Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall with no reported illnesses or injuries. The hazard is manufacturing test validation uncertainty rather than a confirmed defect. Per the severity rubric, it qualifies as a risk-of-harm product where injury has not been reported, meeting the criteria for High severity.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Busse Convenience kits that contain swab and swabstick products manufactured by Professional Disposables International (PDI). The recalled products are distributed nationwide. Affected lot numbers are 2110127 and 2110269, representing 60 units.
The U.S. Food and Drug Administration (FDA) issued this Class II recall due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture the drug products. The specific nature of the manufacturing validation deficiency has not been detailed in the recall notice.
The recalled product
- Product
- SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- manufacturing-defect
- validation-failure
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)
- Lot Numbers: 2110127 2110269 UDI: 00849233006515
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03