Microtek Medical Recalls Sterile Vacuum Tubing Due to Unlabeled Latex Packaging
Microtek Medical Inc is recalling sterile vacuum tubing because the packaging contains latex but lacks the required warning label.
What this means for you
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. The hazard is a labeling error regarding a known allergen (latex) in the packaging, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Microtek Medical Inc is recalling 56,904 units of sterile vacuum tubing (Ref 24010) with tubing extenders. The product is 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 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."
The affected units were distributed nationwide in the United States. The recall involves specific lot numbers, including C10147, C10166, and C10169, among others. Users should check their inventory for the affected lot numbers and contact Microtek Medical Inc for instructions on returning the product.
The recalled product
- Product
- VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locati
- Manufacturer
- Microtek Medical Inc
- Affected units
- 56,904
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: C10147
- C10166
- C10169
- C10174
- C10196
- C10201
- C10207
- C10210
- C10236
- C10298
- C11067
- C11089
- C11108
- C11194
- C11208
- C11238
- C11271
- C11311
- C11362
- C12009
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
Same manufacturer · Microtek Medical Inc
See all →- SevereMicrotek Patient Drape Adapter Plug Kits Recalled for Non-Sterile Labeling
FDA (Devices) · 2025-06-18
- ModerateC-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall
FDA (Devices) · 2024-08-28
- HighTransfer Device REF 2008S Sterile Barrier Packaging Defect Recall
FDA (Devices) · 2024-08-28
- HighVial Decanter Medical Device Recalled for Compromised Sterile Packaging
FDA (Devices) · 2024-08-28
- HighBag Decanter II Medical Device Recalled for Sterile Packaging Defects
FDA (Devices) · 2024-08-28
Same hazard · latex allergy
See all →- ModerateDJO Nylatex Wraps Recalled for Missing Latex Warning Labels
FDA (Devices) · 2020-07-22
- HighCustom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex
FDA (Devices) · 2020-02-05
- ModerateMerit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error
FDA (Devices) · 2019-10-09
- HighCardinal Health Recalls ChemoPlus Chemo Spill Kits Due to Latex
FDA (Devices) · 2019-05-15
- HighCardinal Health Recalls ChemoPlus Goggles Due to Latex Mislabeling
FDA (Devices) · 2019-05-15