Mindray DS USA Inc — Class II medical device recall Z-2549-2016
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2016-08-24, distributed nationwide. Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Pas
| Recall number | Z-2549-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2016-06-23 |
| Classified | 2016-08-16 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2017-03-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 360 units |
| Reason classes | packaging |
| Lot numbers | 1534, 1537, 1538, 1541, 1545, 1547, 1548, 1602, 1606 |
Product
Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.
Reason for recall
Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.
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-2549-2016. 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.