Can block a launchUnited StatesHealth & medical products

9% of US medical device recalls are Class I

9% of United States medical device recalls are Class I, the class FDA uses when there is a reasonable probability that the product causes serious harm or death: 3,617 of 39,634 classified enforcement records since 2012.

Class share tracks how bad the failures are, where a raw recall count mostly tracks how hard anyone looked.

80 of a possible 90Tier B, systematic first-party observation. Nothing at this tier is allowed past 90, however good it looks.

Verified September 9, 2026Rechecked every 180 days, next by March 8, 2027.

Outcome

Held since January 1, 2012What repeatedly happened when brands acted. The earliest date we are willing to say this held. It may well have been true before that; we do not backdate a record past the evidence we have read. Supported, version 1.

This entry is wrong if

Recomputing the Class I share over openFDA’s medical device enforcement endpoint returns a value outside 4% to 14%.

Written before the record was published, not after. If you can show this, send it to hello@tryorbt.com and the correction goes on the record with the entry.

Evidence

Tier Bregulationn = 3617
US Food and Drug Administration: openFDA enforcement reports (food, drug, device)
3,617 Class I medical device enforcement records, counted in the register on 2026-09-09.
Read 2026-09-09 · Public domain

History

v1createdAugust 10, 2026
Derived from the us-recall-severity family on 2026-08-10.

Append-only. Nothing in this list is edited or removed once written, including the entries that record our own mistakes. Every change to every record is on the corrections page, and the same log is in entries.json under revisions.

Cite this entry

“9% of US medical device recalls are Class I”, The Orbt Market Index 0.1.0, entry omr:us:device:recall-severity, retrieved September 9, 2026, https://tryorbt.com/markets/entry/us--device--recall-severity. Dataset: https://doi.org/10.5281/zenodo.22679129

Orbt, "9% of US medical device recalls are Class I," Orbt Market Index, entry omr:us:device:recall-severity, verified September 9, 2026, https://tryorbt.com/markets/entry/us--device--recall-severity.

@misc{orbt-us-device-recall-severity,
  title        = {9% of US medical device recalls are Class I},
  author       = {{Orbt}},
  year         = {2026},
  doi          = {10.5281/zenodo.22679129},
  note         = {The Orbt Market Index 0.1.0 (dataset DOI 10.5281/zenodo.22679129), entry omr:us:device:recall-severity. Verified 2026-09-09},
  howpublished = {\url{https://tryorbt.com/markets/entry/us--device--recall-severity}},
  license      = {Orbt Index Public Licence. Free to quote and cite; not to redistribute}
}

For a deck, a brief or a chat.

Free to quote, cite and act on. Not to resell or redistribute — the sources ask that of us, and each one’s terms are named. Machine-readable: entries.json carries this record under the id omr:us:device:recall-severity, with the same evidence and falsifier.

Published free, as reference, without warranty. This is not legal, regulatory, customs, tax or investment advice, and it is not a substitute for reading the primary document, which every record here names, dates and links, precisely so that you can.

We derive from public sources and we do not independently audit them. Where a source says its own records are unverified, that carries through to us. What we do promise is that every figure is recomputed from stored rows, every claim publishes the observation that would overturn it, and every correction goes on the public log. If something here is wrong, tell us and it changes in the open.

Orbt is not affiliated with, endorsed by or acting for US Food and Drug Administration. They are cited as sources. Go and read them directly — they are more complete than we are, and they are linked from every record that rests on them.

This entry is wrong if

Evidence

History

Cite this entry

Read next