Stop using nowMedical device recall · FDA · Published February 21, 2024
Covidien Situate Laparotomy Sponges May Cause Infection If Not Sterilized Properly
Covidien recalls specific laparotomy sponges that may not be properly sterilized, risking infection and tissue damage during surgery. Affected sponges have unique identifiers and were sold in certain lots.
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.
Take action
Contact the company
📍Recalling firmCovidien200 Medtronic Dr · Lafayette, CO 80026
“Covidien Situate Laparotomy Sponges May Cause Infection If Not Sterilized Properly.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56123-covidien-situate-laparotomy-sponges-may-cause-infection-if-not-sterilized. Based on FDA recall #Z-1330-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1330-2024%22&limit=1).
The FDA announced on Feb. 21, 2024, that Covidien is recalling Situate Laparotomy Sponges because non-sterile packs may cause infection or sepsis. The agency issued recall number Z-1330-2024 for the Class II voluntary recall.
How to tell if you have it
Brand: Covidien
Product: Situate Laparotomy Sponge, RF and X-ray Detectable
REF: L1818-04P01C-1
UDI-DI: 20884521700953, 10884521700956
Lots: 230504KF, 220903KF, 221102KF
The hazard
According to the FDA, packs of five sponges may contain incorrect product with a blue loop and X-ray detectable feature but no RF tag. If non-sterile due to lack of steam pre-treatment, this could lead to infection, tissue trauma, and sepsis.
Context
GovInfoNow's records show Covidien has 14 other recalls on record since March 5, 2021. Other recent recalls include the Covidien Bedside SpO2 Monitor (June 23, 2025), the Covidien Newport HT70 Ventilator (May 21, 2025), and the Covidien Shiley Tracheostomy Tube (Feb. 26, 2025).
How to tell if you have this one
Check for the unique identifiers: UDI-DI 20884521700953 or 10884521700956. The affected lots are 230504KF, 220903KF, and 221102KF.
Brand
Covidien
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Recalled Sponges
Immediately stop using any sponges with the unique identifiers 20884521700953 or 10884521700956.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 34 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1330-2024 (February 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1330-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.