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Ascend Laboratories, LLC

Ascend Laboratories, LLC Recalls

All product recalls associated with Ascend Laboratories, LLC.

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Recall Summary

Total Recalls

1000

Past Year

442

Class I (Serious)

138

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 201–220 of 7663 recalls

Amlodipine Olmesartan Tablets (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications: low dissolution results

Class IIModerate

FDAJul 21, 2025Nationwide• Ascend Laboratories, LLC

SureStep Foley Tray System (Bard) – Labeling Inaccuracy (2025)

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

Moderate

FDAJul 17, 2025Nationwide• C.R. Bard Inc

SureStep Foley Tray System (Bard) – Labeling Inaccuracy (2025)

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Moderate

FDAJul 17, 2025Nationwide• C.R. Bard Inc

Sesame Seed Cookies (Cesarina) – Undeclared Sesame (2025)

Allergen not listed in the Contains statement: Sesame

Class IIILow

FDAJul 17, 2025FL, GA, IN +1 more• Cesarina Bakery, Inc

Mediterranean Mix Cookies (Cesarina) – Undeclared Sesame (2025)

Allergen not listed in the Contains statement: Sesame

Class IIModerate

FDAJul 17, 2025FL, GA, IN +1 more• Cesarina Bakery, Inc

3mensio Workstation (PIE Medical) – Measurement Error (2025)

When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage

Moderate

FDAJul 14, 2025Nationwide• PIE Medical Imaging B.V. Demertdwarsstraat 8A01 Maastricht Netherlands

BritePro Solo Mini (Flexicare) – Illumination Failure (2025)

Laryngoscope handles may not illuminate as intended.

Moderate

FDAJul 11, 2025Nationwide• Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China

Mercedes-Benz Metris (Mercedes-Benz) – Infotainment Failure (2025)

Daimler Vans USA, LLC (DVUSA) is recalling certain 2020-2023 Mercedes-Benz Metris vehicles. The electrical connections for the infotainment system may not be properly secured, which can cause the rearview camera image not to display. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 111, "Rear Visibility."

High

NHTSAJul 11, 2025Nationwide• MERCEDES-BENZ

BritePro Solo Handle (Flexicare) – Illumination Failure (2025)

Laryngoscope handles may not illuminate as intended.

Moderate

FDAJul 11, 2025Nationwide• Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China

Britepro Solo Stubby Handle (Flexicare) – Illumination Failure (2025)

Laryngoscope handles may not illuminate as intended.

Moderate

FDAJul 11, 2025Nationwide• Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China

IDM-ARLITE-R (mo-Vis) – Software Timing Error (2025)

Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.

High

FDAJul 10, 2025Nationwide• mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium

Rizatriptan Tablets (Ascend Laboratories) – Impurity Detection (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Rizatriptan Benzoate Tablets (Ascend) – CGMP Impurity (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

BD Trucount Controls (BD Bio Sciences) – Incorrect SD Values (2025)

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

Low

FDAJul 8, 2025Nationwide• Becton, Dickinson and Company, BD Bio Sciences

HeartSine SAM Defibrillators (HeartSine) – Component Malfunction (2025)

Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)

Moderate

FDAJun 30, 2025Nationwide• HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom

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Ascend Laboratories, LLC Recalls

Recall Summary

Amlodipine Olmesartan Tablets (Ascend) – Dissolution Failure (2025)

SureStep Foley Tray System (Bard) – Labeling Inaccuracy (2025)

SureStep Foley Tray System (Bard) – Labeling Inaccuracy (2025)

Sesame Seed Cookies (Cesarina) – Undeclared Sesame (2025)

Mediterranean Mix Cookies (Cesarina) – Undeclared Sesame (2025)

3mensio Workstation (PIE Medical) – Measurement Error (2025)

BritePro Solo Mini (Flexicare) – Illumination Failure (2025)

Mercedes-Benz Metris (Mercedes-Benz) – Infotainment Failure (2025)

BritePro Solo Handle (Flexicare) – Illumination Failure (2025)

Britepro Solo Stubby Handle (Flexicare) – Illumination Failure (2025)

IDM-ARLITE-R (mo-Vis) – Software Timing Error (2025)

Micro Joystick R-net (mo-Vis) – Software Timing Error (2025)

R-net Light Joystick (mo-Vis) – Software Timing Error (2025)

Multi Joystick R-net (mo-Vis) – Software Timing Error (2025)

IDM-MULTI-R (mo-Vis) – Software Timing Error (2025)

IDM-MICRO-R (mo-Vis) – Software Timing Error (2025)

Rizatriptan Tablets (Ascend Laboratories) – Impurity Detection (2025)

Rizatriptan Benzoate Tablets (Ascend) – CGMP Impurity (2025)

BD Trucount Controls (BD Bio Sciences) – Incorrect SD Values (2025)

HeartSine SAM Defibrillators (HeartSine) – Component Malfunction (2025)