LMA Esophageal Intubation Detector — Class II medical device recall Z-2022-2012
Terminated recall by LMA North America Inc, reported 2012-07-25, distributed nationwide. The recall was initiated because LMANA has received a complaint that the Esophageal Intubation Detector (EID10
| Recall number | Z-2022-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LMA North America Inc, San Diego, CA, United States |
| Recall initiated | 2012-05-23 |
| Classified | 2012-07-17 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2012-12-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB |
| Quantity | 18,799 units |
| Lot numbers | 00327A, 00518A, 00623A, 00831B, 01013A, 01103A, 01214A, 10110A, 10301B, 10423A, 10530A, 10602A, 10703A, 10804A, 11004A, 120104, 120414, 2010, 2011, 2012, 90923A, 91222A |
| Model numbers | EID100 |
Product
LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment
Reason for recall
The recall was initiated because LMANA has received a complaint that the Esophageal Intubation Detector (EID100) has a potential to create a false positive if used on a patient during confirmation of intubation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2022-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.