Medline SYR100227Recalls & reported problems
Medline Industries, Inc. · NEEDLE,22GX1.5",REG,BEVEL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30080196305531), received between Jan 3, 2025 and Sep 24, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Incomplete or Inadequate Connection1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Puncture/Hole
It was reported that SYR100227Z have holes in the caps at the end of the needles, which makes them non-sterile.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882802 ↗MalfunctionAug 28, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
THE CUSTOMER REPORTED THAT WHEN USING OUR 22G NEEDLES CONNECTED TO A BD 30ML SYRINGE, THE NEEDLE RETRACTED INTO THE HUB DURING USE. THE ISSUE MAY BE RELATED TO BONDING, THE NEEDLE MIGHT NOT HAVE BEEN SECURELY BONDED, CAUSING IT TO RETRACT WHEN SUBJECTED TO FORWARD FORCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912007 ↗InjuryJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE FACILITY THE NEEDLE DETACHED FROM THE SYRINGE AND "SHOT OFF INTO THE PATIENT STOMACH".
Patient problems: Foreign Body In Patient
MAUDE report 21147982 ↗InjuryJan 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
FULL DOSE OF MEDICATION NOT BEING ADMINISTERED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21066518 ↗
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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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