RegWardenFDA facility compliance records
Facility

SUMMIT MEDICAL 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; 2015: 1 recalls; 2016: 1 inspections; 2018: 2 inspections; 2023: 1 recalls1’131’141’151’16’172’18’19’20’21’221’23’24’25’26
  • Recalls (4)
  • Inspections (3)

Devices registered here (1)

  • Instrument, Surgical, Disposable
    Product code KDC (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

  • Class IITerminated2023-01-13
    Sterile product pouches were not sealed.
  • Class IITerminated2015-09-03
    Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does not have the split in the packing.
  • Class IITerminated2014-05-12
    One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.
  • Class IITerminated2013-03-27
    Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile).

FDA inspections (3)

  • VAI2018-05-14
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2018-03-09
    Voluntary Action Indicated · Compliance: Devices; Project Evaluation: Devices · citations posted
  • VAI2016-11-10
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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. “SUMMIT MEDICAL LLC (FEI 3008719017) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008719017-summit-medical-llc/

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