Tracheostomy care kits recalled for sterility assurance failure
Busse Hospital Disposables is recalling tracheostomy care kits containing Nurse Assist Sterile Normal Saline because the required sterility assurance level cannot be guaranteed. Contaminated products could cause serious infections including bloodstream, respiratory, and urinary tract infections, or sepsis.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The hazard includes risk of serious infections (bloodstream, respiratory, urinary tract) and potential sepsis or death, but no illnesses or deaths have been reported as already occurring.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling kits containing affected lots of Nurse Assist Sterile 0.9% Normal Saline. The recall affects 705 units distributed nationwide with the following lot numbers: 2210099, 2210135, 2210337, 2210377, 2310181, 2310233, and 2310291.
The manufacturer identified that the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed for these products. This means the products may not be adequately sterilized.
If contaminated products are used, patients could develop bloodstream infections, urinary tract infections, or respiratory infections. In the worst-case scenario, patients could develop sepsis or experience death.
The recalled product
- Product
- Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- sterility-failure
- bloodstream-infection
- respiratory-infection
- urinary-tract-infection
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePapablic Replacement Brush Heads Recalled Due to Breakage Risk
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- ModerateOrthofix MINIRAIL external fixation devices recalled for incorrect model labeling
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22