RegWardenFDA facility compliance records
Company

Summit Medical, LLC

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2015: 1 recalls; 2023: 1 recalls1’131’141’15’16’17’18’19’20’21’221’23’24’25’26
  • Recalls (4)

Registered facilities (1)

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).

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. “Summit Medical, 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-10033920-summit-medical-llc/

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