Intersurgical Inc: Medical Device Recall in 2017 - (Recall #: Z-0208-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management.

Product Classification:

Class II

Date Initiated: April 3, 2017

Date Posted: December 13, 2017

Recall Number: Z-0208-2018

Event ID: 76945

Reason for Recall:

A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.

Status: Terminated

Product Quantity: 144 cases / 20 units

Code Information:

Product Lots: 31402822 to 31610791

Distribution Pattern:

Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico

Voluntary or Mandated:

Voluntary: Firm initiated