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BRS Analytical Services, LLC

BRS Analytical Services, LLC Recalls

All product recalls associated with BRS Analytical Services, LLC.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

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 921–940 of 21319 recalls

Polyvinyl Alcohol Eye Drops (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class IIModerate

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Lubricant Eye Drops (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class IIModerate

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Carboxymethylcellulose Eye Gel (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class II

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Moderate

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Artificial Tears Solution (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class IIModerate

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Carboxymethylcellulose Eye Solution (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class IIModerate

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Endopath Echelon Vascular Reload (Ethicon) – Instrument Lockout (2025)

Laceration Risk

Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.

Very High

FDAApr 22, 2025Nationwide• Ethicon Endo-Surgery Inc

Plum Solos Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

High

FDAApr 22, 2025Nationwide• ICU Medical, Inc.

IC BUS CESB (IC BUS) – Seat Belt Fastener Risk (2025)

International Motors, LLC (International) is recalling certain 2025-2026 IC CESB and 2025 EVSB school buses. The driver's seat belt anchor bolt may come loose.

High

NHTSAApr 22, 2025Nationwide• IC BUS

Plum Duo Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

High

FDAApr 22, 2025Nationwide• ICU Medical, Inc.

Lower Extremity Implant (American Contract) – EO/ECH Residuals (2025)

Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.

Moderate

FDAApr 21, 2025Nationwide• American Contract Systems, Inc.

BD Cathena IV Catheter (BD) – Septum Defect Risk (2025)

Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.

Moderate

FDAApr 21, 2025Nationwide• Becton Dickinson Infusion Therapy Systems, Inc.

EVENITY Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

BENLYSTA Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

PROLIA Injection (Mckesson) - Temperature Excursion (2025)

CGMP Deviations; potential temperature excursions due to transit delays

Class IIModerate

FDAApr 21, 2025FL, OH, VA• Mckesson Medical-Surgical Inc. Corporate Office

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIModerate

FDAApr 18, 2025Nationwide• American Regent, Inc.

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIModerate

FDAApr 18, 2025Nationwide• American Regent, Inc.

Clindamycin Hydrochloride Capsules (Preferred Pharmaceuticals) - CGMP Issues (2025)

cGMP Deviations

Class IIModerate

FDAApr 18, 2025Nationwide• Preferred Pharmaceuticals, Inc.

Ropivacaine Hydrochloride Injection (Amneal) – Particulate Matter (2025)

Presence of Particulate Matter

Class IHigh

FDAApr 17, 2025Nationwide• Amneal Pharmaceuticals, LLC

ADVIA Centaur Calibrator (Siemens) – Reference Interval (2025)

Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

Moderate

FDAApr 15, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica Homocysteine Calibrator (Siemens) – Reference Interval (2025)

Moderate

FDAApr 15, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.