Situate recallZ-1130-2018 · Covidien LLC · initiated Oct 12, 2017
Class II Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1130-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 12, 2017
- Recalling firm
- Covidien LLC
- Quantity
- 20,800
- Product code
- GDY
- Distribution
- U.S.
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.
Code information (models, lots, serial numbers)
Lot Number: 170704A UDI: 20884521700861
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Situate G0804-16P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 recalls1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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