FDA recall record · openFDA
C.R. Bard Inc
40 FDA recalls on record (2023–2026) — 40 device. 40 still ongoing.
5
Class I (most serious)
35
Class II
0
Class III
40
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, in 17
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic pl 5
Labeling discrepancy; Ureteral stent actual size may not match the actual product label. 4
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, result 4
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rub 3
Recalls
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740 Class I 2025-04-17 Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 Class I 2025-04-17 Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 Class I 2025-04-17 Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (2 Class I 2025-04-17 Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 Class I 2025-04-17 Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Class II 2026-04-23 SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A Class II 2025-07-17 BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630 Class II 2025-11-06 SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A Class II 2025-07-17 REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra Class II 2025-06-03 Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 Class II 2025-11-06 BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426 Class II 2025-11-06 BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr Class II 2025-06-03 BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316 Class II 2025-06-03 SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216 Class II 2025-07-17 Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF Class II 2025-06-18 BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826 Class II 2025-11-06 Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Class II 2024-05-09 Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140 Class II 2023-12-20 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180 Class II 2023-12-20 Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180 Class II 2023-12-20 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140 Class II 2023-12-20 Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140 Class II 2023-12-20 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120 Class II 2023-12-20 HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) Class II 2023-04-20 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100 Class II 2023-12-20 Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 Class II 2023-12-20 Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814 Class II 2023-04-20 Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180 Class II 2023-12-20 Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160 Class II 2023-12-20 Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000 Class II 2023-12-20 Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 Class II 2023-12-20 Bard¿ Suction Connector with ENFit, REF EN0066000 Class II 2023-12-20 Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G Class II 2023-04-20 Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 5081 Class II 2023-04-20 Sensica Urine Output System, Catalog Number SCCS1002 Class II 2023-11-15 Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120 Class II 2023-12-20 Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160 Class II 2023-12-20 Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160 Class II 2023-12-20 Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120 Class II 2023-12-20
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.