Drug Swab Products Recalled for Manufacturing Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products made by PDI are being recalled due to uncertainty about validation testing adequacy in manufacturing. Users should discontinue use of affected lot numbers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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: This is an FDA Class II recall initiated due to manufacturing validation uncertainty with no reported illnesses or injuries. Per the rubric, recalls with theoretical hazards and no reported harm are classified as Moderate, consistent with voluntary precautionary recalls.
Plain-English summary
Busse Convenience kits containing swab/swabstick drug products, manufactured by Professional Disposables International (PDI), are subject to recall. The affected products have lot numbers 2031074, 2031227, 2130194, 2130535, and 2130783. The UDI for these products is 00849233016996.
The recall is due to uncertainty regarding the adequacy of validation of the test methods used to manufacture these drug products. This is a manufacturing quality issue related to the validation of testing procedures employed during production.
The products were distributed nationwide. Individuals and healthcare facilities using these products should cease use of any kits bearing the affected lot numbers.
The recalled product
- Product
- 3.2MM Pellet Insertion Tray Catalog Number: B7345R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Swabs/Swabsticks
- Hazard
- Affected units
- 250
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: 2031074 2031227 2130194 2130535 2130783 UDI: 00849233016996
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 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 58 products in this recall →Related recalls
Same manufacturer · Busse Hospital Disposables, Inc.
See all →- SevereDressing change tray recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- SevereTracheostomy care kits recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- SevereTracheostomy care sets recalled for sterility assurance failure
FDA (Devices) · 2024-01-10
- ModerateSurgical Injection Tray Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
- Moderate3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
Same hazard · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateMedical Device Swabs Recalled Due to Manufacturing Validation Uncertainty
FDA (Devices) · 2022-05-25
- ModerateMedline Convenience Kits with Polycarbonate Syringes Recalled
FDA (Devices) · 2026-04-29
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- ModerateMedline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-04-29
- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline Convenience Kits containing 10mL Polycarbonate Colored Syringes recalled
FDA (Devices) · 2026-04-29