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 362 of 1190
FDA device recalls, page 362 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0879-2020Class II2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product...Synthes GmbHHRS
Z-0819-2020Class IICentricity Universal Viewer 6.0, a device that displays medical images and data from...GE HealthcareLLZ
Z-0878-2020Class IILEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF...Smith & Nephew, Inc.MBH
Z-0812-2020Class IIMicrobiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated...Microbiologics, Inc.OHQ
Z-1674-2020Class IIBeckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI...Siemens Healthcare Diagnostics Inc.LIE
Z-1115-2020Class IHUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414...Teleflex MedicalBTT
Z-1114-2020Class IHUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kitTeleflex MedicalBTT
Z-1113-2020Class IHUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF...Teleflex MedicalBTT
Z-1112-2020Class IHUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer...Teleflex MedicalBTT
Z-1100-2020Class IIILiquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 mlRandox Laboratories, LimitedJJY
Z-0798-2020Class IIADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The...CooperSurgical, Inc.HIH
Z-1000-2020Class IICoonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No...Zimmer GmbHJDC
Z-0844-2020Class IIArrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-0915-2020Class IResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150ResMed CorpMNT
Z-0794-2020Class IIONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K...Baxter Healthcare CorporationFPA
Z-0793-2020Class IIClearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and...Baxter Healthcare CorporationFPA
Z-2361-2020Class IIPiccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55...Abaxis IncJJG
Z-1095-2020Class IICenturion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING...Centurion Medical Products, LPPXP
Z-1094-2020Class IICenturion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL...Centurion Medical Products, LPLRP
Z-1093-2020Class IICenturion- PT225 PAIN MANAGEMENT TRAYCenturion Medical Products, LPLRO
Z-1092-2020Class IICenturion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE...Centurion Medical Products, LPOJU
Z-1091-2020Class IICenturion- ENT SNUF3 SNUFFER KIT YCenturion Medical Products, LPOGR
Z-1090-2020Class IICenturion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAYCenturion Medical Products, LPOJU
Z-1089-2020Class IICenturion- Nasal Speculum NSP500ST STERILE NASAL SPECULUMCenturion Medical Products, LPOGR
Z-1088-2020Class IICenturion- OR2020 BASIN SETCenturion Medical Products, LPLRP
Z-1087-2020Class IICenturion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING...Centurion Medical Products, LPOXQ
Z-1086-2020Class IICenturion- LC145 STERILE NICU LINE CHANGE KITCenturion Medical Products, LPOXQ
Z-1085-2020Class IICenturion- Port Draw Kit KNV30 PORT DRAW KITCenturion Medical Products, LPOIB
Z-1084-2020Class IICenturion IVS3505 ULTRASOUND GUIDED PIV KITCenturion Medical Products, LPLRP
Z-1083-2020Class IICenturion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD YCenturion Medical Products, LPLRP
Z-1082-2020Class IICenturion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)Centurion Medical Products, LPPRR
Z-1081-2020Class IICenturion- I86625 DEBRIDEMENT TRAYCenturion Medical Products, LPLRP
Z-1080-2020Class IICenturion- HT5555A HYPERALIMENTATION & DRSG CHG TRAYCenturion Medical Products, LPOXQ
Z-1079-2020Class IICenturion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000...Centurion Medical Products, LPKYW
Z-1078-2020Class IICenturion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILECenturion Medical Products, LPKYW
Z-1077-2020Class IICenturion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLECenturion Medical Products, LPKCZ
Z-1076-2020Class IICenturion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN...Centurion Medical Products, LPLRP
Z-1075-2020Class IICenturion-Suture Tray DYNDR1210A SUTURING TRAYCenturion Medical Products, LPLRP
Z-1074-2020Class IICenturion-Skin Prep Tray DYNDP1015 SKIN PREP TRAYCenturion Medical Products, LPOJU
Z-1073-2020Class IICenturion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM...Centurion Medical Products, LPLRP
Z-1072-2020Class IICenturion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHTCenturion Medical Products, LPMLT
Z-1071-2020Class IICenturion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEMCenturion Medical Products, LPOXQ
Z-1070-2020Class IICenturion- Biopsy Tray TRIBT170 BIOPSY TRAYCenturion Medical Products, LPLRP
Z-1069-2020Class IICenturion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE...Centurion Medical Products, LPLRQ
Z-1068-2020Class IICenturion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790Centurion Medical Products, LPHHM
Z-1067-2020Class IICenturion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR...Centurion Medical Products, LPFMH
Z-1066-2020Class IICenturion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE...Centurion Medical Products, LPLRQ
Z-1065-2020Class IICenturion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE...Centurion Medical Products, LPLRP
Z-1064-2020Class IICenturion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY...Centurion Medical Products, LPOHG
Z-1063-2020Class IICenturion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM...Centurion Medical Products, LPOXQ