Medline convenience kits labeled as: 1) GYN ROBOTIC CDS — Class II medical device recall Z-3025-2026
Ongoing recall by Medline Industries, LP, reported 2026-09-02, distributed nationwide. Kits contain a potentially contaminated component which were recalled by the manufacturer
| Recall number | Z-3025-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-07-10 |
| Classified | 2026-08-26 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,349 kits |
| UPC / GTIN / UDI-DI | 10195327609627, 10195327609733, 10195327657222, 10198459255083, 10198459289286, 10198459289521, 10198459501616, 10198459510144, 10198459520532, 10198459521959, 10198459539886, 10198459556579, 10198459556586, 10198459602283, 10198459611025, 10198459716799, 40195327609628, 40195327609734, 40195327657223, 40198459255084, 40198459289287, 40198459289522, 40198459501617, 40198459510145, 40198459520533 and 7 more |
| Lot numbers | 25HDB674, 25IBP437, 25ILA566, 25JBL333, 25JBS159, 25JBT511, 25KBE469, 25KBF320, 25KBH190, 25KBN172, 25KLA664, 25KMH001, 26ABN671, 26ADA977, 26AMD191, 26AME001, 26AMH304, 26BBF959, 26CBS107, 26DBT722, 26DMF990, 26FBU894, DYNJ912062 |
Product
Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline Kit SKU DYNJ900203N; 6) GYN LAPAROSCOPY, Medline Kit SKU DYNJ900541Q; 7) ROBOTIC, Medline Kit SKU DYNJ903485K; 8) ROBOTIC GYN, Medline Kit SKU DYNJ905230K; 9) LAPAROSCOPIC GYN AND COLON, Medline Kit SKU DYNJ906013I; 10) GYN LAPAROSCOPIC PACK, Medline Kit SKU DYNJ909394B; 11) GYN ROBOTIC, Medline Kit SKU DYNJ909526B; 12) GYN ROBOTIC, Medline Kit SKU DYNJ909526C; 13) GYN ONC ROBOTIC, Medline Kit SKU DYNJ910180; 14) GYN ROBOTIC, Medline Kit SKU DYNJ910181; 15) GYN ROBOTIC, Medline Kit SKU DYNJ910181A; 16) ROBOTICS, Medline Kit SKU DYNJ912062.
Reason for recall
Kits contain a potentially contaminated component which were recalled by the manufacturer
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-3025-2026. 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.