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C.R. Bard Inc FDA Recalls
71 recalls on file across devices, 5 of them Class I and 68 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 0080Class IIJun 25, 2026Due to complaints received indicating presence of contaminat |
| Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 9473Class IIJun 25, 2026Due to complaints received indicating presence of contaminat |
| Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801Class IIJun 25, 2026Due to complaints received indicating presence of contaminat |
| Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codClass IIJun 25, 2026Due to complaints received indicating presence of contaminat |
| Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A3003Class IIJun 25, 2026Due to complaints received indicating presence of contaminat |
| Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16CClass IIJun 25, 2026Due to complaints received indicating presence of contaminat |
| Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Class IIApr 23, 2026Due to stain present on the surface of affected foley cathet |
| BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426Class IINov 6, 2025Labeling discrepancy; Ureteral stent actual size may not mat |
| Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614Class IINov 6, 2025Labeling discrepancy; Ureteral stent actual size may not mat |
| BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630Class IINov 6, 2025Labeling discrepancy; Ureteral stent actual size may not mat |
| BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826Class IINov 6, 2025Labeling discrepancy; Ureteral stent actual size may not mat |
| SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316AClass IIJul 17, 2025Foley catheter trays have incorrect inserts, user may think: |
| SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414AClass IIJul 17, 2025Foley catheter trays have incorrect inserts, user may think: |
| SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216Class IIJul 17, 2025Foley catheter trays have incorrect inserts, user may think: |
| Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REFClass IIJun 18, 2025Foley catheter may have an obstructed lumen, which may resul |
| REF: 123400,Bard Urologist's Tray, For the Obstructed UrethraClass IIJun 3, 2025Cather packaging may contain the incorrect French size. |
| BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr Class IIJun 3, 2025Cather packaging may contain the incorrect French size. |
| BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316Class IIJun 3, 2025Cather packaging may contain the incorrect French size. |
| Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100Class IApr 17, 2025Due to customer complaints, there is a potential for users t |
| Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740Class IApr 17, 2025Due to customer complaints, there is a potential for users t |
| Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300Class IApr 17, 2025Due to customer complaints, there is a potential for users t |
| Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110Class IApr 17, 2025Due to customer complaints, there is a potential for users t |
| Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (2Class IApr 17, 2025Due to customer complaints, there is a potential for users t |
| Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Class IIMay 9, 2024Some of the devices may function incorrectly resulting in no |
| Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Lopez Valve¿ with ENFit, REF EN0056000Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Bard¿ Suction Connector with ENFit, REF EN0066000Class IIDec 20, 2023BD (C.R. Bard) has received user complaints reporting that d |
| Sensica Urine Output System, Catalog Number SCCS1002Class IINov 15, 2023BD (C.R. Bard) has received user complaints reporting that w |
| Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810GClass IIApr 20, 2023Some catheters had a manufacturing defect where the clear re |
| HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e)Class IIApr 20, 2023Some catheters had a manufacturing defect where the clear re |
| Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814Class IIApr 20, 2023Some catheters had a manufacturing defect where the clear re |
| Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 5081Class IIApr 20, 2023Some catheters had a manufacturing defect where the clear re |
| Sensica Urine Output SystemClass IIMay 19, 2022Complaints relating to urine output measurement accuracy. |
| BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14CClass IIJan 27, 2022There is a potential to leak from the catheter where it conn |
| BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16CClass IIJan 27, 2022There is a potential to leak from the catheter where it conn |
| Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization DevicClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" StabiClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter TrayClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter TrayClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" StaClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter TrayClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization DeviceClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" StClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine MeterClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter TrayClass IIAug 5, 2021There is potential for packaging defects that may impact the |
| Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological usClass IIJan 11, 2021The device catheter tip was cut off (no tip) and the product |