Welch Allyn, Inc. 901071 (REF 410162)Recalls & reported problems
Welch Allyn, Inc. · 590 SMALL REFRESHED ASSEMBLY · 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 00732094214192), received between Jan 9, 2023 and Jan 9, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
MalfunctionJan 9, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING AN ANNUAL GYN EXAM AND PAP, WITH USE OF A KLEENSPEC (SIZE SMALL), THE ¿LOWER BILL OF SPECULUM BROKE, SPLIT LENGTHWISE¿ DURING USE. THE CUSTOMER STATES A ¿SMALL AMOUNT OF VAGINAL BLEEDING¿ OCCURRED, HOWEVER THERE WAS NO ALLEGATION OF MEDICAL INTERVENTION OR DELAY FROM THE EVENT. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
Patient problems: Laceration(s)
MAUDE report 16120970 ↗
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.
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