Bag, Urine Collection, Leg, For External Use, Sterile
FDA adverse event reports and recall history for bag, urine collection, leg, for external use, sterile (product code FAQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 397
- Deaths
- 0
- Injuries
- 69
- Malfunctions
- 325
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
- 2024-09-30Open, ClassifiedLabeling mix-ups
Medline Leg bag, REF DYND12574
Undeclared latex
- 2024-09-30Open, ClassifiedLabeling mix-ups
Medline Leg bag, REF DYND12578
Undeclared latex
- 2024-09-30Open, ClassifiedLabeling mix-ups
Medline Leg bag, REF URO12573
Undeclared latex
- 2011-06-27TerminatedOther
RUSCH Urinary Drainage Bag, 2000 ml Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.
Sterile integrity cannot be guaranteed.
- 2011-06-27TerminatedOther
***** EXPANDED RECALL ***** Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter, Manufactured for and distributed by Teleflex Medical, Research Triangle Park, NC 57708 Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.
Sterile integrity cannot be guaranteed.
- 2003-05-22TerminatedOther
GENT-L-KARE STERILE MID-STREAM URINE COLLECTOR
Finished products were not sterilized.
- 2003-04-17TerminatedOther
Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.
There is a potential for package seals to be open after sterilization.
Monitor bag, urine collection, leg, for external use, sterile automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.