Biogel® Surgeons 30485Recalls & reported problems
Mölnlycke Health Care AB · Biogel Surgeons 8.5 x 50 US · Class 1
Data updated Oct 16, 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 05060097930906), received between Mar 19, 2020 and Mar 19, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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 16, 2026.
Most reported problems
Device problems
- Device Contamination with Body Fluid1
- Packaging Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2020Device Contamination with Body Fluid; Packaging Problem
MOLNLYCKE BIOGEL SURGEONS NATURAL RUBBER LATEX SURGICAL GLOVES, SIZE 8 1/2, REF 30485, EXP 08/28/2022, LOT 191671 - OPENED OUTER PACKAGE AND LONG DARK HAIR SEEN WITHIN THE PACKAGE. PACKAGING AND HAIR SAVED; NO PATIENT EXPOSURE; NO CONTAMINATION OF FIELD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9853247 ↗
Other Surgeon's gloves devices
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- PROTEXIS 2D72PT65XCardinal Health 200, LLC · Surgeon's gloves1 recall2 reports
- Medline Industries, Inc. DYNJ63673DMedline Industries, Inc. · Surgeon's gloves1 recall1 report
- GAMMEX 20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall1 report
- NOVAPLUS V20685275Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685290Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685280Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- PROTEXIS 2D72PL65XCardinal Health 200, LLC · 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 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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