Bard Access Systems, Inc. FDA Recalls

39 recalls on file across devices, 5 of them Class I and 19 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625Class IAug 10, 2026this is a downstream recall of class I recall RES 98777	this is a downstream recall of class I recall RES 98777	Class IDevices	Aug 10, 2026
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis CathClass IAug 10, 2026this is a downstream recall of class I recall RES 98777	this is a downstream recall of class I recall RES 98777	Class IDevices	Aug 10, 2026
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D01525Class IJul 30, 2026After placement of intraosseous (IO) needle sets, used when	After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to o	Class IDevices	Jul 30, 2026
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 Class IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena CatClass IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 01108Class IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-LumenClass IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC providClass IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internClass IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended uClass IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3Class IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDIClass IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-LClass IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240Class IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr DualClass IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr SiClass IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr SinClass IIMay 21, 2026Due to lidocaine ampoules being manufactured under deficient	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain	Class IIDevices	May 21, 2026
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118Class IMar 11, 2025Catheters indicated for short-or-long term access to the cen	Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt	Class IDevices	Mar 11, 2025
Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D0151Class IJun 20, 2022BD Intraosseous Needle Kits may exhibit: 1) Increased force	BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous ne	Class IDevices	Jun 20, 2022
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC Class IIMay 19, 2021Catheter kits contained the incorrect micro-introducers.	Catheter kits contained the incorrect micro-introducers.	Class IIDevices	May 19, 2021
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARDClass IIMay 19, 2021Catheter convenience kits contain the incorrect guidewire. K	Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contain	Class IIDevices	May 19, 2021
REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen,Class IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, SingleClass IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage:Class IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, Class IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage:Class IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, Class IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product UsageClass IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - PrClass IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-LumenClass IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product UsagClass IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, SClass IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, SiClass IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen,Class IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen,Class IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UClass IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product UsagClass IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage:Class IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021
REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - ProducClass IIApr 7, 2021Catheters contain two issues: 1. the inner diameter of the d	Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inabil	Class IIDevices	Apr 7, 2021