Z-0949-2026Class II
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1...
Dsaart, LLC / initiated 2025-09-26 / Open, Classified / root cause: manufacturing process
DSAART LLC began a recall of 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... on . FDA classified it as Class II and gives the reason as "Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0949-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Dsaart, LLC
- 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 - 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
- Product code
- MIB Elastomer, Silicone Block
- Reason for recall
- Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
- Root cause tag
- manufacturing process
- FDA root cause
- No Marketing Application
- Action
- On 09/26/2025, the firm emailed a notice to an affected customer informing them that due to identified testing issues, the firm was requesting return of gluteal implants. On 11/17/2025, the firm send an "URGENT Medical Device removal of AART Silicone Implants" Letter to customer informing them that Alpha Aesthetics is voluntarily removing products as they conduct an analysis to determine the regulatory status of the devices. Customers are instructed to: 1. Either return the affected products that have not been implanted to Alpha Aesthetics at the company's expense, or discard affected products. 2. Acknowledge their actions via the enclosed "Medical Device Return Response" letter/form. For questions or further assistance with this removal, contact ** or email **.
- Quantity in commerce
- 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
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0944-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0945-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0946-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0947-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0948-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0949-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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