Lower riskMedical device recall · FDA · Published August 29, 2022
Intersurgical Solus Standard Laryngeal Mask Airway Size 3 Recall: Incorrect Size Marking
Intersurgical recalls size 3 laryngeal mask airways with incorrect size 4 markings that may pose health risks. Affected units have model number 8003000 and lot code 32204071.
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
Take action
Contact the company
📍Recalling firmIntersurgical Inc6757 Kinne St · East Syracuse, NY 13057-1215
“Intersurgical Solus Standard Laryngeal Mask Airway Size 3 Recall: Incorrect Size Marking.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60117-intersurgical-solus-standard-laryngeal-mask-airway-size-3-recall-incorrect. Based on FDA recall #Z-0096-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0096-2023%22&limit=1).
Intersurgical Inc recalled Intersurgical Solus Standard laryngeal mask airways due to a printing error posing a health risk, according to the FDA. The Food and Drug Administration announced the recall on Aug. 29, 2022.
How to tell if you have it
Brand: Intersurgical
Product: Solus Standard laryngeal mask airway, size 3, small adult, 30-50kg
Model Number: 8003000
UDI-DI (Single unit): 5030267073511
UDI-DI (Case): 05030267046959
Lot code: 32204071
Quantity: 340 pieces
Distribution: OH, TN, TX
The hazard
The device has been incorrectly marked with size 4 information, including 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. This printing error may pose a health risk to the patient.
Context
GovInfoNow's records show Intersurgical Inc has 6 other recalls on record since April 25, 2018. Other recent recalls of similar products include Medline Intubation Tray Recall (Dec. 24, 2025), Medline 14 Fr Suction Catheter Kits Recall (Dec. 24, 2025) and DeRoyal Myocardial Probe Recall (Aug. 20, 2026).
How to tell if you have this one
Check for model number 8003000 on the Solus Standard laryngeal mask airway. Units sold with lot code 32204071 are affected. The device is intended for small adult patients weighing 30-50kg.
Brand
Intersurgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Markings
Look for incorrect size 4 markings on the airway tube and inflation line pilot balloon.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “OH, TN, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio, Tennessee, Texas.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0096-2023 (August 29, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0096-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.