Z-1330-2024Class II

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

Name: Z-1330-2024 Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Creator: Covidien
Published: 2024-02-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-02-21 / Open, Classified / root cause: labeling and UDI

FDA source

Covidien began a recall of Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 on 2024-02-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1330-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-21
Posted: 2024-03-21
Recalling firm: Medtronic, Inc.
Product: Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 755,800
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 codes and lots: UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1330-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1330-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-21

Product code GDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)