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 297 of 1190

FDA device recalls, page 297 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1578-2021	Class II	REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip...	Abbott Medical	ONB	2021-03-16
Z-1577-2021	Class II	REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for...	Abbott Medical	ONB	2021-03-16
Z-1576-2021	Class II	REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for...	Abbott Medical	ONB	2021-03-16
Z-1575-2021	Class II	REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon...	Abbott Medical	ONB	2021-03-16
Z-1574-2021	Class II	REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port...	Abbott Medical	ONB	2021-03-16
Z-1573-2021	Class II	REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap...	Abbott Medical	ONB	2021-03-16
Z-1572-2021	Class II	REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap...	Abbott Medical	ONB	2021-03-16
Z-1571-2021	Class II	REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip...	Abbott Medical	ONB	2021-03-16
Z-1570-2021	Class II	REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip...	Abbott Medical	ONB	2021-03-16
Z-1569-2021	Class II	REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the...	Abbott Medical	FPA	2021-03-16
Z-1568-2021	Class II	REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access...	Abbott Medical	FPA	2021-03-16
Z-1567-2021	Class II	REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber...	Abbott Medical	FPA	2021-03-16
Z-1566-2021	Class II	REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197...	Abbott Medical	FPA	2021-03-16
Z-1565-2021	Class II	REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610...	Abbott Medical	FPA	2021-03-16
Z-1532-2021	Class II	Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090...	Medtronic, Inc.	QAN	2021-03-16
Z-1492-2021	Class III	EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for...	Boston Scientific Corporation	FDT	2021-03-16
Z-1410-2021	Class II	Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing...	K2M, Inc	HRS	2021-03-16
Z-1408-2021	Class II	VIDAS CMV IgM 30 Tests	bioMerieux, Inc.	LKQ	2021-03-16
Z-1772-2021	Class II	MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN; PUMP MMT-1740KX...	Medtronic, Inc.	OZP	2021-03-15
Z-1771-2021	Class II	MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886...	Medtronic, Inc.	OZP	2021-03-15
Z-1509-2021	Class II	Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog...	B Braun Medical Inc	FPA	2021-03-15
Z-1407-2021	Class II	Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site...	MEDLINE INDUSTRIES, LP - Northfield	JIN	2021-03-15
Z-1531-2021	Class I	ENDURITY Pulse Generator REF PM** SN ******* St. Jude Medical Cardiac Rhythm...	Abbott Medical	NVZ	2021-03-15
Z-1530-2021	Class I	ASSURITY Pulse Generator REF PM** SN ******* ST. JUDE MEDICAL Assurity and...	Abbott Medical	NVZ	2021-03-15
Z-1992-2021	Class II	HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)	Mallinckrodt, Inc.	MQB	2021-03-11
Z-1423-2021	Class II	Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD...	Krishe Inc	QBD	2021-03-11
Z-1422-2021	Class II	Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal...	Krishe Inc	JSM	2021-03-11
Z-1421-2021	Class II	Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab...	Krishe Inc	QBD	2021-03-11
Z-1420-2021	Class II	Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50...	Krishe Inc	JSM	2021-03-11
Z-1380-2021	Class II	Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment...	Arthrex GmbH	HRS	2021-03-11
Z-1437-2021	Class II	Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar...	Howmedica Osteonics Corp	MAX	2021-03-11
Z-1346-2021	Class II	Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate...	Siemens Medical Solutions USA, Inc.	KPR	2021-03-10
Z-1329-2021	Class II	AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for...	Oscor Inc.	DYB	2021-03-10
Z-1425-2021	Class II	Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium...	Remel Inc	JSO	2021-03-10
Z-1424-2021	Class II	Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium...	Remel Inc	JSO	2021-03-10
Z-1368-2021	Class II	A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming...	Medtronic Neuromodulation	MHY	2021-03-09
Z-1465-2021	Class II	BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product...	BIOTRONIK AG	LWS	2021-03-08
Z-1464-2021	Class II	BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage...	BIOTRONIK AG	LWS	2021-03-08
Z-1463-2021	Class II	BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product...	BIOTRONIK AG	LWS	2021-03-08
Z-1462-2021	Class II	BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage...	BIOTRONIK AG	LWS	2021-03-08
Z-1461-2021	Class II	BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1460-2021	Class II	BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1459-2021	Class II	BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product...	BIOTRONIK AG	MRM	2021-03-08
Z-1458-2021	Class II	BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1457-2021	Class II	BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1456-2021	Class II	BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1455-2021	Class II	BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1454-2021	Class II	BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1453-2021	Class II	BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1452-2021	Class II	BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended...	BIOTRONIK AG	MRM	2021-03-08