FDA Device recall Z-0096-2023
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
- FDA Device
- Class II
- terminated
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000 by Intersurgical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0096-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-29 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Intersurgical |
| Distribution | OH, TN, TX |
Product
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Reason
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
Identifiers
| code_info | UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0096-2023%22
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