CIVCO Needle Guide Bracket Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 49 boxes of Needle Guide Brackets because some units lack required product labeling.
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: The recall is classified as FDA Class II and involves a labeling defect (missing product labeling) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is voluntarily recalling 49 boxes of CIVCO Needle Guide Brackets, REF 674-057. The recall was initiated on November 2, 2018, and was terminated on November 20, 2020. The FDA classified this recall as Class II.
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 all brackets in inventory that no longer have the product labeling. These reusable, non-sterile brackets are used with SonoSite L25 series transducers.
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 source text does not specify any reported illnesses or injuries associated with this recall.
The recalled product
- Product
- CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Hazard
- Affected units
- 49
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 →Related recalls
Same manufacturer · CIVCO Medical Instruments Co., Inc.
See all →- HighCivco eTRAX needle sensor may misreport needle tip position onscreen
FDA (Devices) · 2026-04-08
- HighCivco eTRAX 18G starter kit may misreport needle tip position
FDA (Devices) · 2026-04-08
- HighCivco eTRAX 14G needle sensor may misreport needle tip position
FDA (Devices) · 2026-04-08
- HighCivco eTRAX needle starter kit may misreport needle tip position
FDA (Devices) · 2026-04-08
- HighCivco eTRAX 18G needle sensor may misreport needle tip position
FDA (Devices) · 2026-04-08
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02