Reported Mar 27, 2024 · Ongoing

Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1

Covidien

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien · 200 Medtronic Dr · Lafayette, CO · 80026

Is this the product you have?

  • Situate Laparotomy Sponge, RF and X-ray Detectable
  • REFL1818-04P01C-1
Lot codes and dates
  • UDI-DI
    • 20884521700953
    • 10884521700956
  • Lots
    • 230504KF
    • 220903KF
    • 221102KF
Amount recalled
755,800

Where it was sold

Why it was recalled

Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.