TRUEplus TRUEplus Pen Needles 5Bevel - 31G 8mmRecalls & reported problems
Trividia Health, Inc. · Walgreens TRUEplus Pen Needles 5Bevel - 31G 8mm - 50ct box · Class 2
All models of TRUEplus (37)
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 00311917136325), received between Nov 20, 2023 and Feb 6, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “No Flow” (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
- No Flow2
- Product Quality Problem1
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.
MalfunctionFeb 6, 2026No Flow
CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THE PEN NEEDLES WERE NOT DISPENSING THE INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS NOT USING COMPATIBLE PRODUCT. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24284210 ↗MalfunctionNov 20, 2023Product Quality Problem; No Flow; Product Quality Problem; No Flow
CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS PEN NEEDLES. CUSTOMER STATED THE 31G PEN NEEDLES DID NOT DISPENSE HER INSULIN. CUSTOMER ALSO STATED THE PEN NEEDLES HAVE TOO MUCH SILICONE THAT WON'T LET THE INSULIN COME OUT. CUSTOMER STATED THAT HALF OF THE PEN NEEDLES IN THE BOX ARE DEFECTIVE. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PEN NEEDLES FOR THE PAST TWO WEEKS. THE CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE IS ALIGNED PROPERLY. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18176637 ↗
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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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