Recall archive / FDA device enforcement
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CD... — FDA record Z-0524-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 30, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 2844 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0524-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 26, 2025
- Recall initiation date
- Sep 30, 2025
- Center classification date
- Nov 14, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.