CARDINAL HEALTH SLMF200Recalls & reported problems
Cardinal Health 200, LLC · LANCET SAFETY MED FLOW NEEDLE GAUGE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20885380025843), received between Nov 13, 2025 and Jun 26, 2026 — classified as 9 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (16 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
- Retraction Problem16
- Misfire2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Exposure to Body Fluids2
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE GRAY TWIST TOP THAT YOU HAVE TO PULL OFF ISN'T COMING OFF EASILY AS IT SHOULD, AND THE NEEDLE DOESN'T RETRACT AT ALL AFTER USE- IT IS STICKING OUT ABOUT 8TH OF AN INCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641990 ↗InjuryJun 10, 2026Retraction Problem; Misfire
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS REPORTED THERE HAVE BEEN 3 CASES OF NEEDLESTICK INJURY DURING USE OF THIS PRODUCT. BOTH ISSUES HAVE OCCURRED: 1. NOT FIRING (DISCHARGING ) AFTER TOP IS TWISTED OFF. 2. AFTER FIRING (DISCHARGING) THE NEEDLES IS STILL EXPOSED (NOT RETRACTING). PT CODE: 4559. DEVICE CODES: 1536, 2532.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460515 ↗InjuryJun 10, 2026Retraction Problem; Misfire
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS REPORTED THERE HAVE BEEN 3 CASES OF NEEDLESTICK INJURY DURING USE OF THIS PRODUCT. BOTH ISSUES HAVE OCCURRED: 1. NOT FIRING (DISCHARGING) AFTER TOP IS TWISTED OFF. 2. AFTER FIRING (DISCHARGING) THE NEEDLES IS STILL EXPOSED (NOT RETRACTING). PT CODE: 4559 DEVICE CODES: 1536, 2532.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460511 ↗InjuryMay 21, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS REPORTED THAT THE NEEDLE DID NOT RETRACT AND WAS STUCK WHEN PICKING DEVICE UP AFTER USING. MEDICAL QUESTIONNAIRE RECEIVED MAY 06, 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247724 ↗InjuryMay 21, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS REPORTED THAT THE NEEDLE DID NOT RETRACT AND WAS STUCK WHEN PICKING DEVICE UP AFTER USING. MEDICAL QUESTIONNAIRE RECEIVED (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247723 ↗InjuryMay 21, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT TAN EMPLOYEE WAS INJURED DUE TO NEEDLE STICK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244031 ↗MalfunctionApr 29, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE NEEDLE IS NOT DISCHARGING/ RETRACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035838 ↗MalfunctionApr 29, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE NEEDLE IS NOT DISCHARGING/ RETRACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035837 ↗MalfunctionApr 17, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE NEEDLE IS NOT DISCHARGING/ RETRACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916186 ↗MalfunctionApr 17, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE NEEDLE IS NOT DISCHARGING/ RETRACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916181 ↗InjuryApr 17, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE NEEDLE IS NOT DISCHARGING/ RETRACTING AND A STAFF MEMBER WAS STUCK BY THE LANCET AFTER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916180 ↗MalfunctionApr 17, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE NEEDLE IS NOT DISCHARGING/ RETRACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916179 ↗InjuryApr 17, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE NEEDLE IS NOT DISCHARGING/ RETRACTING AND A STAFF MEMBER WAS STUCK BY THE LANCET AFTER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916178 ↗MalfunctionApr 17, 2026Retraction Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE NEEDLE IS NOT DISCHARGING/ RETRACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916177 ↗InjuryNov 13, 2025Retraction Problem; Retraction Problem
CNA USED LANCET ON PATIENT AND SET DOWN LANCET TO COMPLETE BLOOD SUGAR. UPON GATHERING UP SUPPLIES USED, CNA WAS STUCK WITH THE PATIENT'S USED LANCET BECAUSE IT DID NOT RETRACT AFTER USED.
Patient problems: Exposure to Body Fluids
MAUDE report 23549398 ↗InjuryNov 13, 2025Retraction Problem; Retraction Problem
CNA USED LANCET ON PATIENT AND SET DOWN LANCET TO COMPLETE BLOOD SUGAR. UPON GATHERING UP SUPPLIES USED, CNA WAS STUCK WITH THE PATIENT'S USED LANCET BECAUSE IT DID NOT RETRACT AFTER USED.
Patient problems: Exposure to Body Fluids
MAUDE report 23549364 ↗
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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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