MEDLINE convenience kits labeled as: GP-LEEP PACK-LF — Class II medical device recall Z-0528-2026
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-0528-2026 |
|---|---|
| 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 | 18 units |
| UPC / GTIN / UDI-DI | 10195327454227, 40195327454228 |
| Lot numbers | 23HDA742 |
| Model numbers | PHS396969004F |
Product
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
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-0528-2026. 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.