Medline Industries, LP: Medical Device Recall in 2025 - (Recall #: Z-0523-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 30, 2025

Date Posted: November 26, 2025

Recall Number: Z-0523-2026

Event ID: 97846

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 424 kits

Code Information:

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.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated