FDASeptember 3, 2024device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
trackx technologytrackx
UPCs
00857088008493
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCCombination Smoke and Carbon Monoxide (CO) Detectors Recalled Due to Risk of Serious Injury or Death from Failure to Alert Consumers to Fire; Sold Exclusively on Amazon.com by Treatlife Technology2026-06-25
- CPSCLuminous Fidget Spinner Balls Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by Anzmtosn2026-05-28
- CPSCSuperbobi Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Remy&shop2026-05-14
- CPSCTiyol Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violates Mandatory Standard for Toys; Sold on Amazon by ZW Creations2026-05-14
- CPSCLithium Coin Batteries Recalled Due?to Risk of Serious Injury or Death from Battery Ingestion; Violates Federal Statute for Child-Resistant Packaging of Coin Batteries; Imported and Sold on Amazon by LiCB2026-05-14
- CPSCEarthtec Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Tonyidea2026-04-30
- CPSCAdult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Imported by Hepo Care Medical Equipment Online2026-04-30
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