Microtek Medical Recalls Freedomaire Surgical Helmet Systems Due to Latex Packaging
Microtek Medical is recalling 10 Freedomaire Surgical Helmet Systems because the packaging contains latex but lacks the required warning label.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling error regarding a known allergen (latex) where no illnesses or injuries are reported, fitting the criteria for a moderate severity recall.
Plain-English summary
Microtek Medical Inc is recalling 10 units of the Freedomaire(R) Helmet System with Super Power Pak Battery, Lumbar Belt and Motor Module (Ref 11110STK). The affected units are identified by lot numbers C10078 and C11056. The product is a non-sterile surgical helmet system intended to be worn by surgical personnel to provide a barrier against contamination, body fluids, and microorganisms.
The recall is being conducted because the cohesive band used to package the devices contains latex. The product is not labeled as required by 21 CFR 801.437, specifically missing the caution statement: "The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
The affected units were distributed nationwide in the United States. Users should stop using the product and contact Microtek Medical Inc for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Microtek Medical Inc
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: C10078 and C11056
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Microtek Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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