Catheters, Suction, Tracheobronchial
FDA adverse event reports and recall history for catheters, suction, tracheobronchial (product code BSY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 3,453
- Deaths
- 42
- Injuries
- 350
- Malfunctions
- 2,931
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.
Recent recalls
- 2025-04-16Open, ClassifiedUnder Investigation by firm
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No
Lack of sterility assurance for closed suction catheter systems
- 2025-04-16Open, ClassifiedUnder Investigation by firm
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-16Open, ClassifiedUnder Investigation by firm
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-16Open, ClassifiedUnder Investigation by firm
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-16Open, ClassifiedUnder Investigation by firm
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-16Open, ClassifiedUnder Investigation by firm
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-16Open, ClassifiedUnder Investigation by firm
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2025-04-16Open, ClassifiedUnder Investigation by firm
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
Lack of sterility assurance for closed suction catheter systems
- 2024-09-06Open, ClassifiedUnder Investigation by firm
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- 2024-02-25Open, ClassifiedNonconforming Material/Component
MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Monitor catheters, suction, tracheobronchial automatically
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