Welch Allyn, Inc. 901071 (REF 58000S-B)Recalls & reported problems
Welch Allyn, Inc. · Welch Allyn KleenSpec 580 Series Disposable Vaginal Specula with Attached Sheath, Small; Qty. 18 · Class 2
Data updated Oct 18, 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 00732094103540), received between Mar 4, 2022 and Mar 4, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2022Break
WHILE DOCTOR WAS PERFORMING A VAGINAL EXAM, THE PLASTIC SPECULUM BROKE CAUSING VAGINAL LACERATIONS.
Patient problems: Laceration(s)
MAUDE report 13666366 ↗
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
- Welch Allyn, Inc. 901071Welch Allyn, Inc. · Speculum, vaginal, nonmetal2 reports
- MEDLINE DYND70401SMedline Industries, 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.
How reports and recalls are matched · Editorial policy · Report an error on this page