Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0565-2019·Announced 2018-12-19

CIVCO Biopsy Bracket Recalled for Missing Product Labeling

CIVCO Medical Instruments is recalling 73 boxes of Biopsy Brackets because some units lack required product labeling.

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: The recall is classified as FDA Class II due to missing product labeling, which is a documentation and labeling issue rather than a direct physical hazard or contamination risk.

Plain-English summary

CIVCO Medical Instruments Co., Inc. is voluntarily recalling 73 boxes of CIVCO Biopsy Bracket, REF P03122-07. These are reusable, non-sterile, single-angle brackets designed for use with SonoSite L25 series transducers. The recall was initiated on November 2, 2018, and was terminated on November 20, 2020.

The reason for the recall is that some brackets in inventory no longer have the product labeling. The affected units include boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, as well as any brackets in inventory that are missing their product labels.

The affected products were distributed to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom. The FDA classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
Manufacturer: CIVCO Medical Instruments Co., Inc.
Category: Medical Device — Biopsy Bracket
Hazard: mis-labeling
Affected units: 73

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 (4)

Boxes with lot numbers between A000012-A050663
M000880-M995980
and P022503
and all brackets in inventory that no longer have the product labeling.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 15 recalled by CIVCO Medical Instruments Co., 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 15 products in this recall →

Same manufacturer · CIVCO Medical Instruments Co., Inc.

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Same hazard · mis labeling