510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 , the FDA export date. FDA medical device recall database

59,460 records, page 1108 of 1190
FDA device recalls, page 1108 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1504-05Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/50/Plastic Catalog Number: 45-557Boston Scientific CorporationKOB
Z-1503-05Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/50/Metal Catalog Number: 45-556Boston Scientific CorporationKOB
Z-1502-05Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/37/Plastic Catalog Number: 45-555Boston Scientific CorporationKOB
Z-1501-05Vaxcel Plus Chronic Dialysis Catheters -Kit/CPU/15/37/Metal Catalog Number: 45-554Boston Scientific CorporationKOB
Z-1500-05Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/37/Plastic Catalog Number...Boston Scientific CorporationKOB
Z-1499-05Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/37/Metal Catalog Number : 45-552Boston Scientific CorporationKOB
Z-1498-05Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/28/Plastic Catalog Number : 45-551Boston Scientific CorporationKOB
Z-1497-05Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/28/Metal Catalog Number : 45-550Boston Scientific CorporationKOB
Z-1496-05Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/28/Plastic Catalog Number...Boston Scientific CorporationKOB
Z-1495-05Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/28/Metal Catalog Number : 45-548Boston Scientific CorporationKOB
Z-1494-05Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/23/Plastic Catalog Number : 45-547Boston Scientific CorporationKOB
Z-1493-05Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/23/Metal Catalog Number : 45-546Boston Scientific CorporationKOB
Z-1492-05Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/23/Plastic Catalog Number...Boston Scientific CorporationKOB
Z-1491-05Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/23/Metal Catalog Number : 45-544Boston Scientific CorporationKOB
Z-1490-05Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/19/Plastic Catalog Number : 45-543Boston Scientific CorporationKOB
Z-1489-05Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/19/Metal Catalog Number : 45-542Boston Scientific CorporationKOB
Z-1488-05Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Plastic Catalog Number...Boston Scientific CorporationKOB
Z-1487-05Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Metal Catalog Number : 45-540Boston Scientific CorporationKOB
Z-1486-05Vaxcel Chronic Dialysis Catheter - Catheter/PU/14/23/Plastic Catalog Number : 45-520Boston Scientific CorporationKOB
Z-1485-05Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV...Boston Scientific CorporationKOB
Z-1484-05Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV...Boston Scientific CorporationKOB
Z-1483-05Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV...Boston Scientific CorporationKOB
Z-1482-05Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV...Boston Scientific CorporationKOB
Z-1481-05Vaxcel Chest Ports - Standard/PS/PU/9/1.8/2.8/63 Catalog Number : 45-360Boston Scientific CorporationKOB
Z-1480-05Vaxcel Chest Ports - Standard/PS/S/8/1.5/2.6/63 Catalog Number : 45-340Boston Scientific CorporationKOB
Z-1479-05Vaxcel Chest Ports - Standard/T/S/8/1.5/2.6/63 Catalog Number : 45-320Boston Scientific CorporationKOB
Z-1478-05Vaxcel Chest Ports - Standard/T/PU/9/1.8/2.8/63 Catalog Number : 45-315Boston Scientific CorporationKOB
Z-1477-05Vaxcel Chest Ports - Mini/T/S/8/1.5/2.6/63 Catalog Number : 45-310Boston Scientific CorporationKOB
Z-1476-05Vaxcel Chest Ports - Mini/T/PU/7/1.3/2.2/63 Catalog Number : 45-305Boston Scientific CorporationKOB
Z-1475-05Vaxcel Chest Ports - Mini/T/PU/6/1.1/1.9/63 Catalog Number : 45-303Boston Scientific CorporationKOB
Z-1474-05Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV...Boston Scientific CorporationKOB
Z-1473-05Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV...Boston Scientific CorporationKOB
Z-1472-05Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV...Boston Scientific CorporationKOB
Z-1471-05Banana Peel™ Sheaths BP/9/45 Catalog Number : 20-618Boston Scientific CorporationKOB
Z-1470-05Banana Peel™ Sheaths BP/16/30 Catalog Number : 20-616Boston Scientific CorporationKOB
Z-1469-05Banana Peel™ Sheaths BP/14/30 Catalog Number : 20-615Boston Scientific CorporationKOB
Z-1468-05Banana Peel™ Sheaths BP/12/30 Catalog Number : 20-614Boston Scientific CorporationKOB
Z-1467-05Banana Peel™ Sheaths BP/11/30 Catalog Number : 20-613Boston Scientific CorporationKOB
Z-1466-05Banana Peel™ Sheaths BP/9/30 Catalog Number : 20-612Boston Scientific CorporationKOB
Z-1465-05Banana Peel™ Sheaths BP/16/15 Catalog NUmber : 20-610Boston Scientific CorporationKOB
Z-1464-05Banana Peel™ Sheaths BP/14/15 Catalog Number: 20-609Boston Scientific CorporationKOB
Z-1463-05Banana Peel™ Sheaths BP/12/15 Catalog Number: 20-608Boston Scientific CorporationKOB
Z-1462-05Banana Peel™ Sheaths BP/11/15 Catalog Number: 20-607Boston Scientific CorporationKOB
Z-1461-05Banana Peel™ Sheaths BP/9/15 Catalog Number: 20-606Boston Scientific CorporationKOB
Z-1585-05Bard Luminexx 3 Biliary Stent and Delivery SystemBard Peripheral Vascular IncFGE
Z-0517-06Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer...GE HealthcareCCK
Z-1060-05Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation...Baxter Healthcare CorporationFRN
Z-1059-05Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation...Baxter Healthcare CorporationFRN
Z-1598-05Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator...Ela Medical, Inc.MRM
Z-1597-05Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator...Ela Medical, Inc.MRM