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
Intersurgical is recalling size 3 laryngeal mask airways that have been incorrectly marked with size 4 information. This could pose health risks to patients during medical procedures if the wrong size is used.
The size 3 airway has been incorrectly marked with size 4 information, including the number 4 as a size identifier, patient weight, and maximum inflation volume. This could lead to using the wrong size airway during medical procedures, potentially causing health risks.
Healthcare professionals using the Solus Standard laryngeal mask airways for patients weighing 30-50kg are most at risk. Patients receiving these airways during medical procedures may be affected.
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.
Look for incorrect size 4 markings on the airway tube and inflation line pilot balloon.
The product has been incorrectly marked with size 4 information, which could pose health risks if used incorrectly. Do not use until verified.
Check for model number 8003000 and lot code 32204071 on the Solus Standard laryngeal mask airway for small adult patients (30-50kg).
The recall does not specify a remedy, so check device markings and contact Intersurgical for guidance.
We’ve drafted a message you can send Intersurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0096-2023 — Intersurgical Intersurgical Hello, I own a Intersurgical that is covered by recall Z-0096-2023 from Intersurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.