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MEDLINE INDUSTRIES, LP Northfield

MEDLINE INDUSTRIES, LP Northfield Recalls

All product recalls associated with MEDLINE INDUSTRIES, LP Northfield.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

143

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 3781–3800 of 37665 recalls

Medline Luer Slip Disposable Syringe (Medline) – volume accuracy issue (2024)

It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.

High

FDAApr 22, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Prucka 3 Amplifier (GE Medical) – capacitor failure (2024)

Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.

Moderate

FDAApr 22, 2024Nationwide• GE Medical Systems Information Technologies Inc

Ingenia 3.0T MRI System (Philips) – ventilation warning issue (2024)

Fire/Burn Risk

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation

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High

FDAApr 22, 2024Nationwide• Philips North America Llc

Xelpros (Sun Pharmaceutical) – Failed Particulate Test (2024)

Failed Release Testing: Out of specification for particulate matter test.

Class IIILow

FDAApr 22, 2024PA, TX• SUN PHARMACEUTICAL INDUSTRIES INC

Schwinnng Herbal Capsules (Stop Clopez) – Unapproved Marketing (2024)

Marketed Without An Approved NDA/ANDA

Class IHigh

FDAApr 22, 2024Nationwide• Stop Clopez Corp

Ingenia 1.5T MRI System (Philips) – ventilation warning issue (2024)

Fire/Burn Risk

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation

High

FDAApr 22, 2024Nationwide• Philips North America Llc

Patient Information Center iX (Philips) – data transfer problem (2024)

Event Catalog information does not save when copied and transferred from one unit to another.

Low

FDAApr 19, 2024Nationwide• Philips North America Llc

Tesla Model 3 (Tesla) – air bag module defect (2024)

Tesla, Inc. (Tesla) is recalling one 2024 Model 3 vehicle. The driver seat side air bag module was assembled without a deflector that directs gas flow during deployment.

High

NHTSAApr 19, 2024Nationwide• TESLA

Amphotericin B Liposome (Sun Pharmaceutical) – Assay Issue (2024)

Out of specification for assay

Class IIModerate

FDAApr 19, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Primal Kitchen Avocado Oil (Kraft Heinz) – Bottle Breakage (2024)

The product's glass bottle may be prone to breakage

Class IIModerate

FDAApr 19, 2024AZ, CA, GA +7 more• KRAFT HEINZ FOODS COMPANY

Optum Nimbus II Plus (OptumHealth) – infusion pump failure (2024)

Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.

High

FDAApr 18, 2024Nationwide• OptumHealth Care Solutions LLC

OPTETRAK One Peg Patella (Exactech) – packaging problem (2024)

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

High

FDAApr 18, 2024Nationwide• Exactech, Inc.

Synchro SELECT Guidewires (Stryker) – PTFE coating damage (2024)

Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

High

FDAApr 18, 2024Nationwide• Stryker Neurovascular

Synchro2 Guidewires (Stryker) – PTFE coating damage (2024)

High

FDAApr 18, 2024Nationwide• Stryker Neurovascular

DxI 9000 Access Immunoassay Analyzer (Beckman Coulter) – diagnostic device issue (2024)

Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator material with 2D calibrator card barcodes. This may cause a failed calibration curve. The health risk to patients is dependent upon the analytes that could be impacted by the error, to include receiving delayed or erroneous results. The issue was identified by Beckman Coulter while conducting a field action on DxI 9000 Access Immunoassay Analyzers.

High

FDAApr 18, 2024Nationwide• Beckman Coulter, Inc.

Vercise Genus DBS Implantable Pulse Generator (Boston Scientific) – system check issue (2024)

Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

High

FDAApr 18, 2024Nationwide• Boston Scientific Neuromodulation Corporation

OPTETRAK Three Peg Patella (Exactech) – packaging problem (2024)

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

High

FDAApr 18, 2024Nationwide• Exactech, Inc.

Mi1250 SYNCHRONY 2 (MED-EL) – internal electronics crack (2024)

A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

Moderate

FDAApr 18, 2024NC• MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria

OPTETRAK Advanced Patella (Exactech) – packaging problem (2024)

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

High

FDAApr 18, 2024Nationwide• Exactech, Inc.

Beckman Coulter DxL 9000 Analyzer (Beckman Coulter) – calibration request problem (2024)

When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.

High

FDAApr 18, 2024FL, GA, IN +6 more• Beckman Coulter, Inc.