# FDA recall Z-1130-2018

> **Covidien LLC** · Class II · device recall initiated 2017-10-12.

## 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.

## Distribution

U.S.

## Key facts

- **Recall number:** Z-1130-2018
- **Recalling firm:** Covidien LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-12
- **Report date:** 2018-03-28
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1130-2018

## Citation

> AI Analytics. FDA recall Z-1130-2018. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1130-2018. Source: US FDA. Licensed CC0.

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