FDA-Device2026-01-21Class IIPROCESSING DEFECT

Medline surgical procedure kits with Stryker Strykeflow 2 Suction Irrigators recalled for leaking and vapor emission

BURNELECTRICAL SHOCKOTHERNationwide distributionMedical devices Baby & kids

What this means

Medline medical procedure convenience kits containing Stryker's Strykeflow 2 Suction Irrigators have a design flaw that allows irrigation solution to leak into the handpiece and battery pack during use. Some devices have leaked fluid or emitted vaporized saline that may resemble smoke during procedures.

Check if your surgical kit matches one of the recalled reference numbers (e.g., CDS860237AF, DYNJ0525321O, DYNJ57640F, DYNJ62594D, or others listed in the recall)
Stop using any affected kit immediately
Contact Medline Industries or your hospital supply manager for instructions on return or replacement
Report any leaks or device malfunctions to Medline or the FDA

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

US Nationwide distribution.

Affected count

4536 units

Manufactured in

3 Lakes Dr, Northfield, IL, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1087-2026

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