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Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark Recalls

All product recalls associated with Radiometer Medical ApS Akandevej 21 Bronshoj Denmark.

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Recall Summary

Total Recalls

1000

Past Year

731

Class I (Serious)

175

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 1121–1140 of 11123 recalls

ABL800 FLEX Analyzer (Radiometer) – Calibration Solution Issue (2024)

Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.

Moderate

FDAMay 31, 2024Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Phenazopyridine HCl Tablets (RemedyRepack) – Product Mix Up (2024)

Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Class IIModerate

FDAMay 31, 2024Nationwide• RemedyRepack Inc.

Potassium Chloride Capsules (Glenmark) – CGMP Deviations (2024)

CGMP Deviations

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Class II

Moderate

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

Class IHigh

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

Class IHigh

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – CGMP Deviations (2024)

CGMP Deviations

Class IIModerate

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Colby Jack Cheese Slices (Tillamook) – plastic material (2024)

Plastic material. The piece of plastic material was detected in a 40lb. cheese block and smaller fragments of the plastic material may be found in the cheese slices.

Class IIModerate

FDAMay 30, 2024IN, UT, WA• Tillamook County Creamery Association

Beckman Coulter IGM Reagent (Beckman Coulter) – Lipemia Result Inaccuracy (2024)

LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal

Moderate

FDAMay 27, 2024Nationwide• Beckman Coulter Inc.

CentriMag Primary Console (Thoratec) – Power Standard Nonconformance (2024)

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

High

FDAMay 22, 2024Nationwide• Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland

Endo Model M Tibial Components (Waldemar Link) – Surgical Screw Issue (2024)

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

High

FDAMay 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

DxI 9000 Access Analyzer (Beckman Coulter) – Laboratory System Compatibility (2024)

When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

Moderate

FDAMay 22, 2024Nationwide• Beckman Coulter, Inc.

Endo Model SL Tibial Components (Waldemar Link) – Surgical Screw Problem (2024)

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

High

FDAMay 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

KIDRON REFRIGERATED TRAILER (KIDRON) – Wheel Lug Nut Issue (2024)

ST Engineering Hackney, Inc. (STE Hackney) is recalling certain 2023-2024 Kidron Refrigerated Trailers. The wheel lug nuts may not be tightened properly.

High

NHTSAMay 22, 2024Nationwide• KIDRON

Beckman Coulter DxI 9000 Analyzer (Beckman Coulter) – System Connectivity (2024)

The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.

Moderate

FDAMay 22, 2024Nationwide• Beckman Coulter, Inc.

Tivicay PD (GlaxoSmithKline) – Incorrect Expiration Label (2024)

Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.

Class IIILow

FDAMay 17, 2024Nationwide• GlaxoSmithKline LLC

Duloxetine Capsules (Breckenridge) – Impurity Concern (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAMay 17, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Super Lube Products (Kano Laboratories) – Poisoning Risk (2024)

Fire/Burn Risk

The recall involves Super Lube products which include the following: Syncopen Synthetic Penetrant, Fire Resistant Hydraulic Fluid, and Metal Protectant and Corrosion Inhibitor. The products are used to prevent corrosion in various machinery. Super Lube Syncopen Synthetic Penetrant was sold in a four-ounce white spray bottle (item number 85004), a 32-ounce or one-quart trigger spray black plastic bottle (item number 85032), and a one-gallon (item number 85010) white plastic bottle with a handle. The container bears the brand Super Lube followed by a flag of green, blue, orange, and yellow stripes. Super Lube Fire Resistant Hydraulic Fluid was sold in a one-gallon white plastic bottle (item number 86010) with a handle. Super Lube Metal Protectant & Corrosion Inhibitor was sold in a 32-ounce or one-quart trigger spray black plastic bottle with a handle (item numbers 83032 / 83032A). The Super Lube products have one of the following lot numbers located on the bottom or rear label: Super Lube Syncopen Synthetic Penetrant Size Item Number Lot Number 1.0 Gallon Bottle 85010 17348 L24 - 23320 K26 1.0 Quart Trigger Sprayer 85032 17290 J35 - 23320 K26 4 ounce Bottle 85004 17348 L24 - 23320 K26 Super Lube Fire Resistant Hydraulic Fluid Size Item Number Lot Number 1 Gallon Bottle 86010 16120 D48 - 24040 B16 Super Lube Metal Protectant & Corrosion Inhibitor Size Item Number 1 Quart Trigger Sprayer 83032 / 83032A 17348 L24 - 23297 J49

High

CPSCMay 16, 2024Nationwide• Kano Laboratories LLC, of Bohemia, New York

Ultrathane Cook-Cope Drainage Catheter (Cook) – Incorrect Expiration (2024)

Product labels state the incorrect expiration dates that extends beyond their true expiration date

Low

FDAMay 15, 2024MA• Cook Incorporated

Volkswagen ID.4 (Volkswagen) – Software Issue (2024)

Volkswagen Group of America, Inc. (VW) is recalling certain 2021-2023 ID.4 vehicles. Due to a software issue, affected vehicles may experience center displays and instrument panel displays that do not boot, or that sporadically reset. This can result in loss of speedometer information or loss of rearview camera image. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard numbers 101, "Control and Displays" and 111, "Rear Visibility."

High

NHTSAMay 15, 2024Nationwide• VOLKSWAGEN

Viking Towable VWT26SBHSAGA (Viking) – Plumbing Defect (2024)

Forest River, Inc. (Forest River) is recalling certain 2020-2023 Coachmen Independence Trail, 2020-2024 Viking, and 2021-2024 Clipper travel trailers. The freshwater tank may detach from the vehicle when full or overfilled.

Low

NHTSAMay 15, 2024Nationwide• VIKING TOWABLE