Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY Recalled by Microtek Medical Inc Due to This recall is being conducted because a cohesive...
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 Microtek Medical Inc directly.
Affected Products
FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
Quantity: 10 units
Why Was This Recalled?
This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Microtek Medical Inc
Microtek Medical Inc has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report