The Recall Desk
Severity pendingFDA (Devices)·Z-0523-2026·Announced 2025-11-26

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

Pending LLM rewrite. Source: FDA_DEVICE Z-0523-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 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

Distributed nationwide across the United States.

Related recalls

Same category