RegWardenFDA facility compliance records
Company

CellEra, LLC

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2016: 1 recalls; 2021: 1 recalls1201620172018201920201202120222023202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIITerminated2021-12-15
    Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
  • Class IITerminated2016-09-01
    Adhesive border was not sticky enough.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “CellEra, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10029252-cellera-llc/

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