Medline medical procedure convenience kits labeled as: 1) WCH… — Class II medical device recall Z-1087-2026
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-1087-2026 |
|---|---|
| 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 | 4,536 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10193489569032, 10193489851588, 10195327251420, 10195327415174, 10195327483418, 10195327541378, 10195327541392, 10195327592707, 10198459003950, 10198459008245, 10198459011115, 10198459037863, 10198459047817, 10198459049767, 10198459080494, 10198459104800, 10198459122446, 10198459131066, 10198459148101, 10198459157936, 10198459164507, 10198459203442, 10198459231544, 10198459232626, 10198459236907 and 41 more |
| Lot numbers | 25BBM364, 25BLA967, 25CBA577, 25CBA577Z, 25CBD522, 25CBF096, 25CBM218, 25CBM884, 25CBP413, 25CBT135, 25CDB060, 25CMC374, 25CMC546, 25CMF429, 25CMF465, 25CMF917, 25CMJ006, 25CMJ265, 25CMJ730, 25DBA834, 25DBD145, 25DBD407, 25DBG393, 25DBM322, 25DBR934, 25DBR935, 25DBS537, 25DBT807, 25DDA437, 25DMD329, 25DMG099, 25DMH137, 25DMH506, 25DMJ823, 25DMK337, 25EBB258, 25EBC133, 25EBC253, 25EBC981, 25EBD110 and 33 more |
| Model numbers | CDS860237AF, CDS982128Q, CDS984338M, CDS984640I, DYNJ0525321O, DYNJ57640F, DYNJ62594D, DYNJ63392D, DYNJ68187B, DYNJ82368A, DYNJ85261, DYNJ86178B, DYNJ87610, DYNJ88433, DYNJ900127G, DYNJ901847M, DYNJ901890N, DYNJ903948S, DYNJ904576B, DYNJ905147B, DYNJ905824M, DYNJ905920B, DYNJ905982I, DYNJ906311F, DYNJ906381G and 8 more |
Product
Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHOLE PACK, REF DYNJ57640F; 7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D; 8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D; 9) LAPAROSCOPY PACK, REF DYNJ68187B; 10) LAPAROSCOPY PACK, REF DYNJ82368A; 11) ROBOTIC KIDNEY PACK, REF DYNJ85261; 12) DOWNTOWN ROBOTICS, REF DYNJ86178B; 13) DAVINCI LITHOTOMY PACK, REF DYNJ87610; 14) ROBOTIC WHIPPLE PACK, REF DYNJ88433; 15) PROSTATE DAVINCI, REF DYNJ900127G; 16) GENERAL LAPAROSCOPY, REF DYNJ901847M; 17) LAG TLH, REF DYNJ901890N; 18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S; 19) LAP, REF DYNJ904576B; 20) ROBOTIC, REF DYNJ905147B; 21) ROBOTICS GYN, REF DYNJ905824M; 22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B; 23) CHN OR BASIC ROBOTIC, REF DYNJ905982I; 24) KIT ROBOTIC RFD, REF DYNJ906311F; 25) ROBOTIC PROSTATE, REF DYNJ906381G; 26) DAVINCI, REF DYNJ907392C; 27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C; 28) GYN, REF DYNJ908504B; 29) UROLOGY ROBOTIC, REF DYNJ908588I; 30) THORACIC ROBOTICS, REF DYNJ908777A; 31) GENERAL ROBOT, REF DYNJ908969A; 32) KIT ROBOTIC, REF DYNJ909870B; 33) ROBOTIC THORACOSCOPY, REF DYNJ910924.
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-1087-2026. 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.