FDAClass IIDecember 24, 2025

Brand Name: AART Calf Implant Product Name: Calf recall

Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104…

Why was Brand Name: AART Calf Implant Product Name: Calf recalled?

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Calf Implant Model/Catalog Number: 502-103 UDI-DI code: B490502103 Lot Numbers: 23-11-014 24-07-016 25-04-018 Model/Catalog Number: 502-104 UDI-DI code: B490502104 Lot Numbers: 24-02-011 24-07-017 25-04-003 Model/Catalog Number: 502-105 UDI-DI code: B490502105 Lot Number: 24-05-019 Model/Catalog Number: 502-106 UDI-DI code: B490502106 Lot Numbers: 24-09-006 24-12-011 Model/Catalog Number: 502-201 UDI-DI code: B490502201 Lot Number: 24-01-001 Model/Catalog Number: 502-303 UDI-DI code: B490502303 Lot Number: 23-06-019 Model/Catalog Number: 502-304 UDI-DI code: B490502304 Lot Numbers: 24-12-013 25-03-005

Product
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104…
Recalling firm
DSAART LLC
Quantity
35 implants
Distribution
U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI O.U.S.: N/A
Recall date
December 24, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls