Situate recallZ-1330-2024 · Covidien · initiated Feb 21, 2024
Open, Classified
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 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
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.
FDA root cause category: Labeling mix-ups
What the company is doing
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 [email protected] Customers with questions can contact the firm at 800-962-9888 Option 2.
Recall details
- Recall number
- Z-1330-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 21, 2024
- Posted by the FDA
- Mar 21, 2024
- Recalling firm
- Covidien
- Quantity
- 755,800
- Product code
- GDY
- 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.
Product description
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Code information (models, lots, serial numbers)
UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Situate L1818-04P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall20 reports
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 16, 2026. Text above is shown as published by the FDA.
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