FDA Device Recalls

Class IIOngoing

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

DSAART LLC

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

September 26, 2025 · DeviceView details →

LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis

SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube

SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube

LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.

CODMAN Disposable Perforator 9mm. Cranial Perforator.

SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004

AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.