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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2111-2026

Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Model Number: DYNJ0547084O; 6) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 7) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 8) VAG HYST PACK, Model Number: DYNJ31344J; 9) VAG HYST PACK, Model Number: DYNJ31344K; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 12) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 13) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 14) LAVH PACK, Model Number: DYNJ36712F; 15) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 16) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 17) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 18) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 19) LAVH - N #668629 -N, Model Number: DYNJ58121C; 20) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 21) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 22) D AND C PACK, Model Number: DYNJ61282B; 23) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 24) PERI GYN, Model Number: DYNJ67708A; 25) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 26) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 27) ANORECTAL PACK, Model Number: DYNJ83560; 28) D&C CDS, Model Number: DYNJ902560I; 29) HYSTEROSCOPY, Model Number: DYNJ903327K; 30) HYSTEROSCOPY, Model Number: DYNJ903475I; 31) ROBOTIC HYST, Model Number: DYNJ903798G; 32) TLH KIT, Model Number: DYNJ908149; 33) LAVH TOTE, Model Number: DYNJ908340; 34) LAVH TOTE, Model Number: DYNJ908340A; 35) LAVH TOTE, Model Number: DYNJ908340B; 36) LAVH TOTE, Model Number: DYNJ908340D; 37) LAVH, Model Number: DYNJ908986; 38) LAVH, Model Number: DYNJ908986A; 39) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 40) LAVH GYN/ONC, Model Number: DYNJ910927; 41) VAG HYST PACK, Model Number: DYNJT3348; 42) LAVH PART B, Model Number: DYNJV0312G

Publicado el 13 de mayo de 2026 · Inicio del retiro: 7 de enero de 2026

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medline Industries, LP
Distribuidor
Worldwide - US Nationwide distribution.
Lote
1) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23GBE705; 2) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23HBY878; 3) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23IBV204; 4) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24ABO363; 5) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24CBQ563; 6) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH028; 7) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH032; 8) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH451; 9) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBL440; 10) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBS135; 11) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBC116; 12) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBD256; 13) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23HBI773; 14) DYNJ0373807J, UDI-DI: 10193489942996(each), 40193489942997(case), Lot Number: 22EBC904; 15) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22HBV873; 16) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22JBO175; 17) DYNJ0547084O, UDI-DI: 10193489888379(each), 40193489888370(case), Lot Number: 23KME941; 18) DYNJ21824R, UDI-DI: 10195327107758(each), 40195327107759(case), Lot Number: 23EBT744; 19) DYNJ27434R, UDI-DI: 10195327107727(each), 40195327107728(case), Lot Number: 23EBQ683; 20) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21ABP592; 21) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21CBJ513; 22) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21LBL067; 23) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22CBV220; 24) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22KMC218; 25) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 23CMG183; 26) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 22LME145; 27) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23BMG588; 28) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23EMG111; 29) DYNJ33393M, UDI-DI: 10195327567323(each), 40195327567324(case), Lot Number: 24AMC141; 30) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24HMH344; 31) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24LME743; 32) DYNJ33393O, UDI-DI: 10198459244537(each), 40198459244538(case), Lot Number: 25CMI389; 33) DYNJ36712F, UDI-DI: 10195327148027(each), 40195327148028(case), Lot Number: 22KBH638; 34) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 21LBI132; 35) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22ABL203; 36) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22BBZ962; 37) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22EBK097; 38) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22GBK309; 39) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23BBC494; 40) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23DBD471; 41) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23FBJ953; 42) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23GBF010; 43) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23HBF942; 44) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21DBN261; 45) DYNJ45801C, UDI-DI: 101934898
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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