Reported Nov 26, 2025 · Ongoing
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF…
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- MEDLINE convenience kits labeled as
1) MAJOR VAGINAL HARPER PACK-LFREF DYNJ0161768G2) ACH MAJOR VAGINAL PACKREF DYNJ67757B
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published DYNJ0161768G1019532740456740195327404568UDI/DI 10195327404567 (each) 40195327404568 (case) — Lot Numbers: 23FDA201, 23HDB248; 2) DYNJ67757B1019532722800240195327228003UDI/DI 10195327228002 (each) 40195327228003 (case) — Lot Numbers: 23EBK325, 23HBM888, 23IBP459, 23JBV413. - Amount recalled
- 424 kits
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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