Agency classClass IIOur severity:High FDA (Devices)·Z-1330-2024·Announced 2024-03-27

Laparotomy Sponges recalled for incomplete sterilization and missing RF detection

Covidien is recalling Situate Laparotomy Sponges because some packs may contain improperly sterilized units lacking required RF detection features. Non-sterile sponges could cause infection, tissue trauma, and sepsis during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving surgical sponges with potential for serious infection and sepsis if non-sterile units are used in surgical procedures. No illnesses or injuries have been reported. Per the rubric, Class II recalls without reported hospitalizations that present risk of serious harm score as High (3).

Plain-English summary

Covidien is recalling the Situate Laparotomy Sponge (REF: L1818-04P01C-1) because certain packs may contain incorrect product that was not steam pre-treated prior to sterilization. These sponges are treated with ethylene oxide but lack the required RF (radio frequency) detection tag.

The affected product was distributed nationwide to 34 states, with affected lot numbers 230504KF, 220903KF, and 221102KF. Approximately 755,800 units are involved in this recall. If these non-sterile sponges are used in surgical procedures, they may cause infection, tissue trauma, and sepsis.

Healthcare facilities that received affected lots should immediately identify and quarantine the product. Facility staff should verify the presence of the RF tag on laparotomy sponges before use. Any distributed sponges without the RF tag or steam pre-treatment should not be used in surgical procedures.

The recalled product

Product: Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Manufacturer: Covidien
Category: Medical Device — Surgical Sponge
Hazard: non-sterile
infection
sepsis
tissue-trauma
sterilization-failure
Affected units: 755,800

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

UDI-DI: 20884521700953
10884521700956. Lots: 230504KF
220903KF
221102KF

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

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