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Bard Access Systems

Bard Access Systems Recalls

All product recalls associated with Bard Access Systems.

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Recall Summary

Total Recalls

249

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 181–200 of 249 recalls

Bard Access Systems: BD Posiflush Saline Flush Syringe 10 ml inlcuded in the f...

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

Class IIModerate

FDAAug 8, 2014Nationwide• Bard Access Systems

PACCAR WARNING TRIANGLE KITS Equipment Recall: EQUIPMENT

PACCAR Parts (PACCAR), a division of PACCAR Incorporated, is recalling certain aftermarket Mirrex and TRP-branded Warning Triangle kits, sold June 1, 2009, to July 2, 2014, as Paccar part numbers GMX1005K and MD1005K. The affected warning triangle kits do not have the manufacturer's name permanently marked on each triangle in the kit. As such, these Warning Triangle kits fail to comply with the requirements of Federal Motor Vehicle Safety Standard No. 125, "Warning devices."

NHTSAJul 14, 2014Nationwide• PACCAR

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E-Z-HD Barium Sulfate (Bracco) – Subpotent Drug Concerns (2014)

Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

Class IIILow

FDAJul 2, 2014Nationwide• Bracco Diagnostic Inc

VoLumen Barium Suspension (Bracco) – Preservative Issue (2013)

Failed Stability Testing: This product is below specification for preservative content.

Class IIILow

FDADec 16, 2013Nationwide• Bracco Diagnostics Inc

Tagitol V Barium Sulfate (Bracco) – Failed Stability Test (2013)

Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.

Class IIILow

FDAJul 19, 2013Nationwide• Bracco Diagnostics Inc

Gastrografin (Bracco Diagnostics) – Foreign Substance Risk (2013)

Presence of foreign substance: One lot of the product may contain black foreign particles

Class IIModerate

FDAJun 21, 2013Nationwide• Bracco Diagnostics Inc

Isovue-370 Injection (Bracco) – particulate matter (2012)

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Class IHigh

FDANov 21, 2012Nationwide• Bracco Diagnostic Inc

Isovue-300 Injection (Bracco) – particulate matter (2012)

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Class IHigh

FDANov 21, 2012Nationwide• Bracco Diagnostic Inc

Residential Elevators (ThyssenKrupp) – Fall Hazard (2012)

This recall involves LEV II, Volant and Rise residential elevators. The elevators were installed in residences with three or more floors. The elevator's four-digit model number is part of the longer serial number. Model numbers included in this recall are "RLWL" for the LEV II, "RLGL" for the Volant and "RLRC" for the Rise. The model/serial number is printed in the owner's manual and at the top of the elevator's controller, which is mounted at the top of the elevator in the hoistway or shaft.

CPSCSep 20, 2012Nationwide• ThyssenKrupp Access Manufacturing LLC, of Roanoke, Ill.

Choletec Kit (Bracco) – Particulate Matter Risk (2012)

Presence of Particulate Matter; potential for charcoal particulates

Class IIILow

FDAAug 14, 2012Nationwide• Bracco Diagnostic Inc

Cardiogen-82 (Bracco Diagnostics) – Sr-82 level deviation (2012)

GMP deviation; Sr-82 levels exceeded alert limit specification

Class IIModerate

FDAJun 1, 2012Nationwide• Bracco Diagnostics Inc

Multihance Injection (Bracco) – Sterility Concern (2012)

Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.

Class IIModerate

FDAApr 16, 2012Nationwide• Bracco Diagnostics Inc

Multihance Injection (Bracco) – Short Fill Potential (2012)

Short Fill: The product is being recalled due to a potential underfill of the affected vials.

Class IIILow

FDAApr 16, 2012Nationwide• Bracco Diagnostics Inc

ACC EXT-003 Equipment Recall: EQUIPMENT:MOTORCYCLE:HELMETS

ADVANCED CARBON COMPOSITES (ACC) IS RECALLING ALL MODEL EXT-001, EXT-002, AND EXT-003 MOTORCYCLE HELMETS, SIZES S/M, M/L, AND L/XL. THESE HELMETS FAIL TO CONFORM TO THE PENETRATION, IMPACT ATTENUATION, AND/OR LABELING REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 218, "MOTORCYCLE HELMETS."

NHTSAApr 23, 2010Nationwide• ACC

ACC EXT-004 Equipment Recall: EQUIPMENT:MOTORCYCLE:HELMETS

ADVANCED CARBON COMPOSITES (ACC) IS RECALLING ALL MODEL EXT-004 MOTORCYCLE HELMETS, SIZES S/M, M/L, AND L/XL. THESE HELMETS FAIL TO CONFORM TO THE PENETRATION REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 218, "MOTORCYCLE HELMETS."

NHTSAApr 16, 2010Nationwide• ACC

ACCC AMERICAN PROSPECTOR SUV Tire Recall: TIRES:TREAD/BELT

AMERICAN CAR CARE CENTER HAS NOTIFIED NHTSA ABOUT A NONCOMPLIANCE IN CERTAIN AMERICAN PROSPECTOR SUV TIRES, SIZE 245/70R17, PRODUCED BETWEEN NOVEMBER 15 AND NOVEMBER 21, 2009. THESE TIRES FAIL TO CONFORM TO THE REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 139, "NEW PNEUMATIC RADIAL TIRES FOR LIGHT VEHICLES." AT VARIOUS MILEAGES, THE SUBJECT TIRES MAY DEVELOP AND EXHIBIT TREAD CHUNKING OR CRACKING IN THE TREAD SHOULDER AREA.

NHTSAMar 9, 2010Nationwide• ACCC

Accuray Inc: CyberKnife Treatment Planning System, a subsystem of the ...

If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment.

FDADec 29, 2009Nationwide• Accuray Inc

Accuray Inc: RoboCouch Patient Support System, model number 025007, a ...

Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.

FDAJul 21, 2009AL, CA, CT +8 more• Accuray Inc

Accuray Inc: CyberKnife Treatment Delivery System, a subsystem of the ...

Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.

FDAJun 22, 2009AL, CA, CO +21 more• Accuray Inc

Accuray Inc: CyberKnife System Robotic Radiosurgery System, (Standard ...

The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.

FDAMar 16, 2009Nationwide• Accuray Inc