Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. Recalled by American Optisurgical Inc Due to American Optisurgical, Inc initiated a recall of ChloraPrep...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact American Optisurgical Inc directly.
Affected Products
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Quantity: 63 individual applicators
Why Was This Recalled?
American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Optisurgical Inc
American Optisurgical Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report