Core Biopsy Tray Recall Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.
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: FDA Class II recall with no reported injuries or illnesses. The hazard is theoretical—a manufacturing process validation issue that creates risk of undiscovered device defects. Per the rubric, a risk-of-harm product where injury has not yet been reported scores High (3).
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Core Biopsy Trays, Catalog Number 8673R4, distributed nationwide. A total of 285 units are affected, with lot numbers 2031043, 2130119, 2130382, 2130830, and 2130997.
The manufacturer identified that the test methods used to validate the manufacturing process may not have been adequately validated. This means the company cannot confirm that the devices were properly tested to meet specifications for safety and effectiveness.
Healthcare facilities and users in possession of these trays should discontinue use and contact Busse Hospital Disposables, Inc. for instructions on return or replacement. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Core Biopsy Tray Catalog Number: 8673R4
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- manufacturing-validation-failure
- inadequate-testing
- undiscovered-defect-risk
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: 2031043 2130119 2130382 2130830 2130997 UDI: 00849233017092
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