BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 7) LAP-GYN PACK, REF DYNJ44876M; 8) ROBOT PACK, REF DYNJ45184F; 9) GYN LAP PACK, REF DYNJ52524D; 10) GYN LAP PACK, REF DYNJ64234C; 11) GYN DAVINCI PACK, REF DYNJ65373A; 12) ROBOT PACK, REF DYNJ67190C; 13) ROBOTIC PACK, REF DYNJ86154; 14) GYN LAPAROTOMY, REF DYNJ900296K; 15) ROBOT THOR, REF DYNJ900300K; 16) ROBOT URO, REF DYNJ900301K; 17) SM DAVINCI, REF DYNJ903539G; 18) ROBOTIC PACK-LF, REF DYNJ904250I; 19) ROBOTIC-LF, REF DYNJ907910B; 20) GP-ROBOTIC PACK-LF, REF PHS504647004G.

    Recall: Z-0524-2026 · Reported November 26, 2025

    Enforcement

    Recall Number
    Z-0524-2026
    Event ID
    97846
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 26, 2025
    Initiation Date
    September 30, 2025
    Classification Date
    November 14, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 7) LAP-GYN PACK, REF DYNJ44876M; 8) ROBOT PACK, REF DYNJ45184F; 9) GYN LAP PACK, REF DYNJ52524D; 10) GYN LAP PACK, REF DYNJ64234C; 11) GYN DAVINCI PACK, REF DYNJ65373A; 12) ROBOT PACK, REF DYNJ67190C; 13) ROBOTIC PACK, REF DYNJ86154; 14) GYN LAPAROTOMY, REF DYNJ900296K; 15) ROBOT THOR, REF DYNJ900300K; 16) ROBOT URO, REF DYNJ900301K; 17) SM DAVINCI, REF DYNJ903539G; 18) ROBOTIC PACK-LF, REF DYNJ904250I; 19) ROBOTIC-LF, REF DYNJ907910B; 20) GP-ROBOTIC PACK-LF, REF PHS504647004G.

    Reason

    Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

    Code Info

    REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 23LBV707; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24CBD429; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24CBD498; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24DBK836; REF CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 24HBE577; REF CDS983764J: UDI/DI 10195327451219 (each) 40195327451210 (case), Lot Numbers: 23HBO463; REF CDS983764J: UDI/DI 10195327451219 (each) 40195327451210 (case), Lot Numbers: 23JBF467; REF CDS984262N: UDI/DI 10195327241735 (each) 40195327241736 (case), Lot Numbers: 24ABP835; REF CDS984262P: UDI/DI 10195327647704 (each) 40195327647705 (case), Lot Numbers: 24CBK422; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23GBT512; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23HBI619; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23LBN095; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24BBR322; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24DBA027; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24DBT103; REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 24EBG556; REF DYNJ44864S: UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 23GBO806; REF DYNJ44864S: UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 23HBJ772; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23EDB052; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23GDB708; REF DYNJ44876M: UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 23GDB759; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23DBJ363; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23EBU559; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23HBL687; REF DYNJ45184F: UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 23JBD927; REF DYNJ52524D: UDI/DI 10195327561956 (each) 40195327561957 (case), Lot Numbers: 23LBG811; REF DYNJ52524D: UDI/DI 10195327561956 (each) 40195327561957 (case), Lot Numbers: 24BBQ970; REF DYNJ64234C: UDI/DI 10195327486921 (each) 40195327486922 (case), Lot Numbers: 23JMA672; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23EMH332; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23FMD177; REF DYNJ65373A: UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23HMB194; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23DBJ145; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23DBK217; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23FBS005; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23GBP632; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23IBP551; REF DYNJ67190C: UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23JBH964; REF DYNJ86154: UDI/DI 10195327598112 (each) 40195327598113 (case), Lot Numbers: 24CBA421; REF DYNJ900296K: UDI/DI 10195327554088 (each) 40195327554089 (case), Lot Numbers: 23LBG402; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 23LBF280; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 23LBO223; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 24ABV771; REF DYNJ900300K: UDI/DI 10195327554194 (each) 40195327554195 (case), Lot Numbers: 24CBC856; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24ABS777; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24BBB142; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24CBI705; REF DYNJ900301K: UDI/DI 10195327554200 (each) 40195327554201 (case), Lot Numbers: 24EBN319; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMC169; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMC442; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23JMG251; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23KMC642; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23KME178; REF DYNJ903539G: UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23LMC669; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24ABT614; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24DBM183; REF DYNJ904250I: UDI/DI 10195327420826 (each) 40195327420827 (case), Lot Numbers: 24EBJ705; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24ABC736; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24DBD770; REF DYNJ907910B: UDI/DI 10195327445096 (each) 40195327445097 (case), Lot Numbers: 24EBH118; REF PHS504647004G: UDI/DI 10195327454142 (each) 40195327454143 (case), Lot Numbers: 23HDB026.

    Distribution

    US Nationwide distribution.

    Quantity

    2844 kits