CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report
AART Pectoral Implant Pectoral Implant recalled by DSAART
Dsaart is recalling AART Pectoral Implant Pectoral 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
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-0948-2026
- 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 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 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6
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
ArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisKentuckyMassachusettsMarylandMichiganMinnesotaMississippiNebraskaNew JerseyNew YorkOhioOklahoma
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?
Pectoral Implant Model/Catalog Number: 500-106-5 UDI-DI code: B4905001065 Lot Number: 24-03-002 Model/Catalog Number: 500-106-6 UDI-DI code: B4905001066 Lot Number: 24-03-003 Model/Catalog Number: 500-200-5 UDI-DI code: B4905002005 Lot Numbers: 24-12-004 25-02-002 Model/Catalog Number: 500-200-6 UDI-DI code: B4905002006 Lot Numbers: 24-12-005 25-02-003 Model/Catalog Number: 500-201-5 UDI-DI code: B4905002015 Lot Numbers: 24-11-015 25-02-004 25-05-002 Model/Catalog Number: 500-201-6 UDI-DI code: B4905002016 Lot Numbers: 24-12-017 25-02-005 Model/Catalog Number: 500-202-5 UDI-DI code: B4905002025 Lot Numbers: 24-12-018 25-03-018 Model/Catalog Number: 500-202-6 UDI-DI code: B4905002026 Lot Numbers: 24-09-015 25-03-019 Model/Catalog Number: 500-403-5 UDI-DI code: B4905004035 Lot Number: 25-04-020 Model/Catalog Number: 500-403-6 UDI-DI code: B4905004036 Lot Number: 25-04-021
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 97704This product is part of a recall event; the main page for the event is AART Calf Implant Calf Implant recalled by DSAART.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AART Calf Implant Calf Implant recalled by DSAART | Dsaart | Other | 27 states | |
| CLASS II | AART Malar Implant Malar Implant recalled by DSAART | Dsaart | Other | 27 states | |
| CLASS II | AART Silicone Carving Implant Silicone Carving Implant recalled | Dsaart | Other | 27 states | |
| CLASS II | AART Chin Implant Chin Implant recalled by DSAART | Dsaart | Other | 27 states | |
| 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 |
|---|---|---|---|---|---|
| Device | CLASS II | AART Gluteal Implant Gluteal Implant recalled by DSAART | Dsaart | Other | 27 states |
| Device | CLASS II | AART Chin Implant Chin Implant recalled by DSAART | Dsaart | Other | 27 states |
| Device | CLASS II | AART Silicone Carving Implant Silicone Carving Implant recalled | Dsaart | Other | 27 states |
| Device | CLASS II | AART Malar Implant Malar Implant recalled by DSAART | Dsaart | Other | 27 states |
| Device | CLASS II | AART Calf Implant Calf Implant recalled by DSAART | Dsaart | Other | 27 states |
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| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |