Mindray A5 Anesthesia Delivery System Manufactured in China for… — Class I medical device recall Z-0291-2013
Terminated recall by Mindray DS USA, Inc. d.b.a. Mindray North America, reported 2012-11-28, distributed nationwide. Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorb
| Recall number | Z-0291-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2012-08-13 |
| Classified | 2012-11-16 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, CO, VE |
| Reason classes | packaging |
| Serial numbers | 0631F-01000-00, EJ-15001187, EJ-1A001411, EJ-1A001412, EJ-1A001413, EJ-1A001414, EJ-1A001415, EJ-1A001416, EJ-1A001417, EJ-1A001418, EJ-1A001419, EJ-1A001420, EJ-1A001421, EJ-1A001422, EJ-1A001423, EJ-1A001424, EJ-1A001425, EJ-1A001426, EJ-1A001428, EJ-1A001429, EJ-1A001430, EJ-1A001431, EJ-1A001433, EJ-1A001434, EJ-1A001435 and 287 more |
Product
Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
Reason for recall
Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.
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-0291-2013. 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.