LMA Esophageal Intubation Detector Recalled for Potential False Positive Readings
LMA North America Inc is recalling 18,799 units of the LMA Esophageal Intubation Detector (EID100) because the device may produce false positive results during intubation confirmation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential false positive in a medical device used for critical airway management, which poses a risk of harm if clinical judgment is compromised, but no specific injuries or fatalities are reported in the source text.
Plain-English summary
LMA North America Inc is recalling 18,799 units of the LMA Esophageal Intubation Detector (EID100), Catalog Number EID100. The device is used to assist in verifying the placement of endotracheal tubes or esophageal/tracheal double lumen tubes as an adjunct to clinical judgment.
The recall was initiated after the manufacturer received a complaint indicating that the EID100 has the potential to create a false positive if used on a patient during the confirmation of intubation. The affected units were distributed nationwide in the United States, as well as in Canada, the United Kingdom, South Africa, and Australia. Specific lot numbers affected include those from 2009, 2010, 2011, and 2012.
Healthcare facilities and users should stop using the affected devices and contact LMA North America Inc for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- 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 elimina
- Manufacturer
- LMA North America Inc
- Affected units
- 18,799
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 2009 Lot # 90923A
- 91222A. 2010 Lot# 00327A
- 00518A
- 00623A
- 00831B
- 01013A
- 01103A
- 01214A. 2011 Lot# 10110A
- 10301B
- 10423A
- 10530A
- 10602A
- 10703A
- 10804A
- 11004A. 2012 Lot# 120104
- 120414.
Distribution
Distributed nationwide across the United States.
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