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 169 of 1190
FDA device recalls, page 169 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0885-2024Class IIScorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part...Howmedica Osteonics CorpJWH
Z-0884-2024Class IIScorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part...Howmedica Osteonics CorpJWH
Z-0883-2024Class IIScorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number...Howmedica Osteonics CorpJWH
Z-0882-2024Class IISCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524Howmedica Osteonics CorpJWH
Z-0881-2024Class IISCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521Howmedica Osteonics CorpJWH
Z-0880-2024Class IISCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518Howmedica Osteonics CorpJWH
Z-0879-2024Class IISCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516Howmedica Osteonics CorpJWH
Z-0878-2024Class IISCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514Howmedica Osteonics CorpJWH
Z-0877-2024Class IISCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512Howmedica Osteonics CorpJWH
Z-0876-2024Class IISCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510Howmedica Osteonics CorpJWH
Z-0875-2024Class IISCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321Howmedica Osteonics CorpJWH
Z-0874-2024Class IISERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524Howmedica Osteonics CorpJWH
Z-0873-2024Class IISERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515Howmedica Osteonics CorpJWH
Z-0872-2024Class IISCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032Howmedica Osteonics CorpJWH
Z-0871-2024Class IISCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030Howmedica Osteonics CorpJWH
Z-0870-2024Class IISCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028Howmedica Osteonics CorpJWH
Z-0869-2024Class IISCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026Howmedica Osteonics CorpJWH
Z-0748-2024Class IISOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S...OLYMPUS Corporation of the AmericasGEX
Z-0724-2024Class IIVasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.Maquet Cardiovascular LLCGEI
Z-0723-2024Class IIVasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .Maquet Cardiovascular LLCGEI
Z-0750-2024Class IIGammaPod - Treatment Planning System-a component of the GammaPod Irradiation System...Xcision Medical Systems, LLCIWB
Z-0749-2024Class IILink Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as...Waldemar Link GmbH & Co. KGFZX
Z-0679-2024Class IIBrightView XCT, Gamma Camera, Product Code 882482Philips North America LLCKPS
Z-0678-2024Class IIBrightView X, Gamma Camera, Product Code 882478Philips North America LLCKPS
Z-0677-2024Class IIBrightView, Gamma Camera System, Product Code 882480.Philips North America LLCKPS
Z-0725-2024Class IISpectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.Philips North America LLCJAK
Z-0813-2024Class IIbkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.BK Medical ApSIYN
Z-0594-2024Class ICatalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREEBusse Hospital DisposablesNXA
Z-0593-2024Class ICatalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREEBusse Hospital DisposablesMCY
Z-0592-2024Class ICatalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREEBusse Hospital DisposablesNXA
Z-0673-2024Class IIBoston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed...Boston Scientific CorporationLWS
Z-0591-2024Class IOmnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3...Insulet CorporationQFG
Z-0992-2024Class IIRX Series Copper (Cu) Assay Ref. Number CU2340Randox Laboratories, LimitedJKZ
Z-0833-2024Class IICustom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP...American Contract Systems, Inc.OJH
Z-0832-2024Class IICustom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK...American Contract Systems, Inc.OJK
Z-0831-2024Class IICustom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled...American Contract Systems, Inc.OJF
Z-0830-2024Class IICustom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled...American Contract Systems, Inc.OHM
Z-0829-2024Class IICustom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled...American Contract Systems, Inc.MLS
Z-0828-2024Class IICustom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled...American Contract Systems, Inc.OHD
Z-0827-2024Class IICustom procedural convenience kits and trays, general hospital use, labeled as: a) IR...American Contract Systems, Inc.OJG
Z-0826-2024Class IICustom procedural convenience kits and trays, general hospital use, labeled as: a) Baby...American Contract Systems, Inc.OKE
Z-0825-2024Class IICustom procedural convenience kits and trays, general & plastic surgery, labeled as...American Contract Systems, Inc.LRO
Z-0824-2024Class IICustom procedural convenience kits and trays, general & plastic surgery, labeled as: a)...American Contract Systems, Inc.FTN
Z-0823-2024Class IICustom procedural convenience kits and trays, urological, labeled as: a) UROLOGY...American Contract Systems, Inc.FDE
Z-0822-2024Class IICustom procedural convenience kits and trays, gastroenterological & urological, labeled...American Contract Systems, Inc.FDE
Z-0821-2024Class IICustom procedural convenience kits and trays, gastroenterological & urological, labeled...American Contract Systems, Inc.FCH
Z-0820-2024Class IICustom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND...American Contract Systems, Inc.OGR
Z-0819-2024Class IICustom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE...American Contract Systems, Inc.OFF
Z-0818-2024Class IIProcedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT...American Contract Systems, Inc.OEZ
Z-0817-2024Class IICustom procedural convenience kits and trays, cardiac, labeled as: a) HEART...American Contract Systems, Inc.OES