Medline MDS092005Recalls & reported problems
Medline Industries, Inc. · GEL,ULTRASOUND,BOTTLE,8.5-OZ,BLUE · Class 2
Data updated Oct 16, 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 10080196166251), received between Jul 16, 2020 and Jul 16, 2020 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, THAT THE REPORTER'S SON HAD AN ULTRASOUND. AFTER RETURNING HOME, SON TOOK A BATH AND SHE NOTICED THAT HE HAD A RASH.
Patient problems: Rash
MAUDE report 10283465 ↗
Other Media, coupling, ultrasound devices
- PinPoint 9A10000Bard Access Systems, Inc. · Media,coupling,ultrasound88 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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