FDA Device Recalls

Class IIOngoing

1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155048 1174108D5 PowerPICC Catheter 4 Fr Singel-Lumen UDI-DI Code: 00801741155147 1194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741034510 1194108D1 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154782 1194108D4 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155093 1194108D5 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155192 1275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034558 1295108FD PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034626 3194108D PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741027727 3275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741027871 3295108D PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741028052 9194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035609 CK000267A PowerPICC SOLO2 Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741185021 CK000289C PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741161148 CK000293 PowerPICC HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741038020 CK000586B PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741212789 CK000613 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121395 CK000631B PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741143748 CK000632B PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741143755 CK000746A PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741227066 CK000886 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741188831 CK000966A PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741215858 CK000988 PowerPICCProvena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741216022 CK001006 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741219849 CK001030 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741223976 S1275108FD2 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-Di Code: 00801741154850 S1275108FD3 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741154959 S1295108FD1 PowerPICC Provena Catheter SOLO 5 Fr Dual-Lumen UDI-DI Code: 00801741154805 S1295108FD3 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155017 S1295108FD5 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155215 S1385108D PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112720 S1385108D2 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154867 S1385108D3 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154966 S1385108D4 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155079 S1395108D PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112751 S1395108D1 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154812 S1395108D2 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154911 S1395108D3 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155024 S1395108D4 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155123 S1395108D5 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155222

Bard Access Systems, Inc.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

May 21, 2026 · DeviceView details →

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).

Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350

Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325

CRE Wireguided 10-12mm 240cm

CRE Pro Wireguided 18-20mm 240cm

Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A

RayCare 2024A SP1. Oncology Information Systems.

Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A

Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

RayCare 2024A SP4. Oncology Information Systems.

ARTIS icono floor. Model Number: 11327700.

Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444