PneumoSure XL High Flow Insufflator and PneumoSure High Flow… — Class II medical device recall Z-1566-2016
Terminated recall by Stryker Endoscopy, reported 2016-05-04, distributed nationwide. When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, wit
| Recall number | Z-1566-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Endoscopy, San Jose, CA, United States |
| Recall initiated | 2016-03-28 |
| Classified | 2016-04-25 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2016-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CL, CN, GT, HK, IN, JP, KR, MX, NL, PE, PL, RO, SG, TW, VN, ZA |
| Quantity | 489 |
| Lot numbers | 0005051337-000505052795 |
| Serial numbers | 1510CE0342-1601CE0581 |
| Model numbers | 105-210-684, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 620-040-610, 620-040-611, 620-040-613, 620-040-614 |
Product
PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.
Reason for recall
When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.
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-1566-2016. 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.