Agency classClass IIOur severity:High FDA (Devices)·Z-1346-2015·Announced 2015-04-08

Microtek Medical Smoke Evacuator Tubing Set Recalled for Latex Packaging

Microtek Medical is recalling smoke evacuator tubing sets 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 a known allergen (latex) in the packaging of a medical device. Per the rubric, allergen mislabeling on common allergens is classified as High (Score 3), particularly when the hazard is a risk of harm (allergic reaction) without reported injuries in the source text.

Plain-English summary

Microtek Medical Inc is recalling specific lots of Tubing Set 7/8" x 6' with 1/4" x 24" tubing (Ref 24136). The recall involves 5,889 units that were distributed nationwide in the United States. The affected products are intended to evacuate smoke created by electrosurgery, laser surgery, or power tool surgical procedures in operating rooms, trauma, endoscopy, and laparoscopy sites.

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 contain the required caution statement: "The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."

Healthcare facilities and consumers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations to prevent potential allergic reactions in latex-sensitive individuals.

The recalled product

Product: TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include…
Manufacturer: Microtek Medical Inc
Category: Medical Device — Surgical Accessories
Hazard: latex-allergy
mis-labeling
Affected units: 5,889

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 (20)

Lot Numbers: C9225
C9232
C10239
C10285
C11042
C11129
C11136
C11172
C11209
C11216
C11279
C11300
C11332
C12010
C12023
C12102
C12157
C12194
C12215
C12251

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

See all →

Severe
Microtek Patient Drape Adapter Plug Kits Recalled for Non-Sterile Labeling
FDA (Devices) · 2025-06-18
High
Vial Decanter Medical Device Recalled for Compromised Sterile Packaging
FDA (Devices) · 2024-08-28
High
Transfer Device REF 2008S Sterile Barrier Packaging Defect Recall
FDA (Devices) · 2024-08-28
High
Bottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects
FDA (Devices) · 2024-08-28
Moderate
C-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall
FDA (Devices) · 2024-08-28

Same hazard · latex allergy