MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF — Class II medical device recall Z-0524-2026
Ongoing recall by Medline Industries, LP, reported 2025-11-26, distributed nationwide. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir
| Recall number | Z-0524-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-09-30 |
| Classified | 2025-11-14 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 2,844 kits |
| UPC / GTIN / UDI-DI | 10195327127626, 10195327140656, 10195327191474, 10195327241735, 10195327243166, 10195327298418, 10195327304201, 10195327417987, 10195327420826, 10195327425524, 10195327445096, 10195327451219, 10195327454142, 10195327486921, 10195327554088, 10195327554194, 10195327554200, 10195327561956, 10195327598112, 10195327647704, 40195327127627, 40195327140657, 40195327191475, 40195327241736, 40195327243167 and 15 more |
| Lot numbers | 23DBJ145, 23DBJ363, 23DBK217, 23EBU559, 23EDB052, 23EMH332, 23FBS005, 23FMD177, 23GBO806, 23GBP632, 23GBT512, 23GDB708, 23GDB759, 23HBI619, 23HBJ772, 23HBL687, 23HBO463, 23HDB026, 23HMB194, 23IBP551, 23JBD927, 23JBF467, 23JBH964, 23JMA672, 23JMC169, 23JMC442, 23JMG251, 23KMC642, 23KME178, 23LBF280, 23LBG402, 23LBG811, 23LBN095, 23LBO223, 23LBV707, 23LMC669, 24ABC736, 24ABP835, 24ABS777, 24ABT614 and 20 more |
| Model numbers | CDS920099S, CDS983764J, CDS984262N, CDS984262P, DYNJ38844N, DYNJ44864S, DYNJ44876M, DYNJ45184F, DYNJ52524D, DYNJ64234C, DYNJ65373A, DYNJ67190C, DYNJ86154, DYNJ900296K, DYNJ900300K, DYNJ900301K, DYNJ903539G, DYNJ904250I, DYNJ907910B, PHS504647004G |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0524-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.