Covidien LLC: Medical Device Recall in 2018 - (Recall #: Z-1130-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 12, 2017

Date Posted: March 28, 2018

Recall Number: Z-1130-2018

Event ID: 79296

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.

Status: Terminated

Product Quantity: 20,800

Code Information:

Lot Number: 170704A UDI: 20884521700861

Distribution Pattern:

U.S.

Voluntary or Mandated:

Voluntary: Firm initiated