Medline Industries, LP recalls MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF

Recalling company

Medline Industries, LP

Product

MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 7) URO GYN, REF DYNJ50047G; 8) ISS VAG HYST PACK, REF DYNJ50315F; 9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B; 10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 11) LAVH, REF DYNJ900298L; 12) LITHOTOMY-LF, REF DYNJ900721C; 13) GP-T A H PACK-LF, REF PHS396954006G; 14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F.

Reason

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 30, 2025

Reported

Nov 26, 2025

Distribution

US Nationwide distribution.

Status

Ongoing

Quantity

570 kits

Lot / codes

1) REF DYNJ0160684F: UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers: 23DDC245, 23GDC219; 2) REF DYNJ0425778O: UDI/DI 10198459082290 (each) 40198459082291 (case), Lot Numbers: 24LMF192; 3) REF DYNJ27434R: UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers: 24BBR389, 24CBH709; 4) REF DYNJ44848M: UDI/DI 10195327415952 (each) 40195327415953 (case), Lot Numbers: 23EDB911, 23FDC315, 23HDA180; 5) REF DYNJ44863Q: UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers: 23FDB122, 23GDC100; 6) REF DYNJ44900P: UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers: 23DDB824, 23EDA215, 23FDB287; 7) REF DYNJ50047G: UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers: 24BBE163, 24DBO682; 8) REF DYNJ50315F: UDI/DI 10195327535353 (each) 40195327535354 (case), Lot Numbers: 23KMF190; 9) REF DYNJ60554B: UDI/DI 10195327361747 (each) 40195327361748 (case), Lot Numbers: 23EBD224, 23KBE886; 10) REF DYNJ67194B: UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers: 23HBN435; 11) REF DYNJ900298L: UDI/DI 10195327554170 (each) 40195327554171 (case), Lot Numbers: 23LBF269, 23LBT933, 24BBT248; 12) REF DYNJ900721C: UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers: 23HBW996; 13) REF PHS396954006G: UDI/DI 10195327454159 (each) 40195327454150 (case), Lot Numbers: 23HDB088; 14) REF PHS396975006F: UDI/DI 10195327454166 (each) 40195327454167 (case), Lot Numbers: 23JDB593.

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-0527-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0527-2026 in the FDA Enforcement Report. Also see FDA recall press releases.