LHB — Class III medical device recall Z-1091-2013
Terminated recall by Lighthouse For The Blind, reported 2013-04-17, distributed nationwide. The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's dis
| Recall number | Z-1091-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lighthouse For The Blind, Olivette, MO, United States |
| Recall initiated | 2013-03-22 |
| Classified | 2013-04-10 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2013-11-25 |
| Distributed | Nationwide (US) |
| Quantity | 227 kits |
| Reason classes | labeling, sterility |
Product
LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
Reason for recall
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 applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1091-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.