FDA recall Z-0646-2025

Product

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 H

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-10-09

Report date

2024-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0646-2025