Label and identifier mismatch on a nasal mask (Z-2740-2026) — 1,133 days from recall start to publication
A recall began for a nasal interface used in sleep therapy because packaging and labeling disagreed about size identification and the associated unique device identifier. The recall started in June 2023; this record was published in July 2026. The two dates point to different things.
Recall overview (primary data)
- ClassificationClass II
- Product typeMedical Device
- Recalling firm3B Medical, Inc.
- ReasonPackaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
- DistributionUS Nationwide distribution.
- Recall initiated2023-06-15
Key points
- Packaging and labeling disagreed about size identification and the associated unique device identifier (UDI/GTIN).
- Nothing is described as broken; what fails to agree is the information identifying which product is which.
- The recall began on 15 June 2023 and was published on 22 July 2026, an interval of 1,133 days.
- The median interval among the 1,408 records this site holds as of 2026-09-04 is 44 days, the top tenth 79, and only 16 (1.1%) reach 365 days.
- Ordering by publication date brings recalls begun years earlier into view as recent ones, so trend arguments must state which date they use.
1Size marking and identifier do not agree
The part that rests against the nose comes in small, medium and large, and the wrong size lets air escape and weakens the therapy. The stated reason is that size identification in the packaging and labeling disagreed with the associated unique device identifier.
That identifier is the number used in distribution, in stock control and in matching products at a hospital; when it does not line up, someone can reach for what they believe is the right product and hold something else. Nothing about the product is broken. What does not agree is the information saying which is which.
2Start and publication are different dates
- 1Recall beginsThe firm starts recalling the affected product (here, 15 June 2023)
- 2NotificationThe firm reports the situation to the FDA
- 3ClassificationThe FDA assigns a class based on its estimate of potential harm
- 4PublicationThe record becomes public as recall information (here, 22 July 2026)
Procedure sits between the two dates, so an interval always exists. In this record it runs to 1,133 days, about three years and one month. The recall had been under way for three years; what happened this year was its publication in this form. The day a record is found and the day action began are entirely different things.
3How the intervals are distributed
The median is 44 days, and even the top tenth sits at 79. At 1,133 days this is clearly an outlier, though the longest runs to 5,616 days, over fifteen years. No reason for a long interval is recorded. Time spent establishing the scope of a recall and time spent in reporting and classification both collapse into the same single number.
4Which moment are you looking at
Sort public data newest first and you are sorting by publication date, which mixes in a recall that began 1,133 days ago. You can be looking at recent recalls and reading an event from several years back. Any argument about trends over time needs to state which date the ordering uses. The listings on this site are ordered by publication date.
Why it matters
Recall records carry two dates, the start and the publication, separated by a median of 44 days and sometimes by more than three years. A list ordered by publication date mixes recalls begun years ago among the newest entries. Any analysis over time, or any claim about recent trends, has to say which date it is built on or it will not match reality.
FAQ
Why did three years pass before publication?
Why does a labeling mismatch matter?
Which date orders the listings?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2740-2026