NAMIC 80087007Recalls & reported problems
Medline Industries, Inc. · SYRINGE 12ML TR/FR RA OEM · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 20193489066859), received between Dec 1, 2025 and Apr 2, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (11 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Feb 27, 2026Open, Classified
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1712-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Connection Problem11
- Loose or Intermittent Connection9
Patient problems
- No Clinical Signs, Symptoms or Conditions20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT, "THE SYRINGE TURNS ITSELF LOOSE WHILE INJECTING THE CONTRAST MEDIUM".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766501 ↗MalfunctionFeb 20, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408226 ↗MalfunctionFeb 20, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408136 ↗MalfunctionFeb 20, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24407681 ↗MalfunctionFeb 20, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405349 ↗MalfunctionFeb 20, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". AS A RESULT, THE FACILITY STATED THAT "OTHER SYRINGES USED FROM OWN STOCK". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404940 ↗MalfunctionFeb 20, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404871 ↗MalfunctionFeb 20, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404592 ↗MalfunctionFeb 20, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404385 ↗MalfunctionFeb 20, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403699 ↗MalfunctionFeb 20, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403324 ↗MalfunctionFeb 20, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT." AS A RESULT, THE FACILITY STATED THAT OTHER SYRINGES WERE USED FROM THEIR OWN STOCK. THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402662 ↗MalfunctionFeb 20, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402482 ↗MalfunctionFeb 20, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT." AS A RESULT, THE FACILITY STATED THAT OTHER SYRINGES WERE USED FROM THEIR OWN STOCK. THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402269 ↗MalfunctionFeb 20, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402018 ↗MalfunctionFeb 20, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401782 ↗MalfunctionFeb 20, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401196 ↗MalfunctionFeb 20, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400587 ↗MalfunctionFeb 19, 2026Connection Problem
IT WAS REPORTED THAT THE SYRINGE "DOESN'T TIGHTEN TO SEAL AND COME OFF AT TIGHTENING POINT". THE CUSTOMER DID NOT REPORT ANY INCIDENTS OF PATIENT INJURY RELATED TO THE REPORTED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24396993 ↗MalfunctionDec 1, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
THE SYRINGE DISCONNECTS FROM THE MANIFOLD WHEN CONNECTING FOR CONTRAST INJECTION OR FLUSHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687633 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.