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Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany Recalls

All product recalls associated with Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany.

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Recall Summary

Total Recalls

1000

Past Year

899

Class I (Serious)

125

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 401–420 of 17592 recalls

Plastic Trial Head (Waldemar Link) – Labeling Inconsistency (2025)

Inconsistent size terminology and color coding used on labeling

Moderate

FDAJul 15, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Duloxetine Capsules (Breckenridge Pharmaceutical) – Impurity Concern (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

Class IIModerate

FDAJul 15, 2025Nationwide• Breckenridge Pharmaceutical, 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

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Moderate

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

American Contract Systems Kits (ACS) – Sterilization Concern (2025)

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Moderate

FDAJul 14, 2025IL, LA• American Contract Systems Inc

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

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

Plum Duo Infusion System (ICU Medical) – Interface Problem (2025)

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.

Moderate

FDAJul 11, 2025Nationwide• ICU Medical, Inc.

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

Access Thyroglobulin Assay (Beckman Coulter) – Result Inaccuracy (2025)

Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.

Moderate

FDAJul 10, 2025Nationwide• Beckman Coulter, Inc.

Vercise Brain Stimulation System (Boston Scientific) – Wire Break Risk (2025)

Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

High

FDAJul 8, 2025Nationwide• Boston Scientific Neuromodulation Corporation

Burr Hole Cover Kit (Boston Scientific) – Clip Locking Problem (2025)

Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.

Low

FDAJul 8, 2025Nationwide• Boston Scientific Neuromodulation Corporation

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

Reading Rail Gear Trucks HD (Reading) – Weld Crack Risk (2025)

Reading Truck Body, LLC (Reading) is recalling certain 2021 Rail Gear HD trucks. Welds may crack and fail, allowing the front rail gear to shift and contact the road.

High

NHTSAJul 7, 2025Nationwide• READING TRUCK EQUIPMENT

Timolol Maleate Ophthalmic Solution (FDC) – Defective Container (2025)

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

Class IIModerate

FDAJul 5, 2025Nationwide• FDC Limited

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Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany Recalls

Recall Summary

Plastic Trial Head (Waldemar Link) – Labeling Inconsistency (2025)

Duloxetine Capsules (Breckenridge Pharmaceutical) – Impurity Concern (2025)

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

American Contract Systems Kits (ACS) – Sterilization Concern (2025)

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

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

Plum Duo Infusion System (ICU Medical) – Interface Problem (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)

Access Thyroglobulin Assay (Beckman Coulter) – Result Inaccuracy (2025)

Vercise Brain Stimulation System (Boston Scientific) – Wire Break Risk (2025)

Burr Hole Cover Kit (Boston Scientific) – Clip Locking Problem (2025)

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

Reading Rail Gear Trucks HD (Reading) – Weld Crack Risk (2025)

Timolol Maleate Ophthalmic Solution (FDC) – Defective Container (2025)