Medline Industries, LP recalls Medline Convenience Kits: 1) HYSTEROSCOPY

Recalling company

Medline Industries, LP

Product

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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jan 7, 2026

Reported

May 13, 2026

Distribution

Worldwide - US Nationwide distribution.

Status

Ongoing

Quantity

6676 units

Lot / codes

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), 4019348

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-2111-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2111-2026 in the FDA Enforcement Report. Also see FDA recall press releases.