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EasyPoint® 85291Recalls & reported problems

Retractable Technologies, Inc. · 25G x 5/8" EasyPoint® Needle · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613703852908), received between Jun 15, 2023 and Jun 15, 2023 — classified as 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (K133635); they may or may not involve this specific model.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Discomfort1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 15, 2023Adverse Event Without Identified Device or Use Problem

    PATIENT PRESENTED TO THE INFUSION CENTER FOR VIDAZA INJECTIONS. PATIENT REPORTS SIGNIFICANT PAIN/DISCOMFORT WITH OUR CURRENT NEEDLE SYSTEM. EASYPOINT NEEDLE: 25G X 5/8". RETRACTABLE TECHNOLOGIES INC LOT: K211201. PATIENT REQUESTS THAT NURSING REMOVE THE NEEDLE AND THEN DISENGAGE TO DECREASE THE PAIN.

    Patient problems: Discomfort; Pain

    MAUDE report 17134036 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133635. One submission often covers many models, so check the product and lot details in each record.

  • Z-1293-2024 · Feb 5, 2024 · Open, Classified
    EasyPoint Needle, 25G x 5/8", REF: 82091

Other Needle, Hypodermic, Single Lumen devices

All Needle, Hypodermic, Single Lumen devices →

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