Medline medical procedure convenience kits labeled as: 1) LAVH… — Class II medical device recall Z-1089-2026
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-1089-2026 |
|---|---|
| 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 | 1,457 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10195327306793, 10195327312565, 10195327391249, 10195327393014, 10195327464929, 10195327699154, 10198459043086, 10198459050398, 10198459121814, 10198459131042, 10198459202025, 10198459204326, 10198459231384, 40195327306794, 40195327312566, 40195327391240, 40195327393015, 40195327464920, 40195327699155, 40198459043087, 40198459050399, 40198459121815, 40198459131043, 40198459202026, 40198459204327 and 1 more |
| Lot numbers | 25BBL633, 25BBS130, 25BBU206, 25BDB095, 25CBJ298, 25CBJ496, 25CBL184, 25CBN230, 25CBS527, 25CBU642, 25CMJ281, 25DBC272, 25DBG283, 25DBH895, 25DBJ371, 25DBM353, 25DDA191, 25EBE453, 25EBK493, 25EBK650, 25EBP591, 25EBP700, 25EBR237, 25EMD795, 25FBA261, 25FBC561, 25FBF371, 25FBJ430, 25FBJ689, 25FBK918, 25FDB398, 25FMC511 |
| Model numbers | CDS980754T, CDS982662Q, CDS985344F, DYNJ900244I, DYNJ901281I, DYNJ901829T, DYNJ902030J, DYNJ905274D, DYNJ905485J, DYNJ906380C, DYNJ910634, DYNJ910927, DYNJQ9041R |
Product
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.
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-1089-2026. 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.