RegWardenFDA facility compliance records
Recall

Class III — Lighthouse For The Blind

Recalling firmLIGHTHOUSE FOR THE BLIND
Registered facilityLIGHTHOUSE FOR THE BLIND (the firm's only registered facility)
ClassificationClass III
StatusTerminated
ReasonThe 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 applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili
ProductLHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
Quantity227 kits
DistributionNationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY.
Initiated2013-03-22
Classified2013-04-10
Terminated2013-11-25
Recall numberZ-1091-2013
InitiationVoluntary: Firm initiated

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

Cite this record

RegWarden. “Class III recall — Lighthouse For The Blind (Z-1091-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64776/

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