LEADER 4817904Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00096295125665), received between May 18, 2022 and Mar 28, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2023Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER ADVISED THAT SOME OF THE LANCETS FROM THE BOX WERE BENT WHEN SHE REMOVED THE PROTECTIVE COVERING TO EXPOSE THE NEEDLE. CUSTOMER ADVISED THAT PRODUCT WAS SEALED AND INTACT WHEN SHE RECEIVED IT. THE CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE SINCE (B)(6) 2022. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER DID NOT CLAIM TO BE INJURED USING THE LANCETS AND NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630149 ↗
• MalfunctionJun 7, 2022Product Quality Problem; Defective Component; Product Quality Problem; Defective Component

  CONSUMER REPORTED COMPLAINT FOR THE 33G MULTI-COLOR TRUEPLUS LANCETS. CUSTOMER STATED THAT PART OF THE CAP STAYED ON THE SURFACE OF THE NEEDLE AFTER SHE HAD REMOVED IT; CUSTOMER STATED IT WAS "A PIECE OF PLASTIC CHUNK." CUSTOMER IS USING THE PRODUCT OUT OF THIS PACKAGE FOR THE FIRST TIME AND STATED THAT ALL OF THE LANCETS SHE HAS USED SO FAR HAVE HAD THE SAME ISSUE. CUSTOMER STATED THAT SHE IS NOT ABLE TO LANCE HER FINGER AND SHE IS NOT ABLE TO OBTAIN A BLOOD SAMPLE USING THE LANCETS. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER FEELS 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 14621027 ↗
• MalfunctionMay 18, 2022Product Quality Problem; Defective Component; Product Quality Problem; Defective Component

  CONSUMER REPORTED COMPLAINT FOR THE 33G TRUEPLUS LANCETS. DISTRIBUTOR CONTACTED MANUFACTURER ON BEHALF OF THE CUSTOMER; DISTRIBUTOR INTERNAL REPORT REFERENCE NUMBER: (B)(4) MANUFACTURER CONTACTED CUSTOMER VIA TELEPHONE. CUSTOMER STATED THAT THE MULTI-COLOR LANCETS HAD A "BIG BLOB" OF PLASTIC ON THE TIP AND THAT THEY ARE UNABLE TO PIERCE HER SKIN. CUSTOMER DID NOT HAVE ANY OF THE LANCETS; CUSTOMER HAD RETURNED TO PHARMACY. THE CUSTOMER FEELS 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 14427530 ↗