TRUEplus TRUEplus Sterile Lancets (REF 743533)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00021292004484), received between Aug 30, 2021 and Mar 2, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER STATED THAT AFTER TESTING, SHE ATTEMPTED TO RE-CAP THE NEEDLE BUT THE NEEDLE BROKE; PER THE CUSTOMER, SHE COULDN'T FIND THE NEEDLES. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER DID NOT MENTION HOW LONG SHE HAS BEEN USING THE LANCETS. 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 LANCETS, AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24479846 ↗
• MalfunctionJun 13, 2022Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS 33G LANCETS. CUSTOMER STATED THAT THE TIP ON SOME OF THE NEEDLES IS BENT. CUSTOMER STATED THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR ONE MONTH. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM THEY WERE INJURED WHILE USING THE LANCETS AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674694 ↗
• MalfunctionMar 24, 2022Break; Component Missing; Break; Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS 33G LANCETS. CUSTOMER STATED THAT HE HAD JUST PURCHASED A BOX OF 100 LANCETS AND THAT SOME ARE BROKEN AND OTHERS ARE MISSING THE NEEDLE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. COORDINATOR HAD INITIALLY SPOKEN WITH CUSTOMER AND TRANSFERRED CUSTOMER'S INFORMATION TO TECHNICIAN. TECHNICIAN WAS UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893146 ↗
• InjuryAug 30, 2021Component Missing; Manufacturing, Packaging or Shipping Problem; Component Missing; Manufacturing, Packaging or Shipping Problem

  CONSUMER REPORTED COMPLAINT VIA E-MAIL FOR THE TRUEPLUS 33G LANCETS. CUSTOMER STATED THAT SHE HAD EXPERIENCED PAIN AFTER USING THE LANCET, AND THAT THE LANCET HAD TWO NEEDLES (DOUBLE NEEDLE). CUSTOMER ALSO STATED THAT A FEW WEEKS PRIOR ONE OF THE LANCETS HAD BEEN MISSING THE NEEDLE. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER DID NOT PROVIDE CONTACT TELEPHONE NUMBER; EMAIL RESPONSE HAD BEEN SENT TO CUSTOMER.

  Patient problems: Pain

  MAUDE report 12384751 ↗