MEDLINE AVT0270Recalls & reported problems
Medline Industries, Inc. · GLOVE,SURG,ADVANTAGE PI UNDRGLV,LF,PF,7 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10197344099702), received between Sep 10, 2026 and Sep 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Material Separation1
- Material Split, Cut or Torn1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Material Fragmentation; Material Separation; Material Split, Cut or Torn
It was reported that, product tears when donning gloves, and the product was flaking off during use. The portion of shredded surgical glove fell into patient's mediastinum. The surgeon noticed at 1106 but unaware of when glove became contaminated and whose glove had a hole in it. The surgeon, medical student and first assist removed and replaced gloves. The wound class changed to contaminated from break in sterile technique. What was the original intended procedure? cabg (coronary artery bypass graft), coronary artery bypass grafting times, left internal mammary artery takedown, endoscopic left saphenous vein harvesting; transesophageal echocardiogram; cystoscopy, foley placement by urology service.
Patient problems: Foreign Body In Patient
MAUDE report 50713481 ↗
Other Surgeon's gloves devices
- GAMMEX 20685275Ansell Healthcare Product · Surgeon'S Gloves2 recalls0 reports
- PROTEXIS 2D72PT65XCardinal Health 200, LLC · Surgeon's gloves1 recall2 reports
- GAMMEX 20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall1 report
- Medline Industries, Inc. DYNJ63673DMedline Industries, Inc. · Surgeon's gloves1 recall1 report
- GAMMEX 20685255Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685290Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685260Ansell Healthcare Product · Surgeon'S Gloves1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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