Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Intersurgical Solus Standard Recalled by Intersurgical Inc Due to Printing error on the device, size 3 Solus...

Date: August 29, 2022
Company: Intersurgical Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Intersurgical Inc directly.

Affected Products

Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

Quantity: 340 pieces

Why Was This Recalled?

Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient

Where Was This Sold?

This product was distributed to 3 states: OH, TN, TX

Affected (3 states)Not affected

About Intersurgical Inc

Intersurgical Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report