Trinity Sterile, Inc. 22202Recalls & reported problems
Trinity Sterile, Inc. · VAG SPEC LRG NS W/LIGHT · Class 1
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 10841767106386), received between Dec 1, 2023 and Dec 1, 2023 — classified as 1 malfunction.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2023
THE PACKAGE LABEL FOR TRINITY STERILE'S DISPOSABLE VAGINAL SPECULUM LARGE (ITEM NO. 22202) AND, PRESUMABLY, OTHER SIZES, GIVES THE IMPRESSION THAT THE PRODUCT IS STERILE WHEN IT IS NOT. THE WORD STERILE APPEARS IN VERY LARGE LETTERS AT THE TOP OF THE PACKAGE LABEL (AS PART OF THE BRAND NAME TRINITY STERILE), WHILE THE WORD NON-STERILE APPEARS ONLY IN MINUSCULE LETTERS OFF TO THE SIDE OF THE LABEL IN A TRIANGLE, NEXT TO THE "NO LATEX" AND "SINGLE USE ONLY" ICONS. I CAN TELL YOU THAT THE LABELING LED TO THE MISTAKEN IMPRESSION THAT THIS IS A STERILE SPECULUM, AND IT HAS BEEN USED UNDER THAT ASSUMPTION FOR SOME TIME ON OUR LABOR AND DELIVERY UNIT. WHILE I CANNOT POINT TO A SPECIFIC HARM THAT HAS REACHED A PATIENT, I CAN SAY THAT USING A NON-STERILE SPECULUM HAS THE POTENTIAL, UNDER SPECIFIC CIRCUMSTANCES, TO CAUSE HARM DURING A PREGNANCY, AS WITH PRETERM PREMATURE RUPTURE OF MEMBRANES. THE LABEL SHOULD CLEARLY STATE "NON-STERILE" IN VERY PROMINENT LETTERING, PROXIMATE TO AND MORE POMINENT THAN THE MISLEADING BRAND NAME "TRINITY STERILE," TO REMOVE ANY CONFUSION ABOUT THE STERILITY OF THIS SPECULUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18257637 ↗
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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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