MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR V…

Recall date

October 9, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0646-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

US Nationwide distribution.

Why it was recalled

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYNJ0532873N; 10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q; 11) MINOR VAGINAL #76-RF, REF DYNJ27434R; 12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I; 13) VAG HYST PACK, REF DYNJ36628L; 14) VAG HYST PACK, REF DYNJ36628M; 15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F; 16) ABDOMINAL HYST PACK, REF DYNJ44848L; 17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O; 19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 20) URO GYN, REF DYNJ50047G; 21) LAVH NEW BRAUNFELS, REF DYNJ61136D; 22) ABDOMINAL PERINEAL, REF DYNJ63371D; 23) ABDOMINAL HYST FFX, REF DYNJ63631A; 24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 25) LAVH PACK, REF DYNJ67210A; 26) VAG MINOR PACK, REF DYNJ82216; 27) VAG MINOR PACK, REF DYNJ82216B; 28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F; 29) VAGINAL, REF DYNJ900292K; 30) GYN LAPAROTOMY, REF DYNJ900296J; 31) LAVH, REF DYNJ900298J; 32) LAVH, REF DYNJ900298K; 33) LITHOTOMY-LF, REF DYNJ900721C; 34) MAJOR VAGINAL-LF, REF DYNJ901807I; 35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F; 36) VAGINAL HYST, REF DYNJ907220A; 37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792; 38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795; 39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B; 40) PRENTICE VAG HYST KIT, REF DYNJ908796; 41) PRENTICE VAG HYST KIT, REF DYNJ908796B; 42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825; 43) KIT PFANNENSTIEL GYN, REF DYNJ908826; 44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837