Dressing change tray recalled for sterility assurance failure
Busse Hospital Disposables recalls sterile dressing change trays due to inability to guarantee required sterility assurance level. The defect could lead to serious infections including blood stream, urinary tract, or respiratory infections.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall for confirmed sterility failure that cannot meet required assurance levels. The non-sterile medical device poses documented risk of serious patient infections including blood stream infections, urinary tract infections, respiratory infections, and potentially sepsis or death.
Plain-English summary
Busse Hospital Disposables is recalling its Catalog No. 1443 Dressing Change Tray (Sterile, Latex Free) due to failure to guarantee the required sterility assurance level. The recall includes 536 units distributed nationwide, specifically lots 2210077, 2210112, 2310275, and 2310331 (UDI-DI 00849233010727).
The recalled kits contain Nurse Assist Sterile 0.9% Normal Saline. The firm determined that the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed for these lots. Failure to meet this sterility standard is classified as an FDA Class I recall.
If used, the non-sterile product poses risks to patients, including blood stream infections, urinary tract infections, or respiratory infections. In the worst-case scenario, there is risk of sepsis or death.
The recalled product
- Product
- Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
- Manufacturer
- Busse Hospital Disposables, Inc.
- Affected units
- 536
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00849233010727 Lots 2210077 2210112 2310275 2310331
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Busse Hospital Disposables, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Busse Hospital Disposables, Inc.
See all →- SevereTracheostomy care sets recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- SevereTracheostomy care kits recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- Moderate3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
- ModerateSurgical Injection Tray Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
- ModerateProcedure Tray Recalled for Manufacturing Test Method Validation Uncertainty
FDA (Devices) · 2022-06-08
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighSterile Epidural Tray Recalled Due to Validation Uncertainty
FDA (Devices) · 2022-06-08
- ModerateStereo Breast Biopsy Tray Recalled for Manufacturing Test Validation Uncertainty
FDA (Devices) · 2022-06-08
- SevereMedline Tracheal Care Trays Recalled Due to Sterility Concerns
FDA (Devices) · 2024-03-06
- CriticalMedline wound care trays recalled due to sterility defect
FDA (Devices) · 2024-03-06
- SevereMedline Laceration Trays Recalled Due to Sterility Defect
FDA (Devices) · 2024-03-06
- ModerateCervical Tray Recalled for Manufacturing Test Method Validation Uncertainty
FDA (Devices) · 2022-06-08