FDA Medical devices recall · January 21, 2026

Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY… recall

Read the official FDA notice ↗

Product

Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF, REF CDS984016B; 7) LAP CHOLE KIT, REF CDS984020P; 8) LAP CHOLE-LF, REF CDS984175J; 9) LAP COLON CDS, REF CDS984849N; 10) GENERAL LAPAROSCOPY CDS, REF CDS985328M; 11) LAP CHOLE, REF DYNJQ9044O; 12) GENERAL LAPAROSCOPY V, REF DYNJS2032F; 13) LAP CHOLE PACK, REF DYNJ26209R; 14) LAP CHOLE PACK, REF DYNJ26209S; 15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D; 16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G; 17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G; 18) LAP CHOLE PACK, REF DYNJ51785D; 19) LAPAROSCOPY PACK, REF DYNJ61652A; 20) ENDOSCOPY, REF DYNJ62133A; 21) LAP CHOLE PACK, REF DYNJ66285A; 22) LAPAROSCOPY PACK, REF DYNJ66289B; 23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D; 24) LAPAROSCOPY PACK, REF DYNJ68187A; 25) LAP OB PACK, REF DYNJ68741A; 26) LAP CHOLE PACK-LF, REF DYNJ81408A; 27) LAP CHOLE PACK-LF, REF DYNJ81408B; 28) LAP CHOLE PACK, REF DYNJ85318; 29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677; 30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J; 31) LAP CHOLE, REF DYNJ901126G; 32) BARIATRIC KIT, REF DYNJ901145I; 33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M; 34) LAP GASTRIC SLEEVE, REF DYNJ901504L; 35) GENERAL LAP GASTRIC, REF DYNJ901827X; 36) GENERAL LAPAROSCOPY, REF DYNJ901847N; 37) LOU LAP SIGMOID COLON, REF DYNJ901848L; 38) LAP CHOLE, REF DYNJ901870J; 39) LEX BARIATRIC, REF DYNJ902033L; 40) BARIATRIC, REF DYNJ902515K; 41) LAP CHOLE CDS, REF DYNJ902565K; 42) LAP CHOLE, REF DYNJ902995I; 43) LAP CHOLE, REF DYNJ903163L; 44) LAP APPY, REF DYNJ903164L; 45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C; 46) LAP CHOLE, REF DYNJ904693D; 47) BARIATRIC, REF DYNJ904891N; 48) LAPAROSCOPY, REF DYNJ905071F; 49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F; 50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G; 51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D; 52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A; 53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B; 54) LAP BARIATRIC, REF DYNJ905733K; 55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A; 56) LAP CHOLE, REF DYNJ906277D; 57) LAP CHOLE RFD, REF DYNJ906302D; 58) KIT LAP COLON RFD, REF DYNJ906315D; 59) GASTRIC SLEEVE, REF DYNJ906355D; 60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C; 61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C; 62) GEN BARIATRIC, REF DYNJ907639D; 63) LAP CHOLE, REF DYNJ908415B; 64) LAP CHOLE, REF DYNJ908415C; 65) LAPAROSCOPIC, REF DYNJ908569B; 66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G; 67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A; 68) BARIATRIC CENTRASTATE, REF DYNJ909817A; 69) LAP GENERAL THEDA, REF DYNJ910050; 70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A; 71) ROBOTIC THORACIC, REF DYNJ910386; 72) BARIATRIC, REF DYNJ911017.

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMH913; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMC376; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CMJ688; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CME476; REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25EBM987; REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25CBT666; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25FBP815; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25EBN002; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25CBN212; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25FBN760; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25EBD329; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBN040; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBK313; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25CBE452; REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMH793; REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMC405; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25EBN676; REF

Distribution

US Nationwide distribution.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1086-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.