Microtek Medical Inc: Medical Device Recall in 2015 - (Recall #: Z-1338-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 fluids and microorganisms.

Product Classification:

Class II

Date Initiated: March 10, 2015

Date Posted: April 8, 2015

Recall Number: Z-1338-2015

Event ID: 70721

Reason for Recall:

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.

Status: Terminated

Product Quantity: 38 units

Code Information:

Lot Numbers: C11049, C11076, C12339, C13063, C13091, C13109, C13218, C13364

Distribution Pattern:

US (nationwide) Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated