CFAI
C.F.A.I.
Government Data Intelligence Services

CR BARD INC

Company NY
Found in 4 federal databases · 93 total records
EPA (Environmental Protection Agency) 2 records
EPA TRI: CR BARD INC
TRI facility in QUEENSBURY, NY (WARREN County)
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EPA TRI: CR BARD
TRI facility in MONCKS CORNER, SC (BERKELEY County)
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epa_echo 1 records
EPA ECHO: C.R. BARD 2007-05-24
Type: Administrative - Formal
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fda 89 records
FDA Recall: C.R. Bard Inc — Class I 20250528
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the ga | Product: Bard¿ Single Intragastric Linton Ballo...
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FDA Device Recall: BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 2025-12-17
Class II — Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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FDA Device Recall: Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 2025-12-17
Class II — Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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FDA Device Recall: BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit RE 2025-12-17
Class II — Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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FDA Device Recall: SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Cat 2025-09-24
Class II — Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel...
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FDA Device Recall: SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley 2025-09-24
Class II — Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel...
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FDA Device Recall: REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra 2025-07-09
Class II — Cather packaging may contain the incorrect French size.
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FDA Device Recall: BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr 2025-07-09
Class II — Cather packaging may contain the incorrect French size.
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FDA Device Recall: Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740 2025-05-28
Class I — Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
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FDA Device Recall: Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 2025-05-28
Class I — Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
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FDA Recall: C.R. Bard Inc — Class II 20240131
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, d | Product: Bard¿ Nasogastric Sump Tube with ENFit...
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FDA Recall: C.R. Bard Inc — Class II 20240131
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, d | Product: Bard¿ Nasogastric Sump Tube with PreVe...
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FDA Recall: C.R. Bard Inc — Class II 20240131
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, d | Product: Bard¿ Nasogastric Sump Tube with ENFit...
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FDA Recall: C.R. Bard Inc — Class II 20240131
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, d | Product: Bard¿ Nasogastric Sump Tube with PreVe...
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FDA Recall: C.R. Bard Inc — Class II 20240131
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, d | Product: Bard¿ Nasogastric Sump Tube and PreVen...
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FDA Device Recall: Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14F 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ wit 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000 2024-01-31
Class II — BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
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FDA Device Recall: HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) R 2023-06-14
Class II — Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impac...
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FDA Device Recall: Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, 2023-06-14
Class II — Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impac...
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FDA Device Recall: BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C 2022-03-02
Class II — There is a potential to leak from the catheter where it connects to the drain bag
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FDA Device Recall: BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C 2022-03-02
Class II — There is a potential to leak from the catheter where it connects to the drain bag
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FDA Recall: C.R. Bard Inc — Class II 20210929
There is potential for packaging defects that may impact the sterile barrier. | Product: Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sens
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FDA Recall: C.R. Bard Inc — Class II 20210929
There is potential for packaging defects that may impact the sterile barrier. | Product: Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
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FDA Recall: C.R. Bard Inc — Class II 20210929
There is potential for packaging defects that may impact the sterile barrier. | Product: Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
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FDA Device Recall: Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Met 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabi 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabili 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sen 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Mete 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage B 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Mete 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabil 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage B 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabil 2021-09-29
Class II — There is potential for packaging defects that may impact the sterile barrier.
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FDA Device Recall: Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urolog 2021-04-28
Class II — The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
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FDA Recall: C.R. Bard Inc — Class II 20200219
Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. | Product: The Bard Intra-abdominal Pressure Moni...
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FDA Device Recall: The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set 2020-02-19
Class II — Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed w...
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FDA Recall: C.R. Bard, Inc. — Class II 20180418
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. | Product: Bard(R) Premature Infant Feeding tube, ENFit(TM...
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FDA Device Recall: CritiCore Automated Urine Output and Temperature Monitor 2018-06-27
Class II — Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
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FDA Device Recall: Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. 2018-06-13
Class II — Foley Catheter with Incorrect Retainer Cap Print
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FDA Device Recall: Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usag 2018-04-18
Class II — BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
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FDA Device Recall: Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage 2018-04-18
Class II — BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
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FDA Device Recall: HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, ea 2018-04-11
Class II — Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
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FDA Device Recall: Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, eac 2018-04-11
Class II — Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
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FDA Device Recall: BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The 2018-02-07
Class II — The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies...
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FDA Device Recall: Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which 2017-12-27
Class II — Hydrogel peeling from the pads.
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FDA Device Recall: Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/b 2017-10-04
Class II — Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.
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FDA Device Recall: Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-1 2017-08-23
Class II — Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
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FDA Device Recall: BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tu 2017-08-16
Class II — Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
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FDA Device Recall: SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stab 2017-01-18
Class II — The product contained a latex catheter instead of a silicone catheter.
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FDA Recall: C.R. Bard, Inc. — Class II 20161221
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. | Product: BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap,...
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FDA Recall: C.R. Bard, Inc. — Class II 20161221
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. | Product: BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip...
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FDA Recall: C.R. Bard, Inc. — Class II 20161123
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is | Product: Totalis, RIGID and Totalis"I Flex ENDO...
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FDA Recall: C.R. Bard, Inc. — Class II 20160921
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile. | Product: Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
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FDA Device Recall: BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The 2016-12-21
Class II — Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
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FDA Device Recall: BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter 2016-12-21
Class II — Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
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FDA Device Recall: BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in 2016-12-21
Class II — Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
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FDA Device Recall: BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is a 2016-12-21
Class II — Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
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FDA Device Recall: Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covin 2016-11-23
Class II — Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal...
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FDA Device Recall: BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, 2016-11-23
Class II — Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal...
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FDA Device Recall: Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), St 2016-11-23
Class II — Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).
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FDA Device Recall: C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, 2016-11-23
Class II — Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
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FDA Device Recall: X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sh 2016-11-16
Class II — Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
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FDA Device Recall: Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only. 2016-09-21
Class II — During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
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FDA Device Recall: Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only. 2016-09-21
Class II — During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
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FDA Device Recall: BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladde 2016-04-20
Class II — Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
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FDA Device Recall: REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, 2016-02-24
Class III — Report by a customer of an open package seal.
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FDA Device Recall: Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling pa 2016-02-17
Class II — Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe...
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FDA Recall: C.R. Bard, Inc. — Class II 20150909
Potential breach of the sterile barrier packaging. | Product: Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 5061
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FDA Device Recall: Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude ti 2015-09-09
Class II — Potential breach of the sterile barrier packaging.
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FDA Device Recall: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30 2015-08-26
Class II — Potential breach of the sterile barrier packaging.
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FDA Device Recall: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Inse 2015-08-26
Class II — Potential breach of the sterile barrier packaging.
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FDA Device Recall: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30 2015-08-26
Class II — Potential breach of the sterile barrier packaging.
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FDA Device Recall: Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket i 2014-11-12
Class II — The product is non-sterile.
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ny_corps 1 records
NY Corp: C.R. BARD, INC. 1972-03-06
FOREIGN BUSINESS CORPORATION | County: Warren | Jurisdiction: New Jersey
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