Medline medical procedure convenience kits labeled as: 1) RR-GYN… — Class II medical device recall Z-1197-2026
Ongoing recall by Medline Industries, LP, reported 2026-02-04, distributed nationwide. Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to c
| Recall number | Z-1197-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-12-12 |
| Classified | 2026-01-28 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,928 total |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10195327127626, 10195327634827, 10198459039232, 10198459344053, 10198459388002, 10198459440953, 10198459460098, 10198459566806, 40195327127627, 40195327634828, 40198459039233, 40198459344054, 40198459388003, 40198459440954, 40198459460099, 40198459566807 |
| Lot numbers | 25KMD772, 25KME682, 25KMF328, 25KMH125, 25KMJ341, 25LMA115, 25LMA391, 25LMA516 |
Product
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU DYNJ50880L; 6) DELNOR LAPAROSCOPIC GYN PACK, Kit SKU DYNJ82244B; 7) ROBOT PACK, Kit SKU DYNJ82761B; 8) GENERAL ROBOTICS PACK, Kit SKU DYNJT4964.
Reason for recall
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
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-1197-2026. 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.