Surgical tracking device patient labels show incorrect expiration date
Patient label stickers on Insight Base Flex tracking device snaps have incorrect expiration dates. The stickers show manufacturing date instead of actual expiration date, though the correct date appears on carton and pouch labels.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with minor labeling error: patient label stickers show incorrect expiration date (manufacturing date instead of actual date). Correct dates appear on carton and sterile pouch labels. No illnesses or injuries reported.
Plain-English summary
Trackx Technology Inc is recalling Insight Base Flex - 8 (Ref 608-3TX) surgical instrument tracking device snaps because patient label stickers contain incorrect expiration dates. The contract manufacturer mistakenly recorded the manufacturing date (April 1, 2024) as the expiration date instead of the actual expiration date (April 1, 2027). However, the correct expiration date is properly displayed on the carton label and sterile pouch label.
The recall affects 82 units with GTIN 00857088008493, Lot 2404002 distributed in North Carolina, Virginia, Florida, Pennsylvania, and New York.
Consumers and healthcare providers who have received these devices should verify the expiration date by checking the carton or sterile pouch label rather than relying on the patient label sticker. Contact Trackx Technology Inc if you have questions about your device.
The recalled product
- 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…
- Manufacturer
- Trackx Technology Inc
- Hazard
- Affected units
- 82
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN: 00857088008493
- Lot: 2404002
- Expiration Date: 04/01/2027
Distribution
Related recalls
Same manufacturer · Trackx Technology Inc
See all →- HighSurgical instrument tracker recalled for structural failure during use
FDA (Devices) · 2023-02-15
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- HighSurgical instrument tracker recalled for structural failure during use
FDA (Devices) · 2023-02-15
- HighIrix-A Lumbar Fusion Implants Recalled for Incorrect Expiration Dates
FDA (Devices) · 2025-02-26
- LowTeleflex Recalls RUSCH Foley Urinary Catheter Insertion Trays Due to Labeling Error
FDA (Devices) · 2014-08-13
- HighStryker Recalls Mislabeled Intracardiac Ultrasound Catheters Due to Expiration Date Error
FDA (Devices) · 2021-02-03
- ModerateBaxter EXACTAMIX Inlets Recalled for Incorrect Labeling
FDA (Devices) · 2018-05-30
- ModerateQuest Medical Recalls Lacrimal Intubation Sets Due to Labeling Error
FDA (Devices) · 2015-04-08