Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1340-2015·Announced 2015-04-08

Microtek Medical Recalls Freedomaire Surgical Helmets Due to Latex Packaging

Microtek Medical Inc is recalling 11 units of 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: The recall is classified as FDA Class II and involves a labeling error regarding a known allergen (latex). No illnesses or injuries are reported in the source text, and the hazard is theoretical for those without latex allergies, fitting the Moderate criteria for minor labeling errors or low-risk contamination.

Plain-English summary

Microtek Medical Inc is recalling 11 units of the Freedomaire(R) Helmet System with Belt, Reference 11114STK. The affected products are non-sterile surgical helmets intended to be worn by surgical personnel to provide a barrier against contamination, body fluids, and microorganisms. The recall covers lot numbers C9272 and C10078, which were distributed nationwide in the United States.

The recall is being conducted because the cohesive band used to package the devices contains latex, but the product is not labeled as required by 21 CFR 801.437. Specifically, the packaging does not include the required caution statement: "The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."

This recall is classified as Class II by the FDA. Individuals with a known latex allergy should avoid using these products. Users should check their inventory for the specific lot numbers listed above and contact the manufacturer for further instructions.

The recalled product

Product: FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, 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…
Manufacturer: Microtek Medical Inc
Category: Medical Device — Surgical Protective Equipment
Hazard: latex-allergy
mis-labeling
Affected units: 11

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: C9272 and C10078

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.

See all 13 products in this recall →

Same manufacturer · Microtek Medical Inc

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Same hazard · latex allergy