Stryker High Flow II Tube Set — Class II medical device recall Z-1726-2019
Terminated recall by Stryker Corporation, reported 2019-06-12, distributed nationwide. The heated tube sets were consistently leaking and detaching from the cassette.
| Recall number | Z-1726-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2019-03-07 |
| Classified | 2019-06-04 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2024-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BR, CA, CL, CO, IN, JP, MX, SA, UY |
| Quantity | 32,537 boxes |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 07613327055634 |
| Lot numbers | 18G0269, 18H0353, 18K0379, 56004320, 56004325, 56004329, 56004356, 56004366, 56004373, 56004384, 56004387, 56004426, 56004432, 56004441, 56004443, 56004451, 56004459, 56004461, 56004487, 56004494, 56004502, 56004508, 56004515, 56004518, 56004528, 56004551, 56004565, 56004573, 56004584, 56004600, 56004614, 56004616, 56004624, 56004628, 56004632, 56004681, 56004686, 56004696, 56004704, 56004719 and 195 more |
| Model numbers | 0620-040-660 |
Product
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Reason for recall
The heated tube sets were consistently leaking and detaching from the cassette.
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-1726-2019. 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.