FDA recall, , Moderate risk
LinkBio CORE Workstation
The LinkBio CORE Workstation may display an incorrect planning date on the start case menu screen.
Summary by Recall Canary from the FDA notice
What happened
Linkbio Corp. of Rockaway, New Jersey, recalled 5 units of the Linkbio CORE Workstation, a component of the CORE Shoulder System, because the workstation may display an incorrect "Planning Date" when viewing cases on the "Start Case" menu screen. The recall began on March 12, 2026, and was added to the FDA's Enforcement Report on April 10, 2026.
The product was distributed in Alabama, Florida, and Kansas. The FDA classified the recall on April 10, 2026, and included it in the weekly enforcement report on April 22, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
LinkBio CORE Workstation, a component of the CORE Shoulder System.
- UDI-DI
- 00810022403099
- Product code
- 87-9136.
- Lot code
- All serial numbers of the CORE Workstation are affected.
Recall details
- Company began the recall
- Company
- Linkbio Corp.Rockaway, New Jersey
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98594
- Recall number
- Z-1810-2026
- Quantity recalled
- 5 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
