Agency classClass IIOur severity:High FDA (Devices)·Z-1338-2015·Announced 2015-04-08

Microtek Medical Recalls Surgical Helmet Motor Modules for Latex Packaging

Microtek Medical Inc is recalling 38 units of FREEDOMAIRE Motor Modules 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves allergen mislabeling (latex) on a medical device, which fits the High severity criteria for common allergens without reported illness.

Plain-English summary

Microtek Medical Inc is recalling 38 units of the FREEDOMAIRE(R) Motor Module, Reference 11112STK. The product is a non-sterile, latex-free surgical helmet system intended to provide a barrier between surgical personnel and the operating environment.

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 and does not include the caution statement: "The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."

The affected units are distributed nationwide in the US. The specific lot numbers involved are C11049, C11076, C12339, C13063, C13091, C13109, C13218, and C13364. Users should check their inventory for these lot numbers and stop using the product if the packaging band is present.

The recalled product

Product: FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, 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…
Manufacturer: Microtek Medical Inc
Category: Medical Device — Surgical Equipment
Hazard: latex-allergy
mis-labeling
Affected units: 38

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 (8)

Lot Numbers: C11049
C11076
C12339
C13063
C13091
C13109
C13218
C13364

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