510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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

59,460 records, page 176 of 1190
FDA device recalls, page 176 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0604-2024Class IIAbbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire...Abbott MedicalGKZ
Z-0439-2024Class IICardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16ACardioQuipDWC
Z-0438-2024Class IICardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16ACardioQuipDWC
Z-0535-2024Class IIMedline Leg bag, REF URO12573MEDLINE INDUSTRIES, LP - NorthfieldFAQ
Z-0534-2024Class IIMedline Leg bag, REF DYND12578MEDLINE INDUSTRIES, LP - NorthfieldFAQ
Z-0533-2024Class IIMedline Leg bag, REF DYND12574MEDLINE INDUSTRIES, LP - NorthfieldFAQ
Z-0354-2024Class IIModel 97745 Controller used with Models 97715 and 97716 Intellis NeurostimulatorsMedtronic NeuromodulationLGW
Z-0450-2024Class IIMonarch Platform REF MON-000006 100-240V- 50/60Hz 1440wAuris Health, IncEOQ
Z-0449-2024Class IIMonarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440wAuris Health, IncEOQ
Z-0448-2024Class IIMonarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440wAuris Health, IncEOQ
Z-0308-2024Class IILYFO-DISK, P. venetum, Catalog number 0794LMicrobiologics, Inc.JTR
Z-0307-2024Class IIKWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)Microbiologics, Inc.JTR
Z-0517-2024Class IISagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning SystemEckert & Ziegler Bebig GmbHMUJ
Z-0451-2024Class IIBIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine...BioFire Diagnostics, LLCPEN
Z-0523-2024Class IIARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100Siemens Medical Solutions USA, Inc.OWB
Z-0408-2024Class IILugol s Iodine Solution 500ML, Part Number 624-71EMD Millipore CorporationIAM
Z-0353-2024Class IIFilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which...BioFire Diagnostics, LLCNSU
Z-0639-2024Class IIVitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital...Highridge Medical, LLCNKB
Z-0419-2024Class IIPcf-H190l, Evis Exera III ColonovideoscopeAizu Olympus Co., Ltd.FDF
Z-0418-2024Class IIPcf-H190dl, Evis Exera III ColonovideoscopeAizu Olympus Co., Ltd.FDF
Z-0417-2024Class IIGif-Hq190, Evis Exera III Gastrointestinal VideoscopeAizu Olympus Co., Ltd.FDF
Z-0416-2024Class IIGif-H190, Evis Exera III Gastrointestinal VideoscopeAizu Olympus Co., Ltd.FDF
Z-0415-2024Class IICf-Hq190l Evis Exera III ColonovideoscopeAizu Olympus Co., Ltd.FDF
Z-0563-2024Class I(1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes...MEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-0562-2024Class I(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0561-2024Class ITracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction...MEDLINE INDUSTRIES, LP - NorthfieldOGV
Z-0405-2024Class IIwith Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653...Breas Medical ABNOU
Z-0360-2024Class IIAVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038...Halyard HealthBSY
Z-0214-2024Class IIUnity Total Knee System, Model Number 112.001.34. Primary and revision total knee...Corin LimitedJWH
Z-0151-2024Class INovum IQ Syringe infusion system, Product Code 40800BAXUSBaxter Healthcare CorporationFRN
Z-0213-2024Class IIUnity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee...Corin LimitedJWH
Z-0237-2024Class IIChange Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical...Change Healthcare Canada CompanyLLZ
Z-0322-2024Class IIMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5Medtronic, Inc.NTE
Z-0321-2024Class IIMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6Medtronic, Inc.NTE
Z-0320-2024Class IIMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6Medtronic, Inc.NTE
Z-0194-2024Class IEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190OLYMPUS Corporation of the AmericasEOQ
Z-0193-2024Class IEVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190OLYMPUS Corporation of the AmericasEOQ
Z-0192-2024Class IEVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and...OLYMPUS Corporation of the AmericasNWB
Z-0191-2024Class IEVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180OLYMPUS Corporation of the AmericasNWB
Z-0190-2024Class IEVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-ACOLYMPUS Corporation of the AmericasEOQ
Z-0189-2024Class IBRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and...OLYMPUS Corporation of the AmericasEOQ
Z-0290-2024Class IICardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780...Maquet Cardiovascular Us Sales, LLCDTQ
Z-1310-2024Class IINautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support...MC3, Inc.BYS
Z-1309-2024Class IINautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support...MC3, Inc.BYS
Z-0501-2024Class IIRANDOX Total Bilirubin.Randox Laboratories, LimitedJFM
Z-0351-2024Class IIBD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined...Becton Dickinson & CoFPA
Z-0350-2024Class IIBD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS...Becton Dickinson & CoFPA
Z-0234-2024Class IVariSoft infusion set, Model Number 1002830Unomedical A/SFPA
Z-0233-2024Class IVariSoft infusion set, Model Number 1002828Unomedical A/SFPA
Z-0232-2024Class IVariSoft infusion set, Model Number 1002827Unomedical A/SFPA