510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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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

59,476 records, page 209 of 1190
FDA device recalls, page 209 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1464-2023Class IIVersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STSMedtronic, Inc.GCJ
Z-1463-2023Class IIVersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STSMedtronic, Inc.GCJ
Z-1438-2023Class IISterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A...ROi CPS LLCOJH
Z-1437-2023Class IISterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH...ROi CPS LLCOJG
Z-1436-2023Class IISterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section...ROi CPS LLCOHM
Z-1435-2023Class IISterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN...ROi CPS LLCOHD
Z-1434-2023Class IISterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac...ROi CPS LLCOES
Z-1433-2023Class IISterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major...ROi CPS LLCMLS
Z-1432-2023Class IISterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I...ROi CPS LLCLRO
Z-1431-2023Class IISterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General...ROi CPS LLCFDE
Z-1415-2023Class IIBD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as...Becton Dickinson & CoJTC
Z-1566-2023Class IReplacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems...Abbott MedicalFRN
Z-1565-2023Class IReplacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List...Abbott MedicalFRN
Z-1647-2023Class IIPhilips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and...Philips Medical Systems Nederland B.V.OWB
Z-1469-2023Class IIARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and...Siemens Medical Solutions USA, Inc.OWB
Z-1554-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number...LinkBio Corp.KRO
Z-1553-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number...LinkBio Corp.KRO
Z-1552-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number...LinkBio Corp.KRO
Z-1551-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number...LinkBio Corp.KRO
Z-1550-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number...LinkBio Corp.KRO
Z-1549-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number...LinkBio Corp.KRO
Z-1548-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number...LinkBio Corp.KRO
Z-1547-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number...LinkBio Corp.KRO
Z-1546-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number...LinkBio Corp.KRO
Z-1545-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number...LinkBio Corp.KRO
Z-1544-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number...LinkBio Corp.KRO
Z-1543-2023Class IILINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number...LinkBio Corp.KRO
Z-1542-2023Class IILINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60LinkBio Corp.KRO
Z-1541-2023Class IILINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52LinkBio Corp.KRO
Z-1540-2023Class IILINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number...LinkBio Corp.KRO
Z-1539-2023Class IILINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40LinkBio Corp.KRO
Z-1538-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15LinkBio Corp.HSX
Z-1537-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14LinkBio Corp.HSX
Z-1536-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13LinkBio Corp.HSX
Z-1535-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12LinkBio Corp.HSX
Z-1534-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11LinkBio Corp.HSX
Z-1533-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10LinkBio Corp.HSX
Z-1532-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08LinkBio Corp.HSX
Z-1531-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07LinkBio Corp.HSX
Z-1530-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06LinkBio Corp.HSX
Z-1529-2023Class IILINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04LinkBio Corp.HSX
Z-1528-2023Class IILINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03LinkBio Corp.HSX
Z-1527-2023Class IILINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02LinkBio Corp.HSX
Z-1526-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16LinkBio Corp.HSX
Z-1525-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15LinkBio Corp.HSX
Z-1524-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14LinkBio Corp.HSX
Z-1523-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13LinkBio Corp.HSX
Z-1522-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12LinkBio Corp.HSX
Z-1521-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11LinkBio Corp.HSX
Z-1520-2023Class IILINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10LinkBio Corp.HSX