FDA (Devices) recall action 84118
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.
The agency’s own wording, quoted from the enforcement report.
AMD Medicom Inc. is recalling Level 2 masks that may have been packed in Level 3 boxes, creating a risk of using lower-protection masks.
AMD Medicom is recalling Level 3 masks because Level 2 masks may have been packed in Level 3 boxes. The masks are visually indistinguishable, creating a risk of using lower protection.