BioPro recalls 10179-10196 Endo Head devices due to potential packaging defects that could compromise sterile barrier, risking infection if implanted.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
BioPro is recalling several models of Endo Head devices because their packaging might not keep them sterile. If these devices are implanted, there's a risk of infection.
The packaging could have a defect that compromises the sterile barrier. If the device is implanted into the body, this might lead to infection due to loss of sterility.
Patients who have received the recalled Endo Head devices for medical procedures are most at risk. Healthcare providers using these devices for surgeries may also be affected.
Check for product numbers 10179 through 10196 on the Endo Head devices. All lots and serial numbers are affected.
Look for product numbers 10179 through 10196 on the Endo Head device packaging.
The recall is for potential packaging defects that could compromise sterility, but the risk of infection is only if the device is implanted. Not all users are at risk.
Check the product number on the device packaging; affected models are 10179 through 10196.
The recall does not specify a remedy, so no action is required unless the device is implanted.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0149-2026 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0149-2026 from BioPro. 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.
