Medline SYR100257Recalls & reported problems
Medline Industries, Inc. · NEEDLE,25GX1.5",REG,BEVEL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 30080196305579), received between Aug 23, 2021 and Sep 28, 2026 — classified as 4 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (11 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
- Obstruction of Flow11
- Complete Blockage6
- Break3
- Packaging Problem3
- Physical Resistance/Sticking2
- Appropriate Device Problem Term/Code Not Available1
- Failure to Deliver1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Foreign Body In Patient3
- Bruise/Contusion1
- Insufficient Information1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916155 ↗MalfunctionSep 23, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873414 ↗MalfunctionSep 23, 2026Obstruction of Flow
It was reported that 4 boxes of needles were "stopping up before completely empty."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872885 ↗MalfunctionSep 22, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856131 ↗MalfunctionSep 21, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841447 ↗MalfunctionSep 18, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828485 ↗MalfunctionSep 18, 2026Packaging Problem
It was reported that "THE CAPS ARE COMING OFF TOO EASILY ON THE NEEDLES. \"SOMETHING APPEARS TO BE LOOSE\""
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818702 ↗MalfunctionSep 12, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745595 ↗MalfunctionSep 12, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745587 ↗InjuryApr 23, 2026Break
ACCORDING TO THE FACILITY ON (B)(6) 2026, THE "PRODUCT WAS BEING USED FOR A THYROID BIOPSY" AND "IN THE PROCESS OF TRYING TO RETRIEVE SPECIMEN, NEEDLE BROKE OFF AT THE HUB FROM CYTOCORE MACHINE" INTO "THE PATIENT'S THYROID."
Patient problems: Foreign Body In Patient
MAUDE report 24966203 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE BROKE OFF INTO THE PATIENT'S THYROID.
Patient problems: Foreign Body In Patient
MAUDE report 24949210 ↗MalfunctionJan 19, 2026Obstruction of Flow; Physical Resistance/Sticking
ACCORDING TO THE FACILITY, ON (B)(6) 2025, DURING A PROCEDURE WITH A STEROID INJECTION, THEY DREW 3ML OF LIDOCAINE THROUGH THE NEEDLE, SITE WAS LOCATED THROUGH ULTRASOUND, AND PROVIDER PROCEEDED TO ATTEMPT TO INJECT THE STEROID. HE WAS MET WITH ABNORMAL RESISTANCE AND REMOVED THE NEEDLE AND TRIED TO EXPEL AND THEN DISCOVERED THE BLOCKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24111608 ↗MalfunctionJan 19, 2026Obstruction of Flow; Physical Resistance/Sticking
ACCORDING TO THE FACILITY ON (B)(6) 2025, A PROVIDER WAS PERFORMING A STEROID INJECTION USING A 25G X 1.5" NEEDLE. AFTER DRAWING 3 ML OF LIDOCAINE AND IDENTIFYING THE INJECTION SITE VIA ULTRASOUND, THE PROVIDER ATTEMPTED TO ADMINISTER THE MEDICATION BUT ENCOUNTERED ABNORMAL RESISTANCE. A SECOND INJECTION SITE WAS ATTEMPTED WITH THE SAME RESULT. THE NEEDLE WAS THEN REMOVED, AND A BLOCKAGE WAS IDENTIFIED WHEN ATTEMPTING TO EXPEL THE MEDICATION. A SECOND 25G X 1.5" NEEDLE WAS USED ON THE PATIENT AND FAILED IN THE SAME MANNER. A THIRD NEEDLE FROM THE SAME LOT WAS TESTED BUT NOT USED ON THE PATIENT; SALINE COULD BE DRAWN INTO THE SYRINGE, BUT COULD NOT BE EXPELLED DUE TO SEVERE RESISTANCE. THE FACILITY SUBSEQUENTLY SWITCHED TO A 25G X 1" NEEDLE FROM A DIFFERENT LOT AND COMPLETED THE INJECTION. THE PATIENT RECEIVED THREE ADDITIONAL NEEDLE STICKS DUE TO THE MALFUNCTIONING DEVICES, EXTENDING THE PROCEDURE, BUT NO SERIOUS INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108799 ↗MalfunctionNov 13, 2025Complete Blockage; Complete Blockage
THE NEEDLES ARE CLOGGING WITH THE INJECTIONS. CAUSING AN ISSUE WITH COMPLETING THE INJECTION, UNABLE AND NEED TO RE- STICK THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23540470 ↗InjuryOct 15, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE CLINICIANS WERE UNABLE TO ADMINISTER A STEROID MEDICATION DUE TO THE NEEDLE CLOGGING. THE NEEDLE WAS CHANGED AND THE INJECTION WAS ABLE TO BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301674 ↗InjuryDec 13, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY, WHEN WE GO TO INJECT A PATIENT'S BODY PART THERE IS A LARGE AMOUNT OF RESISTANCE AND CANNOT PUSH THE STEROID OR LIDOCAINE THROUGH THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 20924838 ↗InjuryJul 14, 2024Break; Break
ACCORDING TO THE CUSTOMER, ON (B)(6)2024 WHILE ATTEMPTING TO REMOVE NEEDLE AFTER INJECTING "LOCAL MEDICATION" FOR A "RECTAL EXAM" THE NEEDLE "BROKE OFF FROM THE HUB, LEAVING THE SHARP NEEDLE ITSELF IN THE TISSUE OF THE REGION".
Patient problems: Bruise/Contusion; Foreign Body In Patient
MAUDE report 19737558 ↗MalfunctionAug 24, 2021Complete Blockage
IT WAS REPORTED; "THE NURSES HAVE BEEN USING THIS SIZE FOR A CERTAIN INJECTION AND HAVE HAD THE ISSUE OF CLOGGING UP SO THEY ARE UNABLE TO PUSH THE MED THROUGH. THIS HAS CAUSED THE NURSING TO DO ANOTHER NEEDLE STICK IN ORDER TO HAVE THE INJECTION COMPLETED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12361931 ↗MalfunctionAug 24, 2021Complete Blockage
IT WAS REPORTED; "THE NURSES HAVE BEEN USING THIS SIZE FOR A CERTAIN INJECTION AND HAVE HAD THE ISSUE OF CLOGGING UP SO THEY ARE UNABLE TO PUSH THE MED THROUGH. THIS HAS CAUSED THE NURSING TO DO ANOTHER NEEDLE STICK IN ORDER TO HAVE THE INJECTION COMPLETED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12361434 ↗MalfunctionAug 24, 2021Obstruction of Flow
IT WAS REPORTED; "THE NURSES HAVE BEEN USING THIS SIZE FOR A CERTAIN INJECTION AND HAVE HAD THE ISSUE OF CLOGGING UP SO THEY ARE UNABLE TO PUSH THE MED THROUGH. THIS HAS CAUSED THE NURSING TO DO ANOTHER NEEDLE STICK IN ORDER TO HAVE THE INJECTION COMPLETED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12360795 ↗MalfunctionAug 24, 2021Complete Blockage; Failure to Deliver
IT WAS REPORTED; "THE NURSES HAVE BEEN USING THIS SIZE FOR A CERTAIN INJECTION AND HAVE HAD THE ISSUE OF CLOGGING UP SO THEY ARE UNABLE TO PUSH THE MED THROUGH. THIS HAS CAUSED THE NURSING TO DO ANOTHER NEEDLE STICK IN ORDER TO HAVE THE INJECTION COMPLETED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12360211 ↗MalfunctionAug 24, 2021Obstruction of Flow
IT WAS REPORTED; "THE NURSES HAVE BEEN USING THIS SIZE FOR A CERTAIN INJECTION AND HAVE HAD THE ISSUE OF CLOGGING UP SO THEY ARE UNABLE TO PUSH THE MED THROUGH. THIS HAS CAUSED THE NURSING TO DO ANOTHER NEEDLE STICK IN ORDER TO HAVE THE INJECTION COMPLETED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12360116 ↗MalfunctionAug 24, 2021Complete Blockage
IT WAS REPORTED; "THE NURSES HAVE BEEN USING THIS SIZE FOR A CERTAIN INJECTION AND HAVE HAD THE ISSUE OF CLOGGING UP SO THEY ARE UNABLE TO PUSH THE MED THROUGH. THIS HAS CAUSED THE NURSING TO DO ANOTHER NEEDLE STICK IN ORDER TO HAVE THE INJECTION COMPLETED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12359910 ↗MalfunctionAug 23, 2021Complete Blockage
IT WAS REPORTED; "THE NURSES HAVE BEEN USING THIS SIZE FOR A CERTAIN INJECTION AND HAVE HAD THE ISSUE OF CLOGGING UP SO THEY ARE UNABLE TO PUSH THE MED THROUGH. THIS HAS CAUSED THE NURSING TO DO ANOTHER NEEDLE STICK IN ORDER TO HAVE THE INJECTION COMPLETED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12355593 ↗
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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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