The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0948-2026·Announced 2025-12-24

Pectoral implants recalled over specification deviations and missing premarket clearance

DSAART is recalling 41 AART Pectoral 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 Pectoral Implants from DSAART LLC are being recalled, covering catalog numbers including 500-106-5 (style 1 size 6 left) and 500-106-6 (style 1 size 6 right) 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 41 implants, including lot number 24-03-002. 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 Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2…
Manufacturer
DSAART LLC
Category
Medical Device — Cosmetic implant
Hazard
Affected units
41

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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