Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for… — Class II medical device recall Z-2093-2017
Terminated recall by Del Mar Reynolds Medical, Ltd., reported 2017-05-24, distributed in FL, LA, MS, NC, SC, WY. Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causi
| Recall number | Z-2093-2017 |
|---|---|
| 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 | 2017-04-14 |
| Classified | 2017-05-16 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2017-10-16 |
| Distributed | FL, LA, MS, NC, SC, WY |
| Countries outside the US | GB, PA |
| Reason classes | packaging |
| Serial numbers | ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, ARKN-000413 |
| Model numbers | 050-9045-00, 380-0916-01, 650-1648-01 |
Product
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.
Reason for recall
Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.
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-2093-2017. 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.