Stop using nowMedical device recall · FDA · Published November 30, 2023
Busse Hospital Disposables Tracheostomy Care Set Recall: Risk of Infections
Busse Hospital Disposables recalls sterile tracheostomy care sets with specific catalog numbers due to potential infection risks from inadequate sterility assurance.
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
Take action
Contact the company
📍Recalling firmBusse Hospital Disposables, Inc.75 Arkay Dr · Hauppauge, NY 11788-3707
“Busse Hospital Disposables Tracheostomy Care Set Recall: Risk of Infections.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56717-busse-hospital-disposables-tracheostomy-care-set-recall-risk-of-infections. Based on FDA recall #Z-0594-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0594-2024%22&limit=1).
The FDA announced on November 30, 2023, that Busse Hospital Disposables is recalling Tracheostomy Care Sets due to sterility concerns. The agency issued recall number Z-0594-2024 for the voluntary Class I recall affecting 240 units distributed nationwide.
How to tell if you have it
Brand: Busse Hospital Disposables
Product: Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Lots: 2210087, 2210165, 2310361
Distribution: US Nationwide
The hazard
The recall covers kits containing Nurse Assist Sterile 0.9% Normal Saline for which the required sterility assurance level cannot be guaranteed. Risks include bloodstream, urinary tract, or respiratory infections, with potential outcomes of sepsis or death.
Context
GovInfoNow's records show Busse Hospital Disposables has two other recalls on file since February 22, 2022. On October 21, 2022, the company recalled a Joint Injection Tray because an adhesive liner could damage the product. On February 22, 2022, Busse issued a recall for Epidural Tray Catalog 1577 due to manufacturing validation concerns regarding drug products. Other recent recalls of similar products include Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (January 7, 2026), Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (January 7, 2026), and Medline Convenience Kits Recall: Risk of Contaminated Sterile Products (January 7, 2026).
How to tell if you have this one
Check for catalog numbers 9251R1, 9251R2, or 9251R3 on the tracheostomy care sets. The product was sold with specific lot numbers: 2210087, 2210165, and 2310361.
Brand
Busse Hospital Disposables
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0594-2024 (November 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0594-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
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