Z-1130-2018Class II

Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use...

Name: Z-1130-2018 Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use...
Creator: Covidien LLC
Published: 2017-10-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-10-12 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of 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... on 2017-10-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1130-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-12
Posted: 2018-03-19
Terminated: 2020-05-12
Recalling firm: Medtronic, Inc.
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.
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: All consignees were notified via FedEx or certified mail on October 12, 2017 and the letter 'Urgent Field Corrective action Notice' informs customers of the potential for failure to detect the affected Situate" gauze RF and X-Ray detectable products by the Situate" detection console and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Correction Action Notice. For further questions, please call (203) 492-5000.
Quantity in commerce: 20,800
Distribution: U.S.
Product codes and lots: Lot Number: 170704A UDI: 20884521700861

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1130-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1130-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19

Product code GDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)