Intersurgical Inc: Medical Device Recall in 2022 - (Recall #: Z-0096-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 29, 2022

Date Posted: October 26, 2022

Recall Number: Z-0096-2023

Event ID: 90855

Reason for Recall:

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

Status: Terminated

Product Quantity: 340 pieces

Code Information:

UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071

Distribution Pattern:

OH, TN, TX

Voluntary or Mandated:

Voluntary: Firm initiated