Medline SYR100235Recalls & reported problems
Medline Industries, Inc. · NEEDLE,23GX1",REG,BEVEL · Class 2
Data updated Oct 18, 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 30080196305548), received between Nov 10, 2025 and Sep 18, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Connection 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
- Decoupling1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Decoupling
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822315 ↗InjuryNov 10, 2025Connection Problem; Connection Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 "THE 23 G NEEDLE WAS BEING USED TO ADMINISTER AN INTRAMUSCULAR GLUTEAL INJECTION" AND THE SYRINGE "POPPED OFF THE NEEDLE AND THE CONTENTS OF THE SYRINGE SPRAYED OUT." THE CUSTOMER STATED THAT "NONE OR VERY LITTLE OF THE CONTENTS OF THE SYRINGE WERE ADMINISTERED" AND THAT THE NEEDLE WAS "REMOVED WITH NO COMPLICATIONS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509627 ↗
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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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