Skip to content

Bard Access Systems, Inc.

Active in EUDAMED
Also registered as Bard Access Systems, Inc. (C.R. Bard, Inc.)

United Statesfrom SRN EUDAMED FDA SRN US-MF-000017720 FEI 3006260740

Bard Access Systems, Inc. is a medical device manufacturer based in the United States, with 4,383 devices listed and 123 FDA recalls as of 12 Nov 2026.

Devices
4,383
Registrations
EUDAMEDFDA
FDA recalls
12319 ongoing

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 2,983
  • EUDAMED 169

Among the 3,000 best-ranked of 4,383 devices.

Device classes
  • FDA Class II 2,886
  • FDA Class I 82
  • EU Class I 16
  • FDA Unclassified 11
  • EU Class IIa 5

Among the 3,000 best-ranked of 4,383 devices.

Top EMDN categories

Among the 3,000 best-ranked of 4,383 devices.

FDA recalls
Identifiers
  • EUDAMED SRN US-MF-000017720
  • FDA FEI 3006260740
  • DUNS 044611812

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls

What Bard Access Systems, Inc. makes

Bard Access Systems, Inc. manufactures peripherally-inserted central venous catheters, including midline and hemodialysis variants, as well as vascular port administration sets and catheters. Their portfolio also includes vascular intervention infusion catheters, wearable percutaneous catheter/tube holders, and electrocardiographic/magnetic navigation systems for central venous catheter placement. Additionally, they produce general-purpose ultrasound imaging systems and accessories for vascular port needle insertion.

The company’s devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Bard Access Systems, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4,383

Newest first, rows 1-50 of 4,383

Search and filter all 4,383 devices
Skip device list

  • PowerPICC® Provena™ Catheter CK000909B

    Listed Registry: GUDID Class:II

  • PowerPICC® Provena™ Catheter CK001006B

    Listed Registry: GUDID Class:II

  • PowerPICC SOLO2 Ref 6396335

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Power PICC Ref 6175108

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MicroEZ Ref 6688935

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Power PICC Solo2 Ref 6195118

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MicroEZ Ref 6128945

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • PowerPICC Ref 6386335

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Groshong Ref CK000516

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Power PICC Solo2 Ref 6195355

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Powerpicc Ref 66275208F

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • PowerPICC SOLO2 Ref CK000377

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Statlock Ref A7506196

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Groshong Ref 69655405

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • PowerPICC SOLO2 Ref 6396355

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Power PICC Ref 6175355

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Statlock Ref 8424640

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Site~rite Ref 9770503

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Powermidline Ref P6254208

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • PowerGlide Pro Ref 6F120080

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Powermidline Ref P6255208

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • PowerPICC Ref 66173335

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Statlock Ref CVNS004

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • PowerPICC Ref 6174118

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Power PICC Ref 6276335

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Power PICC Solo2 Ref 6295108

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Power PICC Solo2 Ref 66395335Q

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • PowerGroshong Ref 6918518

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Power PICC Solo2 Ref 66395355Q

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • PowerMidline Ref P6254118

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Powerpicc Solo Ref 66295355F

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • PowerPICC Ref 6275355

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • PowerGroshong Ref 6818508

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • PowerGroshong Ref 6918508

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Statlock Ref IVNS001

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • MicroEZ Ref 6828935

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Power PICC Solo2 Ref 6195335

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Statlock Ref 0705742

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Power PICC Ref 22185118

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • PowerPICC Ref 6396108

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Provena Ref S64244118

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • PowerPICC Ref 66173355

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Power PICC Ref 66375118Q

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • PowerGroshong Ref CK000517

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MicroEZ Ref 0668960

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • PowerMidline Ref P6255118

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • PowerGlide Pro Ref 6F122081

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Power PICC Solo2 Ref 6195108

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • PowerPICC Ref 66274208

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Provena Ref S64153208

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

Rows 1-50 of 4,383

Showing 1-50 of 4,383

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000017720
SRN (system / procedure pack)
US-PR-000017870
FDA FEI number
3006260740
DUNS number
044611812
EUDAMED status
Active
EUDAMED registered name
Bard Access Systems, Inc.
Registered address
605 North, 5600 West, 84116, Salt Lake City, United States
Website
No website
Phone
+1 801 230 5783
PRRC contact
Nitin Patil(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 6 Feb 2028

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 731186 Active Supplemented

    Quality management system EU MDR

    Issued
    2 Sep 2026
    Expires
    6 Feb 2028
    Reason
    Add device or group

FDA recalls123

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 93 recalls initiated by Bard Access Systems, Inc., the earliest on 2003-09-23 and the most recent on 2026-08-10. By recorded status: 19 ongoing and 74 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 2
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 20
  • 2022 1
  • 2023 0
  • 2024 0
  • 2025 1
  • 2026 17

82 initiated before 2017

Showing the 10 most recent of 123 recalls.

  • 2026

    • 10 Aug 2026 Z-2984-2026 Class I Ongoing this is a downstream recall of class I recall RES 98777 Distribution: US: FL, IL, OH, VA, MD, TX, WI, GA, TN, IN, SC, NC, MI, PA, OR, OK, AZ, MS, NJ, AL, CA, CO, MA, NV, ID, MO, LA, WA, KY,…
      Full distribution text US: FL, IL, OH, VA, MD, TX, WI, GA, TN, IN, SC, NC, MI, PA, OR, OK, AZ, MS, NJ, AL, CA, CO, MA, NV, ID, MO, LA, WA, KY, IA, NH, NY, KS, HI, NE, MN, MT, WY, AR, RI, WV, UT, PR, DE, CT, ME, DC, ND, NM, SD
      Submission numbers: K133456, K141531
    • 10 Aug 2026 Z-2985-2026 Class I Ongoing this is a downstream recall of class I recall RES 98777 Distribution: US: FL, IL, OH, VA, MD, TX, WI, GA, TN, IN, SC, NC, MI, PA, OR, OK, AZ, MS, NJ, AL, CA, CO, MA, NV, ID, MO, LA, WA, KY,…
      Full distribution text US: FL, IL, OH, VA, MD, TX, WI, GA, TN, IN, SC, NC, MI, PA, OR, OK, AZ, MS, NJ, AL, CA, CO, MA, NV, ID, MO, LA, WA, KY, IA, NH, NY, KS, HI, NE, MN, MT, WY, AR, RI, WV, UT, PR, DE, CT, ME, DC, ND, NM, SD
      Submission numbers: K030268, K090102
    • 30 Jul 2026 Z-2872-2026 Class I Ongoing After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy Distribution: US: MA, FL, IA, SC, IL, NY, UT, NJ, ID, IN, PA, CA, TX, OH, MO, VA, MD, NC, AL, MN, CO, KY, LA, NV, OK, MS, AZ, MI, GA,…
      Full distribution text US: MA, FL, IA, SC, IL, NY, UT, NJ, ID, IN, PA, CA, TX, OH, MO, VA, MD, NC, AL, MN, CO, KY, LA, NV, OK, MS, AZ, MI, GA, AR, KS, TN. OUS: CA, SG
      Submission numbers: K191976, K203193
    • 21 May 2026 Z-2655-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
    • 21 May 2026 Z-2656-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K001901
    • 21 May 2026 Z-2657-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K030268
    • 21 May 2026 Z-2658-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K091324
    • 21 May 2026 Z-2659-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K102159
    • 21 May 2026 Z-2660-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K133456
    • 21 May 2026 Z-2661-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K141531
Show the 25 most recent of 123 recalls

  • 2026

    • 21 May 2026 Z-2662-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K153393
    • 21 May 2026 Z-2663-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K162900
    • 21 May 2026 Z-2664-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K180548
    • 21 May 2026 Z-2665-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K201452
    • 21 May 2026 Z-2666-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K210264
    • 21 May 2026 Z-2667-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K213203
    • 21 May 2026 Z-2668-2026 Class II Ongoing Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
      Submission number: K813338

  • 2025

    • 11 Mar 2025 Z-1507-2025 Class I Ongoing Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy. Distribution: Worldwide - US Nationwide distribution including in the states of WI, NC, TX, NY, CA, MN, MT, RI, MA, OH, CT, SC, IL,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of WI, NC, TX, NY, CA, MN, MT, RI, MA, OH, CT, SC, IL, CO, VA, NJ, GA, UT, FL, PA, IN, MD, KY, AZ, MI, WA, HI, MO, VT, AL, NM, TN, DE, LA, IA, NH, ID, DC, WV, KS, NE, SD, ND, WY, AK, OK, OR, AR and the countries of Andorra, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, French Polynesia, French Guayana, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic of Korea, Reunion, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
      Submission number: K210264

  • 2022

    • 20 Jun 2022 Z-1397-2022 Class I Ongoing BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable. Distribution: Distribution US nationwide and Canada. Submission numbers: K203193, K191976

  • 2021

    • 19 May 2021 Z-1991-2021 Class II Terminated Catheter kits contained the incorrect micro-introducers. Distribution: U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None Submission number: K051672
    • 19 May 2021 Z-1994-2021 Class II Terminated Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire. Distribution: U.S. Nationwide distribution in the state of RI.
    • 7 Apr 2021 Z-1652-2021 Class II Terminated Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.
      Submission numbers: K063240, K201452
    • 7 Apr 2021 Z-1653-2021 Class II Terminated Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.
      Submission numbers: K063240, K201452
    • 7 Apr 2021 Z-1654-2021 Class II Terminated Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.
      Submission numbers: K063240, K201452
    • 7 Apr 2021 Z-1655-2021 Class II Terminated Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.
      Submission numbers: K063240, K201452

Frequently asked questions

How many devices does Bard Access Systems, Inc. have in the registry?

The registry currently lists 4383 devices for Bard Access Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bard Access Systems, Inc.'s devices?

Among its 50 most recently registered devices, Bard Access Systems, Inc. has devices listed in EUDAMED (48 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Bard Access Systems, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Bard Access Systems, Inc.'s devices are Class I, Class IIa, Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Bard Access Systems, Inc.?

FDA recall records list 123 recalls initiated by Bard Access Systems, Inc., the most recent initiated on 10 Aug 2026. 19 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Bard Access Systems, Inc.?

EUDAMED lists 1 certificate for Bard Access Systems, Inc. (quality management system) under MDR. The most recent was issued on 2 Sep 2026.

What are the newest devices from Bard Access Systems, Inc. in the registry?

The most recently registered devices listed for Bard Access Systems, Inc. include PowerPICC® Provena™ Catheter CK000909B, PowerPICC® Provena™ Catheter CK001006B, PowerPICC SOLO2 and Power PICC.

Generated automatically from registry data and not verified by a human reviewer.