Retractable Technologies, Inc.: EasyPoint Needles Recalled for Risk of Needle Detachment During Use

Agency Publication Date: March 14, 2024

Summary

Retractable Technologies, Inc. is recalling approximately 477,600 EasyPoint Needles (25G x 5/8", REF: 82091) because the needle can detach from its holder while inside a patient. This defect occurs when the needle cannula separates from the needle holder during use, which may require medical intervention to retrieve the fragment. These needles were distributed nationwide across at least 27 states and were manufactured in the United States.

Risk

If the needle detaches while inside a patient, it may become a foreign object lodged in the body, which can cause internal tissue damage, infection, and potentially require surgery to remove.

What You Should Do

Check your medical supplies for EasyPoint Needles, 25G x 5/8", with REF number 82091.
Verify the lot information on the packaging: this recall specifically affects Lot K220402 with an expiration date of 03/28/2027 and UDI-DI 00613703820907.
Immediately stop using any needles identified from this affected lot.
Quarantine the products and contact Retractable Technologies, Inc. at their headquarters in Little Elm, Texas, for instructions on how to handle the affected inventory and to discuss potential refunds.
Patients who believe they have been treated with a defective needle should contact their healthcare provider immediately.
For additional information, contact the FDA at 1-888-463-6332 or visit the FDA medical device recall website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: EasyPoint Needle, 25G x 5/8"

Model / REF:

82091

Z-1293-2024

UPC Codes:

00613703820907

Lot Numbers:

K220402 (Exp 03/28/2027)

Date Ranges: 03/28/2027

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93981

Status: Active

Manufacturer: Retractable Technologies, Inc.

Sold By: Medical supply distributors

Manufactured In: United States

Units Affected: 477,600

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical supplies for EasyPoint Needles, 25G x 5/8", with REF number 82091.

Verify the lot information on the packaging: this recall specifically affects Lot K220402 with an expiration date of 03/28/2027 and UDI-DI 00613703820907.

Immediately stop using any needles identified from this affected lot.

Quarantine the products and contact Retractable Technologies, Inc. at their headquarters in Little Elm, Texas, for instructions on how to handle the affected inventory and to discuss potential refunds.

Patients who believe they have been treated with a defective needle should contact their healthcare provider immediately.

For additional information, contact the FDA at 1-888-463-6332 or visit the FDA medical device recall website at www.fda.gov/medical-devices/medical-device-recalls.