Medline medical procedure convenience kits labeled as: 1) THORACIC… — Class II medical device recall Z-1085-2026
Ongoing recall by Medline Industries, LP, reported 2026-01-21, distributed nationwide. Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigatio
| Recall number | Z-1085-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-12-16 |
| Classified | 2026-01-14 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 96 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10198459269196, 10198459326318, 40198459269197, 40198459326319 |
| Lot numbers | 25EBD732, 25FBA103 |
| Model numbers | DYNJ908777B, DYNJ911359 |
Product
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Reason for recall
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
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-1085-2026. 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.