Microtek Medical Recalls Laparoscopic Tubing Sets Due to Unlabeled Latex Packaging
Microtek Medical Inc. is recalling 270 units of sterile laparoscopic 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 allergen mislabeling (latex) on a medical device, which fits the rubric criterion for 'Allergen mislabeling on common allergens' or 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Microtek Medical Inc. is recalling 270 units of sterile Laparoscopic Tubing Sets, Reference 24311. The affected lots are C10104, C10272, C11080, and C14052. These devices were distributed nationwide in the United States.
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 include the required caution statement: "The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."
The intended use of these smoke evacuator accessories is to evacuate smoke created by electrosurgery, laser surgery, or power tool surgical procedures in operating rooms, trauma, endoscopy, and laparoscopy sites. Users should check their inventory for the specific lot numbers listed above and contact the manufacturer for further instructions.
The recalled product
- Product
- LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/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…
- Manufacturer
- Microtek Medical Inc
- Affected units
- 270
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 (4)
- Lot Numbers: C10104
- C10272
- C11080
- C14052
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
- HighVial Decanter Medical Device Recalled for Compromised Sterile Packaging
FDA (Devices) · 2024-08-28
- HighTransfer Device REF 2008S Sterile Barrier Packaging Defect Recall
FDA (Devices) · 2024-08-28
- HighBottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects
FDA (Devices) · 2024-08-28
- ModerateC-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall
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
Similar recalls
- HighEcolab Recalls Microtek Medical Bur Hole Latex Probe Covers
FDA (Devices) · 2014-02-19
- ModerateEcolab Recalls Microtek Medical Bur Hole Probe Covers for Testing Defects
FDA (Devices) · 2014-02-19
- HighAlcon Custom Pak surgical packs mislabeled as latex-free despite containing latex
FDA (Devices) · 2025-03-12
- HighEcolab Recalls Microtek Medical Bur Hole Probe Covers for Endotoxin Testing
FDA (Devices) · 2014-02-19
- ModerateCook Medical Recalls LapSac Introducer Sets Due to Insufficient Reprocessing Instructions
FDA (Devices) · 2017-06-14
- HighAlcon Custom Pak 9319-27 Recalled for Latex Glove Mislabeling
FDA (Devices) · 2015-11-11