RegWardenFDA facility compliance records
Facility

LIGHTHOUSE FOR THE BLIND

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2018: 1 inspections1’13’14’15’16’171’18’19’20’21’22’23’24’25’26
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Dressing, Wound, Occlusive
    Product code NAD (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4020

Recalls & enforcement

  • Class IIITerminated2013-03-22
    The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicabl…

FDA inspections (1)

  • NAI2018-06-13
    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. “LIGHTHOUSE FOR THE BLIND (FEI 1000118065) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000118065-lighthouse-for-the-blind/

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