Insight Base Flex (Trackx) – Incorrect Expiration Label (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to ha
Brand
Trackx Technology Inc
Lot Codes / Batch Numbers
GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027
Products Sold
GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027
Trackx Technology Inc is recalling Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that include due to The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the e. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected on the carton label and sterile pouch label correctly.
Recommended Action
Per FDA guidance
TrackX Technology issued an Urgent: Medical Device Field Correction notice to its consignees via hand delivery by their sales representatives on 10/01/2024. The notice explained the issue and requested that the notice be provided to all parties to whom the product was distributed. The sales representatives exchanged the affected product for correctly labeled product.
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 noticeDistribution
As reported by FDA
FL, NY, NC, PA, VA
Page updated: Jan 10, 2026