Welch Allyn, Inc. 901071 (REF 411251)Recalls & reported problems
Welch Allyn, Inc. · 590 LARGE DLV ASSEMBLY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00732094222272), received between Sep 10, 2026 and Sep 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
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.
MalfunctionSep 10, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723642 ↗MalfunctionSep 10, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723298 ↗
Other Speculum, vaginal, nonmetal devices
- HSG Tray 6050TCoopersurgical, Inc. · Speculum, Vaginal, Nonmetal1 recall0 reports
- Welch Allyn, Inc. 901071Welch Allyn, Inc. · Speculum, vaginal, nonmetal4 reports
- Welch Allyn, Inc. 901071Welch Allyn, Inc. · Speculum, vaginal, nonmetal3 reports
- MEDLINE DYND70401SMedline Industries, Inc. · Speculum, vaginal, nonmetal1 report
- Welch Allyn, Inc. 901071Welch Allyn, Inc. · Speculum, vaginal, nonmetal1 report
- Welch Allyn, Inc. 901071Welch Allyn, Inc. · Speculum, vaginal, nonmetal1 report
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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