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RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom

RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom Recalls

All product recalls associated with RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom.

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Recall Summary

Total Recalls

1000

Past Year

726

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 3601–3620 of 11124 recalls

Amylase AY3805 (RANDOX) - Performance Claim Failure (2020)

Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.

Low

FDAJul 10, 2020MA, NM, WV• RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom

Auryxia Tablets (Keryx Biopharmaceuticals) – Manufacturing Deviation (2020)

cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.

Class IIModerate

FDAJul 10, 2020Nationwide• Keryx Biopharmaceuticals, Inc.

Mako Hip End Effector (Mako Surgical) - Bone Preparation Issue (2020)

Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

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Moderate

FDAJul 9, 2020AZ, CA, FL +5 more• Mako Surgical Corporation

Keystone Raptor (KEYSTONE) - Electrical Equipment Fault (2020)

Keystone RV Company (Keystone) is recalling certain 2019-2020 Keystone Carbon, Cougar, Fuzion, Impact and Raptor fifth-wheel trailers equipped with a Furrion over the air (OTA) wing-style television antenna. The antenna may separate from the mounting base during transit, becoming a road hazard.

Moderate

NHTSAJul 7, 2020Nationwide• KEYSTONE

Oats & Honey Granola (KIND LLC) – undeclared sesame (2020)

Undeclared Allergen

Product contains undeclared sesame seeds.

Class IIModerate

FDAJul 7, 2020AL, AZ, AR +39 more• KIND LLC

Carbamazepine Tablets (RemedyRepack) – Dissolution Specification Failure (2020)

FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.

Class IIModerate

FDAJun 29, 2020MN• RemedyRepack Inc.

Randox Lipase Assay (Randox) – Quality Control Imprecision (2020)

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.

Moderate

FDAJun 26, 2020Nationwide• RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom

Red Velvet Layered Cheesecake (Chuckanut Bay) – Undeclared Walnut (2020)

Undeclared Allergen

Undeclared walnut. Carrot Cake Layered Cheesecake was incorrectly decorated as Red Velvet Layered Cheesecake and was mis-labeled. Finished product label does not declare walnut.

Class IIModerate

FDAJun 25, 2020CA, IN• Chuckanut Bay Foods LLC

PrepIT Q2A Kit (DNA Genotek) – Expired Reagent Risk (2020)

Reagents were shipped to customers after the Use by data indicated on its labeling.

Moderate

FDAJun 24, 2020Nationwide• DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada

Volkswagen Golf (Volkswagen) – VIN Label Mismatch (2020)

Fire/Burn Risk

Volkswagen Group of America, Inc. (Volkswagen) is recalling two 2018 Golf GTI vehicles. The VIN printed on the Federal Certification label may not match the actual VIN on the vehicle. As such, these vehicles fail to comply with the requirements of 49 CFR Part 567, "Certification."

High

NHTSAJun 24, 2020Nationwide• VOLKSWAGEN

Neurosign V4 Monitor (Magstim) – Cable Connection Risk (2020)

Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the internal construction of the cables.

Moderate

FDAJun 23, 2020MN• The Magstim Company Limited Spring Gardens Whitland United Kingdom

Sutter Swyng Forceps (Sutter) – Labeling Inconsistency (2020)

The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol for sterilization using Ethylene Oxide with the description for sterilization using irradiation.

Low

FDAJun 23, 2020Nationwide• Sutter Medizintechnik GmbH Tullastr. 87 Freiburg Im Breisgau Germany

SafeStep Huber Needle Set (BD) – Tubing Crack Risk (2020)

Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

High

FDAJun 19, 2020Nationwide• Becton Dickinson & Company