021-03-01
Z-1282-2021	Class II	Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained...	FUJIFILM Healthcare Americas Corporation	IYN	2021-03-01
Z-1185-2021	Class II	ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).	Brainlab, Inc.	IYE	2021-03-01
Z-1543-2021	Class I	Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted...	Step-Har Medical LLC	FRN	2021-02-26
Z-1618-2021	Class II	Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS...	Medtronic, Inc.	MDS	2021-02-26
Z-1617-2021	Class II	Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS...	Medtronic, Inc.	MDS	2021-02-26
Z-1616-2021	Class II	Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L...	Medtronic, Inc.	MDS	2021-02-26
Z-1615-2021	Class II	Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L...	Medtronic, Inc.	MDS	2021-02-26
Z-1614-2021	Class II	Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK...	Medtronic, Inc.	MDS	2021-02-26
Z-1613-2021	Class II	Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L...	Medtronic, Inc.	MDS	2021-02-26
Z-1612-2021	Class II	Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK...	Medtronic, Inc.	MDS	2021-02-26
Z-1611-2021	Class II	Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L...	Medtronic, Inc.	MDS	2021-02-26
Z-1610-2021	Class II	Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L...	Medtronic, Inc.	MDS	2021-02-26
Z-1609-2021	Class II	Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK...	Medtronic, Inc.	MDS	2021-02-26
Z-1608-2021	Class II	Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L...	Medtronic, Inc.	MDS	2021-02-26
Z-1607-2021	Class II	Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK...	Medtronic, Inc.	MDS	2021-02-26
Z-1606-2021	Class II	Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI...	Medtronic, Inc.	MDS	2021-02-26
Z-1605-2021	Class II	Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/...	Medtronic, Inc.	MDS	2021-02-26
Z-1604-2021	Class II	Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/...	Medtronic, Inc.	MDS	2021-02-26
Z-1603-2021	Class II	Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US...	Medtronic, Inc.	MDS	2021-02-26
Z-1602-2021	Class II	Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L...	Medtronic, Inc.	MDS	2021-02-26
Z-1601-2021	Class II	Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L...	Medtronic, Inc.	MDS	2021-02-26
Z-1438-2021	Class II	Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these...	HeartWare, Inc.	DSQ	2021-02-26
Z-1469-2021	Class II	Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these...	HeartWare, Inc.	DSQ	2021-02-26
Z-1369-2021	Class II	Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product...	Hologic, Inc.	NSU	2021-02-26
Z-1428-2021	Class II	Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical...	Stryker Corp.	GCJ	2021-02-26
Z-1287-2021	Class II	Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF...	Biosense Webster Inc	DYB	2021-02-26
Z-1286-2021	Class II	Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF...	Biosense Webster Inc	DYB	2021-02-26
Z-1288-2021	Class II	Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and...	Siemens Medical Solutions USA, Inc.	OWB	2021-02-26
Z-1600-2021	Class II	Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE...	Medtronic, Inc.	MDS	2021-02-26
Z-1599-2021	Class II	Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS...	Medtronic, Inc.	MDS	2021-02-26
Z-1341-2021	Class I	Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR...	HeartWare, Inc.	DSQ	2021-02-26
Z-1426-2021	Class I	Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these...	HeartWare, Inc.	DSQ	2021-02-26
Z-1340-2021	Class I	Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE	HeartWare, Inc.	DSQ	2021-02-26
Z-1339-2021	Class I	Medtronic HVAD Monitor Data Cable, Product Number: 1575	HeartWare, Inc.	DSQ	2021-02-26
Z-1338-2021	Class I	Medtronic HVAD Alarm Adapter, Product Number: 1450	HeartWare, Inc.	DSQ	2021-02-26