C.R. Bard Inc

Complete recall history across all FDA and CPSC categories — 65 total recalls

C.R. Bard Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (65)

FDA medical device enforcement actions by C.R. Bard Inc. Showing most recent 50.

Date Product Reason Class
Nov 6, 2025 BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit R... Labeling discrepancy; Ureteral stent actual size may not match the actual pr... Class II
Nov 6, 2025 BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit ... Labeling discrepancy; Ureteral stent actual size may not match the actual pr... Class II
Nov 6, 2025 Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 Labeling discrepancy; Ureteral stent actual size may not match the actual pr... Class II
Nov 6, 2025 BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit R... Labeling discrepancy; Ureteral stent actual size may not match the actual pr... Class II
Jul 17, 2025 SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216 Foley catheter trays have incorrect inserts, user may think:1)Silicone, when ... Class II
Jul 17, 2025 SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Fol... Foley catheter trays have incorrect inserts, user may think:1)Silicone, when ... Class II
Jul 17, 2025 SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley ... Foley catheter trays have incorrect inserts, user may think:1)Silicone, when ... Class II
Jun 18, 2025 Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated A... Foley catheter may have an obstructed lumen, which may result in an inability... Class II
Jun 3, 2025 BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr... Cather packaging may contain the incorrect French size. Class II
Jun 3, 2025 BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 1... Cather packaging may contain the incorrect French size. Class II
Jun 3, 2025 REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra Cather packaging may contain the incorrect French size. Class II
Apr 17, 2025 Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 Due to customer complaints, there is a potential for users to be unable to or... Class I
Apr 17, 2025 Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. ... Due to customer complaints, there is a potential for users to be unable to or... Class I
Apr 17, 2025 Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 Due to customer complaints, there is a potential for users to be unable to or... Class I
Apr 17, 2025 Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 Due to customer complaints, there is a potential for users to be unable to or... Class I
Apr 17, 2025 Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740 Due to customer complaints, there is a potential for users to be unable to or... Class I
May 9, 2024 Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard... Some of the devices may function incorrectly resulting in no temperature disp... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120 BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160 BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ... BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Suction Connector with ENFit, REF EN0066000 BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000 BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr... BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr... BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12F... BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ... BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr... BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180 BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr... BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140 BD (C.R. Bard) has received user complaints reporting that during use of BD B... Class II
Nov 15, 2023 Sensica Urine Output System, Catalog Number SCCS1002 BD (C.R. Bard) has received user complaints reporting that when the device wa... Class II
Apr 20, 2023 Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G... Some catheters had a manufacturing defect where the clear resealing label sep... Class II
Apr 20, 2023 Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 5... Some catheters had a manufacturing defect where the clear resealing label sep... Class II
Apr 20, 2023 Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 5180... Some catheters had a manufacturing defect where the clear resealing label sep... Class II
Apr 20, 2023 HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b... Some catheters had a manufacturing defect where the clear resealing label sep... Class II
May 19, 2022 Sensica Urine Output System Complaints relating to urine output measurement accuracy. Class II
Jan 27, 2022 BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C There is a potential to leak from the catheter where it connects to the drain... Class II
Jan 27, 2022 BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C There is a potential to leak from the catheter where it connects to the drain... Class II
Aug 5, 2021 Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabi... There is potential for packaging defects that may impact the sterile barrier. Class II
Aug 5, 2021 Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II
Aug 5, 2021 Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage... There is potential for packaging defects that may impact the sterile barrier. Class II
Aug 5, 2021 Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing... There is potential for packaging defects that may impact the sterile barrier. Class II
Aug 5, 2021 Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing ... There is potential for packaging defects that may impact the sterile barrier. Class II
Aug 5, 2021 Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... There is potential for packaging defects that may impact the sterile barrier. Class II
Aug 5, 2021 Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II
Aug 5, 2021 Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II

View all 65 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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