Medical Action Industries B250Recalls & reported problems
Medical Action Industries Inc. · Sponge: Lap 18X18 Pret W · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50809160000029), received between Nov 1, 2018 and Nov 1, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY, VAST024/LOT#1219829, WHICH INCLUDES THE FOLLOWING COMPONENT: SPONGE, LAP 18X18 PW 5S LOOPS, VENDOR PART # B250/ LOT # 1606JK326C MANUFACTURED BY (B)(4) PROVINCE JIANERKANG. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(4) 2018 ORIGINATED BY (B)(6), RN, CNOR /ASSISTANT NURSE MANAGER OF (B)(6) MEDICAL CENTER. THE COMPLAINT ALLEGES WHITE PARTICULATES WERE NOTICED ON A PATIENT'S HEART WHEN THE SPONGE WAS REMOVED FROM CHEST DURING PROCEDURE. THESE PARTICULATES WERE REMOVED USING FORCEPS AND A THOROUGH SEARCH WAS CONDUCTED OF THE PATIENT'S PERICARDIUM, BUT NO MORE ADDITIONAL PARTICULATES WERE DISCOVERED. THE AFFECTED LAP SPONGE WAS CONTAMINATED THEREFORE THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION; HOWEVER, PHOTOS WERE PROVIDED. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER (B)(4) PROVINCE JIANERKANG CONCERNING THE LAP SPONGE DEBRIS FOR FURTHER INVESTIGATION AND CORRECTIVE ACTION IMPLEMENTATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8030246 ↗
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.
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