Medline recalls dental packs with breather pouch lot 323080002 that may allow non-sterile product use if pouch seal is opened. Affected kits could pose infection risks during medical procedures.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Medline is recalling dental packs with breather pouch lot 323080002 because opening the pouch seal might let non-sterile products be used. This could lead to infection risks during dental procedures if the seal is broken.
The breather pouch seal may open unintentionally, allowing non-sterile products to be used. This could happen if the pouch seal is broken during handling, potentially leading to infection risks during dental procedures.
Dental professionals and patients using Medline dental packs with breather pouch lot 323080002 are affected. Those handling the pouch seal during procedures face the highest risk.
Check for breather pouch lot number 323080002 on Medline dental packs. The product is a dental procedure convenience kit with UDI/DI numbers 40195327120420 (each) and 10195327120429 (case).
Inspect the breather pouch seal for any signs of opening or damage before use.
The recall indicates a potential risk of using non-sterile products if the pouch seal is opened, but it does not specify serious injury or death. The risk level is low.
Look for breather pouch lot number 323080002 on Medline dental packs with UDI/DI numbers 40195327120420 (each) or 10195327120429 (case).
Check the pouch seal for damage before use. If the seal is broken, do not use the product and contact Medline for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0159-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-0159-2025 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.