Exact FDA event identifier

Event 97704

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 26, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: DSAART LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs UDI-DI code: B4906006019 600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs UDI-DI code: B4906006039 600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs UDI-DI code: B4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs UDI-DI code: B49060060239 600-603 -Silicone Carving Implant Style 6 Size 3 UDI-DI code: B490600603 600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs UDI-DI code: B49060060339 600-604 - Silicone Carving Implant Style 6 Size 4 UDI-DI code: B490600604 600-605 - Silicone Carving Implant Style 6 Size 5 UDI-DI code: B490600605 600-801 - Silicone Carving Implant Style 8 Size 1 UDI-DI code: B490600801 600-803 - Silicone Carving Implant Style 8 Size 3 UDI-DI code: B490600803 600-804 - Silicone Carving Implant Style 8 Size 4 UDI-DI code: B490600804 Intended for Augmentation and reconstructive surgery. * Pending information

Z-0944-2026

Recall number: Z-0944-2026
Initiated: September 26, 2025
Classification: Class II
Status: Ongoing
Recalling firm: DSAART LLC
Quantity: 369 implants

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

AART Silicone Carving Implant Model/Catalog Number: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 Lot Numbers: 25-01-003 25-01-010 25-01-022 25-02-012 25-03-001 25-04-004 25-05-006 25-05-015 25-06-011 25-06-017 Model/Catalog Number: 600-602 UDI-DI code: B490600602 Lot Numbers: 25-02-006 25-02-021 25-03-007 25-04-005 25-05-017 25-06-015 Model/Catalog Number: 600-601-9 UDI-DI code: B4906006019 Lot Number: 25-02-017 Model/Catalog Number: 600-603-9 UDI-DI code: B4906006039 Lot Number: 25-02-026 Model/Catalog Number: 600-604-9 UDI-DI code: B4906006049 Lot Number: 25-02-018 Model/Catalog Number: 600-602-3-9 UDI-DI code: B49060060239 Lot Number: 24-04-011 Model/Catalog Number: 600-603 UDI-DI code: B490600603 Lot Numbers: 24-11-005 25-01-011 25-02-007 25-02-020 Model/Catalog Number: 600-603-3-9 UDI-DI code: B49060060339 Lot Number: 24-01-013 Model/Catalog Number: 600-604 UDI-DI code: B490600604 Lot Numbers: 24-10-013 25-01-012 25-02-024 25-04-012 Model/Catalog Number: 600-605 UDI-DI code: B490600605 Lot Numbers: 24-05-003 25-01-013 25-06-012 Model/Catalog Number: 600-801 UDI-DI code: B490600801 Lot Numbers: 24-11-017 25-01-004 25-01-014 25-01-023 25-07-009 Model/Catalog Number: 600-803 UDI-DI code: B490600803 Lot Numbers: 24-09-016 25-01-015 Model/Catalog Number: 600-804 UDI-DI code: B490600804 Lot Number: 23-10-005

Distribution pattern

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

device · product 2 of 6

Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-105 - Gluteal Implant style 1 size 5 UDI-DI code: B490501105 501-206 - Gluteal Implant style 2 size 6 UDI-DI code: B490501206 501-301 - Gluteal Implant style 3 size 1 UDI-DI code: B490501301 501-302 - Gluteal Implant style 3 size 2 UDI-DI code: B490501302 501-303 - Gluteal Implant style 3 size 3 UDI-DI code: B490501303 501-304 - Gluteal Implant style 3 size 4 UDI-DI code: B490501304 501-305 - Gluteal Implant style 3 size 5 UDI-DI code: B490501305 501-306 - Gluteal Implant style 3 size 6 UDI-DI code: B490501306 501-307 - Gluteal Implant style 3 size 7 UDI-DI code: B490501307 501-309 - Gluteal Implant style 3 size 9 UDI-DI code: B490501309 501-310 - Gluteal Implant style 3 size 10 UDI-DI code: B490501310

Z-0945-2026

Recall number: Z-0945-2026
Initiated: September 26, 2025
Classification: Class II
Status: Ongoing
Recalling firm: DSAART LLC
Quantity: 118 implants

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Gluteal Implant Model/Catalog Number: 501-101 UDI-DI code: B490501101 Lot Number: 24-01-030 Model/Catalog Number: 501-103 UDI-DI code: B490501103 Lot Numbers: 24-12-003 25-06-014 25-07-022 Model/Catalog Number: 501-105 UDI-DI code: B490501105 Lot Numbers: 24-07-012 24-09-013 Model/Catalog Number: 501-206 UDI-DI code: B490501206 Lot Number: 24-06-017 Model/Catalog Number: 501-301 UDI-DI code: B490501301 Lot Numbers: 23-10-020 25-01-021 Model/Catalog Number: 501-302 UDI-DI code: B490501302 Lot Numbers: 24-12-001 25-01-016 25-03-003 Model/Catalog Number: 501-303 UDI-DI code: B490501303 Lot Numbers: 24-10-004 24-11-001 25-01-017 25-02-011 25-03-003 25-04-009 Model/Catalog Number: 501-304 UDI-DI code: B490501304 Lot Numbers: 24-01-005 24-10-005 24-02-018 24-12-016 Model/Catalog Number: 501-305 UDI-DI code: B490501305 Lot Numbers: 24-09-009 25-01-001 25-03-004 25-04-010 Model/Catalog Number: 501-306 UDI-DI code: B490501306 Lot Numbers: 24-10-011 25-01-002 25-06-027 Model/Catalog Number: 501-307 UDI-DI code: B490501307 Lot Numbers: 24-09-010 24-12-002 25-04-007 Model/Catalog Number: 501-309 UDI-DI code: B490501309 Lot Number: 24-02-022 Model/Catalog Number: 501-310 UDI-DI code: B490501310 Lot Numbers: 24-10-010 25-02-009

Distribution pattern

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

device · product 3 of 6

Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 400-0201 Chin Implant style 2 size 1 UDI-DI code: B490400201 400-0202 Chin Implant style 2 size 2 UDI-DI code: B490400202 400-0301 Chin Implant style 3 size 1 UDI-DI code: B49044301 400-0302 Chin Implant style 3 size 2 UDI-DI code: B490400302

Z-0946-2026

Recall number: Z-0946-2026
Initiated: September 26, 2025
Classification: Class II
Status: Ongoing
Recalling firm: DSAART LLC
Quantity: 29 implants

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Chin Implant Model/Catalog Number: 400-0101 UDI-DI code: B490400101 Lot Number: 25-01-018 Model/Catalog Number: 400-0103 UDI-DI code:B490400103 Lot Numbers: 23-11-018 25-01-019 Model/Catalog Number: 400-0104 UDI-DI code: B490400104 Lot Number: 24-01-016 Model/Catalog Number: 400-0201 UDI-DI code: B409400201 Lot Number: 24-05-012 Model/Catalog Number: 400-0202 UDI-DI code: B490400202 Lot Number: 25-01-020 Model/Catalog Number: 400-0301 UDI-DI code: B490400301 Lot Numbers: 23-09-024 24-03-036 Model/Catalog Number: 400-0302 UDI-DI code: B490400302 Lot Number: 24-03-037

Distribution pattern

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

device · product 4 of 6

Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026

Z-0947-2026

Recall number: Z-0947-2026
Initiated: September 26, 2025
Classification: Class II
Status: Ongoing
Recalling firm: DSAART LLC
Quantity: 2 implants

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Malar Implant Model/Catalog Number: 401-202-5 UDI-DI code: B4904012025 Lot Number: 24-01-014 Model/Catalog Number: 401-202-6 UDI-DI code: B4904012026 Lot Number: 24-01-015

Distribution pattern

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

device · product 5 of 6

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

Z-0948-2026

Recall number: Z-0948-2026
Initiated: September 26, 2025
Classification: Class II
Status: Ongoing
Recalling firm: DSAART LLC
Quantity: 41 implants

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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

device · product 6 of 6

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

Z-0949-2026

Recall number: Z-0949-2026
Initiated: September 26, 2025
Classification: Class II
Status: Ongoing
Recalling firm: DSAART LLC
Quantity: 35 implants

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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