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November 03, 2023
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Harvard Drug Group, Cardinal Health voluntarily recall eye drop products

Harvard Drug Group, Cardinal Health voluntarily recall eye drop products

The Harvard Drug Group and Cardinal Health have initiated voluntary recalls on certain over-the-counter ophthalmic products after the FDA warned about unsanitary conditions in the manufacturing facility.

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September 26, 2023
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ALK-Abelló withdraws lot of pecan nut allergen extract

ALK-Abelló withdraws lot of pecan nut allergen extract

ALK-Abelló has voluntarily withdrawn lot No. 0003963971 of its pecan nut allergen extract due to false-negative skin test results, including a case of life-threatening anaphylaxis, according to an FDA MedWatch alert.

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August 23, 2023
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FDA warns certain MSM eye drops have bacterial, fungal contamination

FDA warns certain MSM eye drops have bacterial, fungal contamination

The FDA has issued a warning to consumers not to purchase and to immediately stop use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops because of bacterial and fungal contamination.

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August 18, 2023
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Abiomed recalls instructions for use for right heart pump due to risk for blood clots

Abiomed recalls instructions for use for right heart pump due to risk for blood clots

Abiomed announced a recall of the labeling for its right heart pump system catheter because its instructions for use do not appropriately address precautions for patients with anticoagulation clotting time below recommended value.

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August 10, 2023
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FDA designates recall of two intra-aortic balloon pumps as class I

FDA designates recall of two intra-aortic balloon pumps as class I

The FDA announces a recall of intra-aortic balloon pumps manufactured by Datascope/Maquet/Getinge due to risk for unexpected shutdown due to electrical failure in the power management or solenoid boards.

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July 28, 2023
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FDA identifies GE HealthCare recall of sensors for defibrillators as class I

FDA identifies GE HealthCare recall of sensors for defibrillators as class I

GE HealthCare announced a recall of arterial oxygen saturation sensors due to a malfunction that may reduce the amount of energy sent to the heart during defibrillation without notification to the care provider.

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July 27, 2023
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Abiomed recalls LVADs for motor damage risk after contact with TAVR stent

Abiomed recalls LVADs for motor damage risk after contact with TAVR stent

Abiomed announced a recall of its left ventricular assist device due to instructions for use that do not adequately address device use in patients who have undergone transcatheter aortic valve replacement.

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July 26, 2023
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Abbott recall of LAAO catheters designated class I

Abbott recall of LAAO catheters designated class I

Abbott announced a recall of its cardiac catheter used in procedures for left atrial appendage occlusion due to risk for air embolism, potentially causing stroke or death.

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July 14, 2023
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FDA issues two class I recalls involving ventilators

FDA issues two class I recalls involving ventilators

The FDA has issued class I recalls, the most serious kind, for two different ventilators.

News
July 07, 2023
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Cipla recalls six batches of albuterol inhalers for container defect

Cipla recalls six batches of albuterol inhalers for container defect

Six batches of albuterol sulfate inhalation aerosol 90 mcg (200 metered inhalation) were voluntarily recalled by the manufacturer due to container defects that may prevent them from releasing the proper dose.

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