CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report

AART Calf Implant Calf Implant recalled by DSAART

Dsaart is recalling AART Calf Implant Calf Implant, distributed in 27 states. The recall was initiated on 26 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCalf 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

Quantity recalled35 implants

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0949-2026
FDA event ID: 97704
Recalling firm: Dsaart, Carson City, NV
Classification: Class II
Status: Ongoing
Recall initiated: 26 Sep 2025
FDA classified: 18 Dec 2025
Reported: 24 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Sep 2025	Recall initiated by company
18 Dec 2025	Classified by FDA	+83 days
24 Dec 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Kentucky Massachusetts Maryland Michigan Minnesota Mississippi Nebraska New Jersey New York Ohio Oklahoma

Questions about this recall

Why was it recalled?

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

Which lots 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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 97704

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025	CLASS II	AART Malar Implant Malar Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025	CLASS II	AART Silicone Carving Implant Silicone Carving Implant recalled	Dsaart	Other	27 states
24 Dec 2025	CLASS II	AART Chin Implant Chin Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025	CLASS II	AART Pectoral Implant Pectoral Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025	CLASS II	AART Gluteal Implant Gluteal Implant recalled by DSAART	Dsaart	Other	27 states

More recalls from Dsaart

All 6

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Device	CLASS II	AART Gluteal Implant Gluteal Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025Device	CLASS II	AART Pectoral Implant Pectoral Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025Device	CLASS II	AART Chin Implant Chin Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025Device	CLASS II	AART Silicone Carving Implant Silicone Carving Implant recalled	Dsaart	Other	27 states
24 Dec 2025Device	CLASS II	AART Malar Implant Malar Implant recalled by DSAART	Dsaart	Other	27 states

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide