RegWardenFDA facility compliance records
Facility

Skytron, LLC

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

Activity by year

FDA actions on record by year2023: 1 recalls; 2026: 1 warning letters201720182019202020212022120232024202512026
  • Recalls (1)
  • Warning letters (1)

Devices registered here (1)

  • Apparatus, Exhaust, Surgical
    Product code FYD (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.5070

Recalls & enforcement

  • Class IIOngoing2023-08-01
    When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and t…

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

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. “Skytron, LLC (FEI 1825014) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1825014-skytron-llc/

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