Livongo Lancing DeviceRecalls & reported problems
Livongo Health, Inc · Lancing Device, Bag of 1 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00853553005219), received between Mar 28, 2024 and Jul 23, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (K133584); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Material Fragmentation1
Patient problems
- Ecchymosis1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT REPORTED AN INFECTION AFTER PUNCTURING THEIR SKIN WITH THEIR LANCING DEVICE. THE PATIENT WENT TO THE EMERGENCY ROOM TO SEEK MEDICAL ATTENTION DUE TO A FEVER, BUT DIDN'T PROVIDE DETAILS OF THE MEDICAL TREATMENT RECEIVED.
Patient problems: Unspecified Infection
MAUDE report 19806026 ↗MalfunctionMar 28, 2024Material Fragmentation; Material Fragmentation
THE PATIENT REPORTED PLASTIC PARTICLES FROM THE LANCING DEVICE WENT UNDER HER SKIN SEVERAL TIMES. THE PATIENT REMOVED THE PARTICLES USING TWEEZERS AND OR A NEEDLE. THE PATIENT REPORTED THERE WAS VERY SLIGHT DISCOLORATION OF HER SKIN, HOWEVER, THE PATIENT DID NOT SEEK MEDICAL ATTENTION.
Patient problems: Ecchymosis
MAUDE report 18990592 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K133584. One submission often covers many models, so check the product and lot details in each record.
- Z-1587-2016 · Feb 18, 2016 · TerminatedThe Livongo Health In Touch Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes
Other Lancet, Blood devices
- BD Microtainer® Contact-Activated Lancet 366593Becton, Dickinson And Company · Lancet, blood89 reports
- 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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