BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are… — Class II medical device recall Z-0565-2013
Terminated recall by Del Mar Reynolds Medical, Ltd., reported 2012-12-26, distributed nationwide. The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe
| Recall number | Z-0565-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Del Mar Reynolds Medical, Ltd., Hertford, United Kingdom |
| Recall initiated | 2012-11-02 |
| Classified | 2012-12-19 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BD, BH, BO, CL, CN, DO, DZ, EC, EG, ES, FI, GH, GT, HK, HN, ID, IN, IQ, JM, JO, LB, LK, MX, MY, NG, NI, NL, NP, NZ, PE, PH, PK, PT, PY, SA, SG, TH, TR, TT, TW, UY, VE, VN, ZA |
Product
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
Reason for recall
The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.
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-0565-2013. 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.