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 298 of 1190

FDA device recalls, page 298 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
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
Z-1451-2021	Class II	BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended...	BIOTRONIK AG	MRM	2021-03-08
Z-1450-2021	Class II	BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1449-2021	Class II	BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product...	BIOTRONIK AG	MRM	2021-03-08
Z-1448-2021	Class II	BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended...	BIOTRONIK AG	MRM	2021-03-08
Z-1447-2021	Class II	BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1446-2021	Class II	BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1445-2021	Class II	BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage...	BIOTRONIK AG	MRM	2021-03-08
Z-1444-2021	Class II	BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended...	BIOTRONIK AG	MRM	2021-03-08
Z-1443-2021	Class II	BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended...	BIOTRONIK AG	MRM	2021-03-08
Z-1442-2021	Class II	BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended...	BIOTRONIK AG	MRM	2021-03-08
Z-1441-2021	Class II	BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended...	BIOTRONIK AG	MRM	2021-03-08
Z-1374-2021	Class II	Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy...	Arrow International LLC (subsidiary of Teleflex Incorporated)	KNW	2021-03-08
Z-1411-2021	Class II	Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting &...	Medtronic, Inc.	GEI	2021-03-05
Z-1430-2021	Class II	MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek...	Boston Scientific Corporation	DQY	2021-03-05
Z-1429-2021	Class II	MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a...	Boston Scientific Corporation	DQY	2021-03-05
Z-1406-2021	Class II	Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally...	Centinel Spine, LLC	MJO	2021-03-05
Z-1379-2021	Class II	Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK...	Howmedica Osteonics Corp	JWH	2021-03-05
Z-1405-2021	Class II	ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1404-2021	Class II	ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1403-2021	Class II	ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1402-2021	Class II	ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1401-2021	Class II	ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1400-2021	Class II	ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1399-2021	Class II	ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1398-2021	Class II	ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1397-2021	Class II	ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1396-2021	Class II	ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1395-2021	Class II	ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1394-2021	Class II	ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1393-2021	Class II	ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1392-2021	Class II	ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1391-2021	Class II	ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1390-2021	Class II	ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1389-2021	Class II	ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1388-2021	Class II	ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1387-2021	Class II	ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-1386-2021	Class II	ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology...	Siemens Healthcare Diagnostics Inc.	GKZ	2021-03-05
Z-2479-2021	Class II	Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring...	Arjohuntleigh Magog, Inc.	FSA	2021-03-04
Z-1434-2021	Class II	Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server...	Siemens Medical Solutions USA, Inc.	DQK	2021-03-04
Z-1385-2021	Class II	Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm...	Medtronic, Inc.	CDW	2021-03-04