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

59,486 records, page 379 of 1190
FDA device recalls, page 379 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0067-2020Class IIBD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD...Becton, Dickinson and Company, BD BiosciencesOYE
Z-0066-2020Class IIBD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD...Becton, Dickinson and Company, BD BiosciencesOYE
Z-0612-2020Class IIREF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be...Enztec LimitedHWA
Z-0191-2020Class IIIrrisept Wound Debridement and Cleansing System. 12 units per case.IrriMAX CorporationFQH
Z-2795-2020Class IIBioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use...BiosealBZA
Z-1426-2020Class IITotal Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300...Siemens Healthcare Diagnostics Inc.CIG
Z-1425-2020Class IIDirect Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200...Siemens Healthcare Diagnostics Inc.CIG
Z-1424-2020Class IIUric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI...Siemens Healthcare Diagnostics Inc.KNK
Z-1423-2020Class IITriglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only...Siemens Healthcare Diagnostics Inc.CDT
Z-1422-2020Class IIEnzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx...Siemens Healthcare Diagnostics Inc.JFY
Z-0343-2020Class IIGrab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti...Western Enterprises, Inc.ECX
Z-0342-2020Class IIGrab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti...Western Enterprises, Inc.ECX
Z-0341-2020Class IIGrab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti...Western Enterprises, Inc.ECX
Z-0340-2020Class IIGrab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti...Western Enterprises, Inc.ECX
Z-0339-2020Class IIGrab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti...Western Enterprises, Inc.ECX
Z-1430-2020Class IIRemisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and...Normand-Info S.A.S.U.JQP
Z-0205-2020Class IIAtellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number...Siemens Healthcare Diagnostics Inc.JJE
Z-0204-2020Class IIAtellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number...Siemens Healthcare Diagnostics Inc.JJE
Z-2548-2019Class IIQuickGraft Model # 430PSTMusculoskeletal Transplant Foundation d/b/a/ MTF BiologicsGAT
Z-2537-2019Class IIVanguard XP Tibial Tray 87 mm Item # 195254Zimmer GmbHJWH
Z-2536-2019Class IIVanguard XP Tibial Tray 83 mm Item # 195253Zimmer GmbHJWH
Z-2535-2019Class IIVanguard XP Tibial Tray 79 mm Item # 195252Zimmer GmbHJWH
Z-2534-2019Class IIVanguard XP Tibial Tray 75 mm Item # 195251Zimmer GmbHJWH
Z-2533-2019Class IIVanguard XP Tibial Tray 73 mm Item # 195250Zimmer GmbHJWH
Z-2532-2019Class IIVanguard XP Tibial Tray 71 mm Item # 195249Zimmer GmbHJWH
Z-2531-2019Class IIVanguard XP Tibial Tray 69 mm Item # 195248Zimmer GmbHJWH
Z-2530-2019Class IIVanguard XP Tibial Tray 67 mm Item # 195247Zimmer GmbHJWH
Z-2529-2019Class IIVanguard XP Tibial Tray 65 mm Item # 195246Zimmer GmbHJWH
Z-2528-2019Class IIVanguard XP Tibial Tray 63 mm Item # 195245Zimmer GmbHJWH
Z-2527-2019Class IIXP-XP Tibial Tray - Interlok 59 mm Item # 195750Zimmer GmbHJWH
Z-2526-2019Class IIXP-XP Tibial Tray - Interlok 63 mm Item # 195751Zimmer GmbHJWH
Z-2525-2019Class IIXP-XP Tibial Tray - Interlok 65 mm Item # 195752Zimmer GmbHJWH
Z-2524-2019Class IIXP-XP Tibial Tray - Interlok 67 mm Item # 195753Zimmer GmbHJWH
Z-2523-2019Class IIXP-XP Tibial Tray - Interlok 69 mm Item # 195754Zimmer GmbHJWH
Z-2522-2019Class IIXP-XP Tibial Tray - Interlok 71 mm Item # 195755Zimmer GmbHJWH
Z-2521-2019Class IIXP-XP Tibial Tray - Interlok 73 mm Item # 195756Zimmer GmbHJWH
Z-2520-2019Class IIXP-XP Tibial Tray - Interlok 75 mm Item # 195757Zimmer GmbHJWH
Z-2519-2019Class IIXP-XP Tibial Tray - Interlok 79 mm Item # 195758Zimmer GmbHJWH
Z-2518-2019Class IIXP-XP Tibial Tray - Interlok 83 mm Item # 195759Zimmer GmbHJWH
Z-2517-2019Class IIXP-XP Tibial Tray - Interlok 87 mm Item # 195760Zimmer GmbHJWH
Z-2516-2019Class IIXP-XP Tibial Tray - Interlok 91mm Item # 195761Zimmer GmbHJWH
Z-2515-2019Class IIXP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291Zimmer GmbHJWH
Z-2514-2019Class IIXP-CR Tibial Tray - Interlok 91 mm Item # 195279Zimmer GmbHJWH
Z-2513-2019Class IIXP-CR Tibial Tray - Interlok 87 mm Item # 195278Zimmer GmbHJWH
Z-2512-2019Class IIXP-CR Tibial Tray - Interlok 83 mm Item # 195277Zimmer GmbHJWH
Z-2511-2019Class IIXP-CR Tibial Tray - Interlok 79 mm Item # 195276Zimmer GmbHJWH
Z-2510-2019Class IIXP-CR Tibial Tray - Interlok 75mm Item # 195275Zimmer GmbHJWH
Z-2509-2019Class IIXP-CR Tibial Tray - Interlok 73mm Item # 195274Zimmer GmbHJWH
Z-2508-2019Class IIXP-CR Tibial Tray - Interlok 71mm Item # 195273Zimmer GmbHJWH
Z-2507-2019Class IIXP-CR Tibial Tray - Interlok 69mm Item # 195272Zimmer GmbHJWH