CLASS II Device recall · Reported 26 Oct 2022 · FDA Enforcement Report

Solus Standard, laryngeal mask airway, size 3, small adult recalled

Intersurgical is recalling Solus Standard, laryngeal mask airway, size 3, small adult, 30, distributed in Ohio, Tennessee, Texas. The recall was initiated on 29 Aug 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071

Quantity recalled340 pieces

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0096-2023
FDA event ID: 90855
Recalling firm: Intersurgical, East Syracuse, NY
Classification: Class II
Status: Terminated
Recall initiated: 29 Aug 2022
FDA classified: 17 Oct 2022
Reported: 26 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

29 Aug 2022	Recall initiated by company
17 Oct 2022	Classified by FDA	+49 days
26 Oct 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

OH, TN, TX

Ohio Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

OH, TN, TX

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Intersurgical

All 13

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	One-Piece Guedel Airway, size 00, ISO 5.0, Blue recalled	Intersurgical	Other	Nationwide
26 Aug 2026Device	CLASS II	One-Piece Guedel Airway, size 000, ISO 3.5, Light Green recalled	Intersurgical	Other	Nationwide
13 Aug 2025Device	CLASS II	One-piece Guedel airway, size 3, ISO 9.0, yellow recalled	Intersurgical	Other	10 states
13 Aug 2025Device	CLASS II	One-piece Guedel airway, size 2, ISO 8.0, green recalled	Intersurgical	Other	10 states
23 Jul 2025Device	CLASS I	i-view video laryngoscope recalled by Intersurgical	Intersurgical	Other	17 states

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