The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0949-2026·Announced 2025-12-24

Calf implants recalled over specification deviations and missing premarket clearance

DSAART is recalling 35 AART Calf Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites a specification deviation and a premarket clearance shortfall with no stated consequence or reported harm.

Plain-English summary

AART Calf Implants from DSAART LLC are being recalled, covering catalog numbers including 502-103, 502-104 and 502-105 with their corresponding UDI-DI codes.

The recall follows manufactured products that deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances.

The record lists 35 implants, with lot numbers including 23-11-014, 24-07-016 and 25-04-018. Distribution covered Arkansas, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Kentucky, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington. The FDA has classified the action as Class II.

The record cites a specification deviation and a clearance shortfall without describing a consequence, and states no injuries. Facilities should follow the firm's instructions.

The recalled product

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…
Manufacturer
DSAART LLC
Category
Medical Device — Cosmetic implant
Hazard
Affected units
35

Distribution

Distributed in 27 states:

Part of a larger recall action

This product is one of 6 recalled by DSAART LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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