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Nephron Sterile Compounding Center LLC

Nephron Sterile Compounding Center LLC Recalls

All product recalls associated with Nephron Sterile Compounding Center LLC.

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Recall Summary

Total Recalls

1000

Past Year

581

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 2141–2160 of 10937 recalls

Labetalol HCl Injection (Nephron) – Manufacturing Contamination (2022)

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Class IIModerate

FDAAug 10, 2022Nationwide• Nephron Sterile Compounding Center LLC

CorVocet Biopsy System (Merit) – Needle Ejection (2022)

Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.

FDAAug 3, 2022AL, AK, AZ +40 more• Merit Medical Systems, Inc.

Smallbore Bifuse Extension Set (ICU Medical) – Manufacturing Gap (2022)

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

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FDA

Aug 1, 2022

AL, AK, AZ +49 more

• ICU Medical, Inc.

Extension Set with Clave (ICU Medical) – Manufacturing Gap (2022)

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

FDAAug 1, 2022AL, AK, AZ +49 more• ICU Medical, Inc.

Bifuse Pressure Infusion Set (ICU Medical) – Manufacturing Gap (2022)

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

FDAAug 1, 2022AL, AK, AZ +49 more• ICU Medical, Inc.

Smallbore Trifuse Extension Set (ICU Medical) – Manufacturing Gap (2022)

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

FDAAug 1, 2022AL, AK, AZ +49 more• ICU Medical, Inc.

Randox Serology Control (Randox) – Analyte Issue (2022)

***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient results due to the positive control O36SR testing negative (Non-Reactive) for Marker HBsAg

FDAAug 1, 2022Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland