RegWardenFDA facility compliance records
Company

Hobbs Medical Inc

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

Recalls by year

FDA actions on record by year2018: 1 recalls; 2021: 1 recalls; 2022: 2 recalls; 2024: 1 recalls20171201820192020120212202220231202420252026
  • Recalls (5)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-10-04
    Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
  • Class IIOngoing2022-07-29
    Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits contain…
  • Class IIOngoing2022-06-03
    During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.
  • Class IIOngoing2021-12-28
    The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
  • Class IITerminated2018-05-01
    Device was marketed for uses outside the 510(k) clearance.

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. “Hobbs Medical Inc — 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-1220592-hobbs-medical-inc/

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