Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing. The affected products include lot numbers 2110053 and 2110115, representing 60 units distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II classification indicates potential for adverse health consequences, but this is a precautionary manufacturing process validation recall rather than a known product contamination or defect. The specific hazard is undefined, fitting the Moderate category for voluntary precautionary recalls.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI). The recall was initiated due to uncertainty about the adequacy of test method validation procedures used during manufacturing.
The affected kits are identified by lot numbers 2110053 and 2110115. A total of 60 units of these products were distributed nationwide.
The recalled product
- Product
- SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Hazard
- manufacturing-validation
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: Lot 2110053 2110115 UDI: 00849233005402
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27