Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY Recalled by Medline Industries, LP Due to Medline kits containing Stryker's Strykeflow 2 Suction Irrigators...

Date: December 16, 2025
Company: Medline Industries, LP
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medline Industries, LP directly.

Affected 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.

Quantity: 4536 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medline Industries, LP

Medline Industries, LP has 182 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report