Recall
FDAHealthSeptember 30, 2025

Medline Industries, LP — MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
September 30, 2025

US Nationwide distribution.

What's affected?

Product
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
Lot code
23FDA201

Additional details

1) REF DYNJ0161768G: UDI/DI 10195327404567 (each) 40195327404568 (case), Lot Numbers: 23FDA201, 23HDB248; 2) REF DYNJ67757B: UDI/DI 10195327228002 (each) 40195327228003 (case), Lot Numbers: 23EBK325, 23HBM888, 23IBP459, 23JBV413.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 424 kits.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.