Situate Gauze RF and X-Ray detectable — Class II medical device recall Z-1130-2018
Terminated recall by Covidien LLC, reported 2018-03-28. This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauz
| Recall number | Z-1130-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2017-10-12 |
| Classified | 2018-03-19 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2020-05-12 |
| Quantity | 20,800 |
| UPC / GTIN / UDI-DI | 20884521700861 |
| Lot numbers | 170704A |
Product
Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the green pouch that you will see on all Situate premium cotton. When activated by magnetic impulses from the scanning devices, the tag resonates a signal that allows for the detection of these cotton disposable.
Reason for recall
This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error.
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-1130-2018. 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.