Medline recalls specific breast biopsy kits with SafeAir Smoke Evacuation Pencils that may activate without manual input when plugged in or remain active after button release. Affected kits include models DYNJ0160598C, DYNJ65361A, and DYNJ908839A.
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 breast biopsy kits that contain SafeAir Smoke Evacuation Pencils. These pencils could activate without manual input when plugged in or stay active after buttons are released, posing a risk of unintended operation.
The SafeAir Smoke Evacuation Pencils in these kits may activate automatically when plugged into a power source or remain active after being released from a button press. This could lead to unintended operation during medical procedures.
Healthcare professionals using Medline breast biopsy kits with specific model numbers and lot codes. Those handling the kits during procedures are most at risk due to potential unintended activation.
Check for kits labeled as BREAST BIOPSY PACK-LF (REF DYNJ0160598C), BIOPSY BREAST PACK (REF DYNJ65361A), or BREAST BIOPSY/MASTECTOMY (REF DYNJ908839A). Look for specific lot numbers listed in the recall notice.
Identify the model number and lot numbers on the kit to confirm if it is affected.
If the kit matches the recalled model and lot numbers, stop using it immediately to prevent unintended activation.
The SafeAir Smoke Evacuation Pencils in these kits may activate without manual input when plugged in or remain active after button release, which could lead to unintended operation during medical procedures.
Kits labeled as BREAST BIOPSY PACK-LF (REF DYNJ0160598C), BIOPSY BREAST PACK (REF DYNJ65361A), or BREAST BIOPSY/MASTECTOMY (REF DYNJ908839A) with specific lot numbers listed in the recall notice.
Check the model number and lot numbers on the kit. Affected kits include those with model numbers DYNJ0160598C, DYNJ65361A, or DYNJ908839A and specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0515-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-0515-2026 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.
