Z-1293-2024Class II

EasyPoint Needle, 25G x 5/8", REF: 82091

Name: Z-1293-2024 EasyPoint Needle, 25G x 5/8", REF: 82091
Creator: Retractable Technologies, Inc.
Published: 2024-02-05
License: https://open.fda.gov/license/

Retractable Technologies, Inc. / initiated 2024-02-05 / Open, Classified / root cause: manufacturing process

FDA source

Retractable Technologies, Inc. began a recall of EasyPoint Needle, 25G x 5/8", REF: 82091 on 2024-02-05. FDA classified it as Class II and gives the reason as "The needle cannula of a retractable needle may detach from the needle holder in the patient". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1293-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-05
Posted: 2024-03-14
Recalling firm: Retractable Technologies, Inc.
Product: EasyPoint Needle, 25G x 5/8", REF: 82091
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: The needle cannula of a retractable needle may detach from the needle holder in the patient.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 2/5/24, recall notices were sent to customers and distributors who were asked to do the following: 1) Segregate, quarantine, and discontinue use and distribution of affected devices. 2) Inform all personnel who have received or are receiving affected devices that they should not use affected devices. 3) If affected product was further distributed, notify these additional customers immediately. When notifying customers include a copy of the recall notice, label images, and the response form. 4) Complete and return the response form to [email protected] Customers with additional questions can email the firm at [email protected]
Quantity in commerce: 477,600
Distribution: US Nationwide distribution including in the states of NY, FL, IL, MA, UT, NJ, AZ, MO, WA, NC, CA, TX, NV, IN, PA, VA, IA, GA, TN, MI, OH, OK, CO, OR, SC, MN, CT.
Product codes and lots: UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1293-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1293-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-14

Product code FMI

K133635Class IIEasypoint NeedleRetractable Technologies, Inc. / cleared 2014-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)