Microtek Smoke Evacuation Tubing Set Recalled for Latex Packaging Labeling Error
Microtek Medical Inc is recalling 303 Smoke Evacuation 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 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, which typically corresponds to a moderate severity score. The hazard involves a labeling error regarding latex content, which is a known allergen, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Microtek Medical Inc is recalling 303 units of Smoke Evacuation Tubing Sets for Coherent CPG Handpiece, Reference 24244. The affected units were distributed nationwide in the United States. The recall involves specific lot numbers, including C11020, C11129, and C11238, among others.
The recall is being conducted because a 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 affected lot numbers. If the product is found, it should be removed from use and returned to Microtek Medical Inc or the distributor.
The recalled product
- Product
- Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, 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…
- Manufacturer
- Microtek Medical Inc
- Affected units
- 303
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: C11020
- C11129
- C11238
- C11276
- C12013
- C12044
- C12079
- C12094
- C12108
- C12124
- C12212
- C12236
- C12243
- C12254
- C12271
- C12334
- C13031
- C13070
- C13080
- C13162
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 →Related recalls
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