MEDLINE GEM5145TCRecalls & reported problems
Medline Industries, Inc. · WRAP, BONDED, BLUE PINK, 45X45 GEM5 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20197344695239), received between May 27, 2026 and Aug 31, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).
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 Puncture/Hole2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Material Puncture/Hole
It was reported that "clinic had to cancel a surgical procedure today because they found holes in the sterilization wrap."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534280 ↗MalfunctionMay 27, 2026Material Puncture/Hole
IT WAS REPORTED THAT THESE WERE URETEROSCOPES, ABOUT 7LBS - FAR BELOW THE WEIGHT LIMIT. THERE WERE HOLES IN UNEXPECTED PLACES - SOME NOT EVEN ON THE BOTTOM OR CREASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308028 ↗
Other Wrap, sterilization devices
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- Turbett Surgical TS1000Turbett Surgical Inc · Wrap, Sterilization1 recall0 reports
- Turbett Surgical TS1200Turbett Surgical Inc · Wrap, Sterilization1 recall0 reports
- Halyard 34164O&M Halyard, Inc. · Wrap, sterilization11 reports
- Halyard 34145O&M Halyard, Inc. · Wrap, sterilization5 reports
- Halyard 34147O&M Halyard, Inc. · Wrap, sterilization3 reports
- Halyard 34199O&M Halyard, Inc. · Wrap, sterilization3 reports
- Halyard 34148O&M Halyard, Inc. · Wrap, sterilization3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.