Henry Schein recalls Level 3 blue earloop masks (item 570-2448) 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 earloop masks (item code 570-2448) because they were made on equipment not properly tested for safety. This could mean the masks don't meet required safety standards.
The masks were produced on equipment that wasn't validated during initial testing. This means they might not meet the safety standards required for medical use, but the risk is not severe enough to cause serious injury.
Users of these specific blue earloop masks for medical or dental use. Healthcare professionals and others who purchased the masks from authorized retailers are most at risk.
Check for the blue color, item code 570-2448, and lot numbers 2337-2344. These masks were sold by Henry Schein through authorized retailers.
Look for the item code 570-2448 and lot numbers 2337, 2338, 2342, 2343, or 2344 on the mask packaging.
The recall states these masks were produced on unvalidated equipment, but the official notice doesn't specify if they are unsafe. They may not meet safety standards.
Check for the blue color, item code 570-2448, and lot numbers 2337, 2338, 2342, 2343, or 2344.
The recall doesn't specify a remedy, so the official notice doesn't say what to do with them.
We’ve drafted a message you can send Henry Schein to request your refund or repair — edit it as you like.
Subject: Recall Z-1146-2024 — Henry Schein Henry Schein Hello, I own a Henry Schein that is covered by recall Z-1146-2024 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.
