The Recall Desk
ModerateFDA (Devices)·Z-1165-2022·Announced 2022-06-08

Stereo Breast Biopsy Tray Recalled for Manufacturing Test Validation Uncertainty

Busse Hospital Disposables recalls stereo breast biopsy trays due to uncertainty about the adequacy of manufacturing test validation. The recall affects 23 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 recall without reported illnesses or injuries. The hazard is manufacturing test validation uncertainty rather than a known contamination or device defect.

Plain-English summary

Busse Hospital Disposables, Inc. is recalling stereo breast biopsy trays (catalog number 2383R1). The recall involves 23 units distributed nationwide, with lot number 2130565 affected.

The recall was issued due to uncertainty regarding the adequacy of validation of the test methods used to manufacture the product. The FDA classified this as a Class II medical device recall.

Healthcare providers and consumers who have received or used affected units should contact Busse Hospital Disposables, Inc. for further information and instructions.

The recalled product

Product
Stereo Breast Biopsy Tray Catalog Number: 2383R1
Manufacturer
Busse Hospital Disposables, Inc.
Category
Medical Device — Biopsy Equipment
Hazard
  • validation-uncertainty

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: 2130565 UDI: 00849233004344

Distribution

Distributed nationwide across the United States.

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