O.T.D Optimum Traction Device (Emergency Products) – Adhesive Failure (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Brand
Emergency Products & Research
Lot Codes / Batch Numbers
Model EP-800, Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1.
Products Sold
Model EP-800; Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1.
Emergency Products & Research is recalling O.T.D - Optimum Traction Device - Street Orange. Single use traction splint. due to Failure of adhesive to secure the pole insert.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure of adhesive to secure the pole insert.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026