EasyPoint recallZ-1293-2024 · Retractable Technologies, Inc. · initiated Feb 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Retractable Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The needle cannula of a retractable needle may detach from the needle holder in the patient.
FDA root cause category: Process control
What the company is doing
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]
Recall details
- Recall number
- Z-1293-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 5, 2024
- Posted by the FDA
- Mar 14, 2024
- Recalling firm
- Retractable Technologies, Inc.
- Quantity
- 477,600
- Product code
- FMI
- FDA submissions
- K133635
- 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 description
EasyPoint Needle, 25G x 5/8", REF: 82091
Code information (models, lots, serial numbers)
UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EasyPoint® 82091Retractable Technologies, Inc. · Needle, Hypodermic, Single Lumen1 recall15 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K133635 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- EasyPoint® 82011Retractable Technologies, Inc. · Needle, Hypodermic, Single Lumen2 reports
- EasyPoint® 85291Retractable Technologies, Inc. · Needle, Hypodermic, Single Lumen1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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