Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Recalled by DSAART LLC Due to Due to manufactured products that deviated from established...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DSAART LLC directly.
Affected Products
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 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105 502-106 - Calf Implant style 1 size 6 UDI-DI code: B490502106 502-201 - Calf Implant style 2 size 1 UDI-DI code: B490502201 502-303 - Calf Implant style 3 size 3 UDI-DI code: B490502303 502-304 - Calf Implant style 3 size 4 UDI-DI code: B490502304
Quantity: 35 implants
Why Was This Recalled?
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Where Was This Sold?
This product was distributed to 26 states: AZ, AR, CA, CO, CT, FL, GA, IL, KY, MD, MA, MI, MN, MS, NE, NJ, NY, OH, OK, PA, TX, UT, VA, WA, WI, DC
About DSAART LLC
DSAART LLC has 6 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report