Bard Access Systems, Inc.
FDA Regulatory Profile
Bard Access Systems, Inc. appears in FDA public data with 62 recalls — including 2 Class I (most serious) —, 22 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2656-2026, Class II) was initiated on May 21, 2026. Its most recent 510(k) clearance was granted on September 5, 2025.
Summary
- Total Recalls
- 62 (2 Class I)
- 510(k) Clearances
- 22
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2656-2026 | Class II | CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midl | May 21, 2026 |
| Z-2657-2026 | Class II | 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 | May 21, 2026 |
| Z-2661-2026 | Class II | 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI C | May 21, 2026 |
| Z-2662-2026 | Class II | CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidli | May 21, 2026 |
| Z-2659-2026 | Class II | 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Cathet | May 21, 2026 |
| Z-2665-2026 | Class II | 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Grosh | May 21, 2026 |
| Z-2663-2026 | Class II | CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidlin | May 21, 2026 |
| Z-2655-2026 | Class II | OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS | May 21, 2026 |
| Z-2664-2026 | Class II | CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 P | May 21, 2026 |
| Z-2660-2026 | Class II | 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801 | May 21, 2026 |
| Z-2667-2026 | Class II | CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Proven | May 21, 2026 |
| Z-2668-2026 | Class II | 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY | May 21, 2026 |
| Z-2666-2026 | Class II | 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO | May 21, 2026 |
| Z-2658-2026 | Class II | CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter st | May 21, 2026 |
| Z-1507-2025 | Class I | BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 317435 | March 11, 2025 |
| Z-1397-2022 | Class I | Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver | June 20, 2022 |
| Z-1991-2021 | Class II | 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyuret | May 19, 2021 |
| Z-1994-2021 | Class II | 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC | May 19, 2021 |
| Z-1661-2021 | Class II | REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit | April 7, 2021 |
| Z-1655-2021 | Class II | REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01 | April 7, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable | September 5, 2025 |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable P | June 18, 2025 |
| K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set | November 27, 2024 |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | October 31, 2024 |
| K240146 | BD Prevue II Peripheral Vascular Access System | February 18, 2024 |
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | November 10, 2022 |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | August 24, 2022 |
| K210264 | BD PowerPiCC Catheter | July 30, 2021 |
| K120882 | SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE | May 30, 2012 |
| K100402 | SITE-RITE VISION ULTRASOUND SYSTEM | March 5, 2010 |
| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | May 18, 2007 |
| K053589 | LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING | April 13, 2006 |
| K053501 | POWERPICC | January 13, 2006 |
| K051672 | POWERPICC | November 23, 2005 |
| K050310 | BARDPORT TITANIUM PORTS | April 18, 2005 |
| K042445 | SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT | October 19, 2004 |
| K971990 | GESCO PER-Q-CATH PICC CATHETERS | November 7, 1997 |
| K971991 | GESCO PER-Q-CATH MIDLINE CATHETERS | November 7, 1997 |
| K935380 | VASCULAR ACCESS CATHETER ACCESSORIES | February 17, 1995 |
| K926139 | CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH | January 3, 1995 |