Medline recalls specific convenience kits with SafeAir Smoke Evacuation Pencils that may activate without manual input when plugged in or remain active after button release. Affected units include certain model numbers and lot numbers from 2024.
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.
Medline is recalling specific convenience kits containing SafeAir Smoke Evacuation Pencils because they might activate without manual input when plugged in or stay active after buttons are released. This could lead to unintended smoke evacuation in emergencies.
The SafeAir Smoke Evacuation Pencils may activate without manual input when plugged into a power source or remain active after buttons are released. This could cause unintended smoke evacuation during emergencies, potentially disrupting medical procedures or creating hazards.
Users of Medline convenience kits with SafeAir Smoke Evacuation Pencils labeled as MAJOR VAGINAL HARPER PACK-LF (REF DYNJ0161768G) or ACH MAJOR VAGINAL PACK (REF DYNJ67757B) are affected. Healthcare workers using these kits in medical settings are most at risk.
Check for convenience kits labeled as MAJOR VAGINAL HARPER PACK-LF (REF DYNJ0161768G) or ACH MAJOR VAGINAL PACK (REF DYNJ67757B). Affected units have specific lot numbers: 23FDA201, 23HDB248 for the first model, and 23EBK325, 23HBM888, 23IBP459, 23JBV413 for the second model.
Look for the model numbers and lot numbers listed in the recall notice to confirm if your kit is affected.
Reach out to Medline Industries for specific guidance on whether your product is included in the recall.
The SafeAir Smoke Evacuation Pencils may activate without manual input when plugged in or remain active after buttons are released, which could cause unintended smoke evacuation during emergencies.
Check the product labels for the model numbers and lot numbers listed in the recall notice. Contact Medline Industries for specific guidance on whether your product is affected.
Yes, the product may activate without manual input or remain active after buttons are released, which could lead to unintended smoke evacuation during emergencies.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0523-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-0523-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
