Insufflator — Class II medical device recall Z-0866-2017
Terminated recall by Northgate Technologies, Inc., reported 2016-12-28, distributed in FL, MA. Device could cause a patient overpressure situation without any visual or auditory indication or warning
| Recall number | Z-0866-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northgate Technologies, Inc., Elgin, IL, United States |
| Recall initiated | 2016-11-21 |
| Classified | 2016-12-21 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-11-27 |
| Distributed | FL, MA |
| Countries outside the US | CA |
| Quantity | 49 devices |
| Serial numbers | 89170HXB, 89556DYD, 89652FYA, 89661FYA, 89663FYA, 89664FYA, 89670FYA, 89672FYA, 89675FYA, 89677FYA, 89685FYB, 89697FYB, 89708GYA, 89713GYA, 89719GYB, 89720GYB, 89729GYB, 89732GYB, 89734GYB, 89737GYB, 89889IYD, 90165AZB, 90285BZD, 90387DZB, 90391DZB and 27 more |
Product
Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures
Reason for recall
Device could cause a patient overpressure situation without any visual or auditory indication or warning
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-0866-2017. 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.