--- title: "Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalo... — FDA record Z-0948-2026 | Is It on Recall" description: "Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clear" url: https://isitonrecall.com/recall/fda-device-z-0948-2026-brand-name-aart-pectoral-implant-product-name-pectoral-implant-model-catalog-number-500-106-5-pector/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant sty... — FDA record Z-0948-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Sep 26, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **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 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 - **Reason**: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. - **Classification**: Class II - **Recalling firm**: DSAART LLC - **Quantity**: 41 implants - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0948-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0948-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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 | Match all identifying details in the current notice. A brand name alone is not enough. ## 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 States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [District of Columbia](https://isitonrecall.com/state/district-of-columbia/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) ## Dates in the source - **Report date**: Dec 24, 2025 - **Recall initiation date**: Sep 26, 2025 - **Center classification date**: Dec 18, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0948-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [DSAART LLC records](https://isitonrecall.com/brand/dsaart-llc/)