FDA Devices recall · Reported March 27, 2024
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
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'…
Covidien recalled Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 - a moderate-severity action.
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 was recalled by Covidien in March 27, 2024. Reason: Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable featur…. Check the official notice for the remedy. Verify recall #Z-1330-2024 with the FDA Devices before acting.
The recall
Covidien issued this moderate-severity FDA Devices recall-Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable featur….
- Moderate
- severity level
- 756K units
- affected scope
- Class II
- classification
- March 27, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1330-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1330-2024 |
| Date reported | March 27, 2024 |
| Date initiated | February 21, 2024 |
| Recalling firm | Covidien |
| Firm location | Lafayette, CO |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1330-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026