Covidien Situate Gauze RF/X-Ray Detectable: Risk of Undetected Use
Covidien recalls Situate Gauze RF and X-Ray detectable products due to potential failure to detect by the Situate console from a manufacturing error. Affected items have Product Number G0804-16P02CN-1 and Lot Number 170704A.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Covidien is recalling Situate Gauze RF and X-Ray detectable products because they might not be detected by the Situate console due to a manufacturing error. This could lead to undetected use during medical procedures, which is a safety risk. Read more at govinfonow.com/recall/72862-covidien-situate-gauze-rf-x-ray-detectable-risk-of-undetected.
Source Summary by GovInfoNow · govinfonow.com/recall/72862-covidien-situate-gauze-rf-x-ray-detectable-risk-of-undetected · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1130-2018
Cite this page
“Covidien Situate Gauze RF/X-Ray Detectable: Risk of Undetected Use.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72862-covidien-situate-gauze-rf-x-ray-detectable-risk-of-undetected. Based on FDA recall #Z-1130-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1130-2018%22&limit=1).
Why it’s dangerous
The gauze products have a radiofrequency (RF) tag sewn into the green pouch that should be detected by the Situate console. A manufacturing error may cause the console to fail to detect these products, potentially leading to undetected use during medical procedures.
Who’s affected
Patients and medical staff using Situate Gauze RF and X-Ray detectable products for medical procedures. Those using the products with the Situate delivery system are most at risk.
How to tell if you have this one
Check for Product Number G0804-16P02CN-1 and Lot Number 170704A on the packaging. The gauze is a single-use disposable item that must be used with the Situate delivery system.
- Brand
Covidien- Category
Medical device
What to do — step by step
Check Product Details
Look for Product Number G0804-16P02CN-1 and Lot Number 170704A on the packaging to confirm if the item is affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of injury from this product?
The recall addresses a potential failure to detect the product during medical procedures, not a direct injury risk. The hazard is related to undetected use, not physical harm.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1130-2018 (October 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1130-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.