Henry Schein recalls blue Level 3 anti-fog earloop masks (item 570-3281) produced on unvalidated equipment. These masks may not meet safety standards due to production issues.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Henry Schein is recalling blue Level :3 anti-fog earloop masks (item code 570-3281) because they were made on equipment that wasn't properly tested. This could mean the masks don't meet safety standards, but the risk isn't described as causing serious injury.
These masks were produced on equipment that wasn't part of the initial safety testing. This means they might not meet the required safety standards, but the recall doesn't specify a risk of injury or serious harm.
People who bought or use Henry Schein's blue Level 3 anti-fog earloop masks (item code 570-3281) are affected. Those in medical or industrial settings using these masks may be at slightly higher risk due to the production issue.
Check for the blue color and item code 570-3281 on the mask packaging. The lot numbers 2340, 2341, and 2342 are also associated with this recall.
Look for the item code 570-3281 and lot numbers 2340, 2341, or 2342 on the mask packaging.
The recall states the masks were produced on unvalidated equipment, but it doesn't say they cause injury or serious harm. They may not meet safety standards.
Check for the blue color, item code 570-3281, and lot numbers 2340, 2341, or 2342 on the packaging.
The recall doesn't specify a need to stop using them immediately; the risk is described as low.
We’ve drafted a message you can send Henry Schein to request your refund or repair — edit it as you like.
Subject: Recall Z-1147-2024 — Henry Schein Henry Schein Hello, I own a Henry Schein that is covered by recall Z-1147-2024 from Henry Schein. 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.