Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Beckman Coulter Inc.

Beckman Coulter Inc. Recalls

All product recalls associated with Beckman Coulter Inc..

Get alerts for this brand

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 4201–4220 of 11124 recalls

MicroScan WalkAway-40 Plus (Beckman Coulter) – Reagent Draw Straw Issue (2019)

Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

Moderate

FDASep 4, 2019CO, FL, IL +12 more• Beckman Coulter Inc.

Opiate 300 Ng Reagent (Beckman Coulter) – Cross-Reactivity Concern (2019)

Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.

Low

FDASep 4, 2019Nationwide• Beckman Coulter Inc.

MicroScan WalkAway-40 Plus Reconditioned (Beckman Coulter) – Reagent Draw Straw Issue (2019)

Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

1...209 210211212 213...557

Page 211 of 557Next

Moderate

FDASep 4, 2019CO, FL, IL +12 more• Beckman Coulter Inc.

MicroScan WalkAway-96 Plus (Beckman Coulter) – Reagent Draw Straw Issue (2019)

Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

Moderate

FDASep 4, 2019CO, FL, IL +12 more• Beckman Coulter Inc.

Solarice Balloon Dilatation Catheter (Medtronic) – Removal Difficulty (2019)

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

Moderate

FDASep 3, 2019Nationwide• Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland

Euphoria Balloon Dilatation Catheter (Medtronic) – Removal Difficulty (2019)

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

Moderate

FDASep 3, 2019Nationwide• Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland

SPROTTE Lumbar with Introducer (Pajunk) – Packaging Sterility Issue (2019)

Problem with packaging sealing process which affects sterility.

Moderate

FDAAug 30, 2019Nationwide• Pajunk GmbH Karl-hall-str. 1 Geisingen Germany

Milk of Magnesia (Plastikon) – Microbial Contamination (2019)

Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.

Class IHigh

FDAAug 30, 2019Nationwide• Plastikon Healthcare LLC

Lively Mobile Plus Alert Device (GreatCall) – Call Button Failure (2019)

This recall involves Lively Mobile Plus model GCR4 emergency alert devices manufactured between January and April 2019. The recalled devices are silver and black and have "GreatCall" printed near the top of the front of the device. The model number GCR4 is printed on the back and the date code 19.01 or 19.03 is printed on the bar code label of the device. The device is worn on a magnetic lanyard around a consumer's neck for fall detection or clips onto a consumer's purse, belt, or pocket, and is used to communicate in an emergency or for other assistance.

High

CPSCAug 30, 2019Nationwide• Borqs Hong Kong Limited

Dario Blood Glucose Monitoring System (LABSTYLE) – Reading Log Duplication (2019)

The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.

Moderate

FDAAug 29, 2019Nationwide• LABSTYLE INNOVATIONS 7, Derekh Menakhem Begin Ramat Gan Israel

Fexofenadine Tablets (AVKARE) – Stability Failure (2019)

Failed Stability Specifications.

Class IIModerate

FDAAug 28, 2019Nationwide• AVKARE Inc.

Ancient Youth Secret Bottles (Jivan Shakti) – Vitamin Mislabeling (2019)

Product label declares Vitamin D3 at 200 IU per serving. FDA sample analysis revealed no Vitamin D in product.

Class IIILow

FDAAug 28, 2019AZ, CA, CT +17 more• Jivan Shakti Inc.

Karl Storz Flexible Neuroscope (KARL STORZ) – Manual Error (2019)

During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.

High

FDAAug 27, 2019AL, AZ, CA +25 more• Karl Storz Endoscopy

Karl Storz Fiberscope (KARL STORZ) – Manual Error (2019)

High

FDAAug 27, 2019AL, AZ, CA +25 more• Karl Storz Endoscopy

Karl Storz Pediatric Neuroscope (KARL STORZ) – Manual Error (2019)

High

FDAAug 27, 2019AL, AZ, CA +25 more• Karl Storz Endoscopy

Lamivudine Tablets (American Health) – Labeling Error (2019)

Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.

Class IIILow

FDAAug 27, 2019Nationwide• American Health Packaging

Assorted Dried Fruits-Apple (Krasnyi Oktyabr) – Undeclared Sulfites (2019)

Undeclared Allergen

Product contains undeclared sulfites.

Class IHigh

FDAAug 23, 2019CA, CO, IL +6 more• Krasnyi Oktyabr Inc. USA

Monaco Radiation Treatment Planning System (ELEKTA) – Reporting Error (2019)

Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.

Moderate

FDAAug 23, 2019IN, OH• Elekta, Inc.

Tainy Vostoka Dried Fruits (Krasnyi Oktyabr) – Undeclared Sulfites (2019)

Undeclared Allergen

Product contains undeclared sulfites.

Class IHigh

FDAAug 23, 2019CA, CO, IL +6 more• Krasnyi Oktyabr Inc. USA

Wintergreen Essential Oil (Piping Rock) – Child Safety Issue (2019)

The recalled PipingRock wintergreen 100% pure essential oil is in a 1/2 fl. oz. (15 ml) glass amber dropper bottle. It has a black cap and a yellow, red and green label with PipingRock Wintergreen Oil Gaultheria procumbens 100% Pure Essential Oil printed on the front. Product number NT6446, UPC code 610256764467 and lot number 1905, 4000, 5980, 7420, 9344, 11202, 27180, 31397, 37913, 43369, 45843 or 56439 are printed on the back of the product.

High

CPSCAug 22, 2019Nationwide• Piping Rock Health Products, of Ronkonkoma, N.Y.