MEDLINE MDS251518LFRecalls & reported problems
Medline Industries, Inc. · SPONGE,LAP,18"X18",DLX,XR,ST,5/PK,40/PK · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196743926), received between Jul 21, 2023 and Sep 16, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Contamination” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination1
- Device Contamination with Chemical or Other Material1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2025Contamination; Contamination
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, A LAP SPONGE THAT WAS "USED ON PATIENT IN INCISION TO SOAK UP BLOOD" WAS FOUND TO HAVE A HAIR IN IT.
Patient problems: Foreign Body In Patient
MAUDE report 23062237 ↗MalfunctionJul 21, 2023Device Contamination with Chemical or Other Material
MEDLINE LAP SPONGES OPENED FOR EP (ELECTROPHYSIOLOGY) PROCEDURE TABLE, UPON INSPECTION BY STAFF THERE WAS A CLUSTER OF DUST PROCESSED WITH THE LAPS. THE LAPS WERE THROWN OFF AND ENSURED NO TABLE OR STERILE EMPLOYEE CONTAMINATED. BARCODE ON LAPS WAS (B)(4), REF #MDS251518LF, 18X18 SPONGES. THESE SPONGES WERE NOT USED IN PATIENT CASE AND DISCARDED.
Patient problems: Insufficient Information
MAUDE report 17370211 ↗
Other Gauze/sponge, internal, x-ray detectable devices
- Vistec 7317Cardinal Health, Inc. · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall80 reports
- Situate G0804-12P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE120 reports
- Situate G0404-16P01CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE114 reports
- Situate G0804-16P02CN-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE2 recalls1 report
- Situate L1818-04P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall20 reports
- Situate G0404-16P01C-1Covidien LP · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE60 reports
- Arterial Line Kit 400115AArgon Medical Devices, Inc. · Gauze/Sponge, Internal, X-Ray Detectable1 recall0 reports
- AMD-RITMED 55992CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page