C.R. Bard, Inc.
FDA adverse event reports naming C.R. Bard, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: C.R. BARD, INC..
- Total reports
- 3,341
- Deaths
- 18
- Injuries
- 2,368
- Malfunctions
- 811
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Mesh, Surgical, PolymericFTL1,196
- Catheter, UrologicalKOD304
- Agent, Bulking, Injectable For Gastro-Urology UseLNM233
- Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY205
- Catheter, Retention Type, BalloonEZL160
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally PlacedOTP123
- Port & Catheter, Implanted, Subcutaneous, IntravascularLJT93
- Catheter, Intravascular, DiagnosticDQO74
- Catheter, IrrigationGBX73
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN70
Recent recalls
- 2026-05-21Open, ClassifiedMaterial/Component Contamination
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
Due to stain present on the surface of affected foley catheters.
- 2025-12-11Open, ClassifiedUnder Investigation by firm
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 product label.
- 2025-12-11Open, ClassifiedUnder Investigation by firm
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- 2025-12-11Open, ClassifiedUnder Investigation by firm
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- 2025-12-11Open, ClassifiedUnder Investigation by firm
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- 2025-09-18Open, ClassifiedLabeling mix-ups
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
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 with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
- 2025-09-18Open, ClassifiedLabeling mix-ups
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
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 with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
- 2025-09-18Open, ClassifiedLabeling mix-ups
SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216
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 with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
- 2025-08-28Open, ClassifiedProcess design
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
- 2025-07-03Open, ClassifiedUnder Investigation by firm
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
Cather packaging may contain the incorrect French size.
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