Covidien Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Brand
Covidien
Lot Codes / Batch Numbers
UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
Products Sold
UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
Covidien is recalling Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 due to Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 2/21/24, recall notices were mailed to customers and distributors who were asked to do the following: 1) Do not use impacted products. 2) Remove, quarantine, and return all unused affected product. 3) This communication needs to be passed to all those who need to be aware within your organization where impacted devices have been transferred, and to any other associated organizations that may be impacted by this action. 4) Complete and return the customer confirmation form to rs.gmbmitgfca@medtronic.com Customers with questions can contact the firm at 800-962-9888 Option 2.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
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