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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 18 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202618
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. 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 ↗

Other Injector and syringe, angiographic devices

All Injector and syringe, angiographic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.