LEADER 4817912Recalls & reported problems
Cardinal Health 110, Inc. · Sterile Lancets 30 Gauge · Class 2
Data updated Oct 16, 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 00096295125672), received between Jan 12, 2023 and Jan 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Product Quality Problem” (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 16, 2026.
Most reported problems
Device problems
- Product Quality Problem1
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.
MalfunctionJan 12, 2023Product Quality Problem; Product Quality Problem
CONSUMER REPORTED COMPLAINT FOR THE 30G LANCETS. COMPLAINT WAS INITIALLY REPORTED BY DISTRIBUTOR VIA E-MAIL AND CUSTOMER WAS CONTACTED VIA TELEPHONE. CUSTOMER STATED THAT THE NEEDLE HAD COME OFF WHEN HE PULLED THE TOP OFF THE LANCETS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR 2 WEEKS. CUSTOMER IS USING A COMPETITOR'S LANCING DEVICE. 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 16147140 ↗
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- BD Microtainer® Contact-Activated Lancet 366594Becton, Dickinson And Company · Lancet, blood64 reports
- OneTouch Ultrasoft 020-393LifeScan Europe GmbH · Lancet, Blood1 recall0 reports
- CARDINAL HEALTH SLMF200Cardinal Health 200, LLC · Lancet, blood16 reports
- BD Microtainer® Contact-Activated Lancet 366592Becton, Dickinson And Company · Single use only blood lancet with an integral sharps injury prevention feature14 reports
- Medline MPHSFTY28Medline Industries, Inc. · Single use only blood lancet with an integral sharps injury prevention feature6 reports
- Unistik Touch AT 1444Owen Mumford Limited · Lancet, Blood4 reports
- Unistik 3 AT1014Owen Mumford Limited · Lancet, Blood3 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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