FDA Medical Device Recalls (openFDA)
Emergency Products & Research: O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
- Recall number
- Z-1395-2024
- Recalling firm
- Emergency Products & Research
- Product
- O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
- Status
- Open, Classified
- Initiated
- 2024-02-27
- Posted
- 2024-03-28
- Terminated
- not on file
- Reason
- Failure of adhesive to secure the pole insert.
- Root cause
- Process control
- Action
- Consignees were mailed an URGENT MEDICAL DEVICE RECALL notice, dated 2/27/24. The notice asked consignees who purchased product directly from the recalling firm to examine their inventory for affected devices, quarantine affected devices and discontinue use, and to follow the provided instructions for returning recalled product. Consignees who purchased their recalled devices through a third party are to examine their inventory for affected devices, quarantine affected devices and discontinue use, and contact the seller of the product to coordinate return. If a consignee is unsure of what third party a device was purchased from, they are to contact the recalling firm at 1-330-673-5003 or by email at EPRinfo@epandr.com. Customers may contact the recalling firm between the hours of 8:00 AM and 3:00 PM EST.
- Quantity
- 190,000 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, IL, IN, KS, MA, MI, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA.
- Lot, serial or model codes
- Model EP-800; Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HSP
- Firm FEI
- 3002754225
- Firm city
- Kent
- Firm state
- OH
- 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