RegWardenFDA facility compliance records
Facility

CENORIN, LLC

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2017: 1 recalls; 2018: 1 recalls; 2020: 1 inspections1’131’14’15’161’171’18’191’20’21’22’23’24’25’26
  • Recalls (4)
  • Inspections (1)

Devices registered here (1)

  • Device, Pasteurization, Hot Water
    Product code LDS (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6991

Recalls & enforcement

  • Class IITerminated2018-04-09
    There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
  • Class IITerminated2017-06-07
    Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
  • Class IITerminated2014-04-24
    Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.
  • Class IITerminated2013-01-24
    The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.

FDA inspections (1)

  • NAI2020-02-14
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CENORIN, LLC (FEI 3004153171) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004153171-cenorin-llc/

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