Hudson RCI — Class II medical device recall Z-2108-2014
Terminated recall by Teleflex Medical, reported 2014-07-30, distributed in CA, FL, KS, KY, MA, MI, MO, NC…. The temperature probe does not properly connect to the temperature port.
| Recall number | Z-2108-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Durham, NC, United States |
| Recall initiated | 2014-07-09 |
| Classified | 2014-07-23 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2017-03-09 |
| Distributed | CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX, VA |
| Countries outside the US | AR, CL, CO, PH |
| Quantity | 11,679 units |
| Lot numbers | 02A1400518, 02A1401286, 02A1402358, 02B1400178, 02B1400715, 02B1401320, 02K1301986, 02L1300010, 02L1300037, 02L1301081, 02L1301783, 02M1300190, 02M1300236 |
| Model numbers | 1696 |
Product
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.
Reason for recall
The temperature probe does not properly connect to the temperature port.
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-2108-2014. 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.