FDA Medical Device Recalls (openFDA)
Retractable Technologies, Inc.: EasyPoint Needle, 25G x 5/8", REF: 82091
- Recall number
- Z-1293-2024
- Recalling firm
- Retractable Technologies, Inc.
- Product
- EasyPoint Needle, 25G x 5/8", REF: 82091
- Status
- Open, Classified
- Initiated
- 2024-02-05
- Posted
- 2024-03-14
- Terminated
- not on file
- Reason
- The needle cannula of a retractable needle may detach from the needle holder in the patient.
- 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 rtiservice@retractable.com Customers with additional questions can email the firm at regulatory@retractable.com
- Quantity
- 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.
- Lot, serial or model codes
- UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027
- 510(k) numbers
- ["K133635"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 1000306068
- Firm city
- Little Elm
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28