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Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom

Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom Recalls

All product recalls associated with Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom.

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Recall Summary

Total Recalls

1000

Past Year

579

Class I (Serious)

Most Recent

Dec 2025

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 3061–3080 of 10937 recalls

Gelsoft Plus Devices (Vascutek) – Incorrect IFU Distribution (2021)

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Low

FDAJul 8, 2021PR• Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom

Prelude SNAP Sheath (Merit) – Size Packaging Error (2021)

There is a potential that 7F sheaths are packaged as 10F sheaths.

High

FDAJun 30, 2021AL, AR, CA +26 more• Merit Medical Systems, Inc.

L43K Intraoperative Probe (Hitachi) – Screw Cover Failure (2021)

The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.

Moderate

FDAJun 30, 2021

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Page 154 of 547Next

Nationwide

• Hitachi Healthcare Americas Corporation

Zyprexa Intramuscular (Eli Lilly) – Appearance Abnormality (2021)

cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.

Class IIModerate

FDAJun 29, 2021IN, MS, OH• Eli Lilly & Company

Black Rifle Coffee Mac V (Black Rifle) – Possible Plastic Contamination (2021)

Possible plastic within final product packaging.

Class IIILow

FDAJun 29, 2021TN• Black Rifle Coffee Company

Cutting Electrode (Richard Wolf) – Mislabeled Product (2021)

Laceration Risk

Product labeled as Cutting Electrode may contain BIVAP electrode.

Low

FDAJun 25, 2021Nationwide• Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany

OPTI SARS-CoV-2 RT-PCR Test (OPTI Medical Systems) – False Positive Risk (2021)

The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.

High

FDAJun 25, 2021AL, CT, FL +7 more• OPTI Medical Systems, Inc

Dole Blueberries (Dole) – Cyclospora Risk (2021)

Canadian Food Inspection Agency tested blueberries and found Cyclospora cayetanensis.

Class IIModerate

FDAJun 25, 2021AR, IL, WI• Dole Fresh Fruit Company

Jersey Cookie Monster Ice Cream (Greenwood) – Undeclared Soy (2021)

Undeclared Soy

During an FDA inspection the firm was notified that their ingredient statement does not include soy. Undeclared soy in ice cream

Class IIModerate

FDAJun 24, 2021AL, GA, NC +2 more• Greenwood Ice Cream

MYLA Software (BioMerieux) – Result Alteration Risk (2021)

Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.

Moderate

FDAJun 22, 2021Nationwide• BioMerieux SA Chemin De L'Orme Marcy L'Etoile France

Limar Hand Sanitizer (Ardil) – Misleading Packaging (2021)

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

Class IHigh

FDAJun 22, 2021IN• Ardil Comercial S.R.L.

HysteroLux Fluid Management System (WOM World of Medicine) – Display Freeze Issue (2021)

When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.

Moderate

FDAJun 18, 2021Nationwide• WOM World of Medicine AG Salzufer 8 Berlin Germany

Ilizarov Wire Tensioner (Medicalplastic) – Manufacturing Error (2021)

Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensioner.

Moderate

FDAJun 17, 2021TN• Medicalplastic S.R.L. Via Saverio Mercadante

24-inch Dishwashers (Cove Appliance) – Fire Hazard (2021)

Fire/Burn Risk

This recall involves Cove Appliance 24-inch built-in residential dishwashers model numbers DW2450 and DW2450WS. The recalled dishwashers have serial numbers 20000100 through 20044445. The model number, serial number and date code are printed on the product rating plate located inside the dishwasher. "Cove" is printed on the outside of the door and on the far right side of the control panel, located on the top of the unit's door.

High

CPSCJun 16, 2021Nationwide• Cove Appliance Inc., of Madison, Wis.

Proteus 235 Proton System (Ion Beam Applications) – Popup Message Issue (2021)

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

Moderate

FDAJun 14, 2021Nationwide• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

Green Pace Chili (Pacific Meridian) – Plastic Contamination (2021)

Customer reporting finding plastic pieces in Green Pace Chili Diced 3/8" imported from Mexico.

Class IIModerate

FDAJun 14, 2021TX• Pacific Meridian Group, LLC

OEC 3D Imaging X-Ray System (GE OEC Medical) – Battery Depletion Risk (2021)

There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.

Moderate

FDAJun 10, 2021Nationwide• GE OEC Medical Systems, Inc

OEC Elite Mobile C-arm (GE OEC Medical) – Battery Depletion Issue (2021)

There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.

Moderate

FDAJun 10, 2021Nationwide• GE OEC Medical Systems, Inc

BasixALPHA Inflation Device (Merit Medical) – Handle Separation Risk (2021)

Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

Moderate

FDAJun 10, 2021Nationwide• Merit Medical Systems, Inc.

Advanced Perfusion System 1 (Terumo) - Blender Initialization Fault (2021)

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

Moderate

FDAJun 8, 2021IN• Terumo Cardiovascular Systems Corporation