C.R. Bard, Inc.

FDA Regulatory Profile

Summary

Total Recalls
116 (5 Class I)
510(k) Clearances
643
Inspections
22
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0907-2026Class IIBD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630November 6, 2025
Z-0906-2026Class IIBD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426November 6, 2025
Z-0908-2026Class IIBD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826November 6, 2025
Z-0905-2026Class IIBard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614November 6, 2025
Z-2590-2025Class IISureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: July 17, 2025
Z-2589-2025Class IISureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A30July 17, 2025
Z-2591-2025Class IISureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216July 17, 2025
Z-2462-2025Class IIBardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley CatheJune 18, 2025
Z-2075-2025Class IIBD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - June 3, 2025
Z-2076-2025Class IIREF: 123400,Bard Urologist's Tray, For the Obstructed UrethraJune 3, 2025
Z-2074-2025Class IIBD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr June 3, 2025
Z-1756-2025Class IBard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100April 17, 2025
Z-1755-2025Class IBard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" LengtApril 17, 2025
Z-1757-2025Class IBard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110April 17, 2025
Z-1758-2025Class IBard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300April 17, 2025
Z-1759-2025Class IBard¿ Single Intragastric Linton Balloon Tube, REF: 0092740April 17, 2025
Z-2154-2024Class IIBard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC CompMay 9, 2024
Z-0798-2024Class IIBard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN004December 20, 2023
Z-0805-2024Class IIBard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48inDecember 20, 2023
Z-0799-2024Class IIBard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN004December 20, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K251864Rubber Utility CatheterFebruary 23, 2026
K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)May 15, 2025
K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr.January 31, 2025
K230356Aspirex™ Thrombectomy SystemMarch 31, 2023
K223177Highlander™ 014 PTA Balloon Dilatation CatheterJanuary 20, 2023
K222793WavelinQ™ GeneratorOctober 17, 2022
K220270Aspirex Thrombectomy SystemJune 21, 2022
K213203Provena(TM) Midline CatheterMay 13, 2022
K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation CatheteMay 4, 2022
K212708Halo One Thin-Walled Guiding SheathSeptember 23, 2021
K211738Rotarex Atherectomy SystemSeptember 14, 2021
K203363Crosser iQ CTO Recanalization SystemAugust 12, 2021
K203575GlidePath Retro Long-Term Hemodialysis CatheterJuly 1, 2021
K201452Groshong NXT PICC CatheterMarch 12, 2021
K203275Recon Support CatheterMarch 1, 2021
K202150GlidePath 7.5F Long-Term Dialysis CatheterNovember 18, 2020
K2008183DMax MID Anatomical MeshJuly 17, 2020
K200627GlidePath 10F Long-Term Dialysis CatheterJune 22, 2020
K191532The Caterpillar and Caterpillar Micro Arterial Embolization DevicesFebruary 4, 2020
K192313Halo One Thin-Walled Guiding SheathDecember 19, 2019