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Early Alert

15 recalls on record · Last recall: Jun 18, 2026

Safety Score

57/100

Poor

Based on recall frequency and severity over the past 3 years, with older recalls weighted less.

Severity Breakdown

Class I — Serious
0
Class II — Moderate
0
Class III — Low Risk
0
Unclassified
15

Categories

MEDICATION

Recall Timeline

FDAJun 18, 2026

Early Alert: Catheter Introducer Issue from Abiomed and Oscor

Abiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.

FDAJun 16, 2026

Early Alert: Convenience Kit Issue from Windstone Medical Packaging, Inc.

Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile

FDAJun 11, 2026

Early Alert: Positive Pressure Breathing Device Issue from Baxter

Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.

FDAJun 8, 2026

Early Alert: Breathing Circuit Set Issue from Hamilton Medical

The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation

FDAJun 5, 2026

Early Alert: Infant Resuscitation System Issue from GE HealthCare

The air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, affecting the delivered oxygen concentration

FDAJun 4, 2026

Early Alert: Insulin Pump Issue from Insulet

Certain Omnipod Pods may have a tear in the tubing that allows insulin to leak outside the Pod instead of being delivered to the body.

FDAJun 2, 2026

Early Alert: Catheter Introducer Kit Issue from Abiomed

Prolonged use of the Abiomed 14Fr Low Profile Introducer may lead to thrombus formation

FDAMay 27, 2026

Early Alert: Heart Pump Issue from Abiomed

Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case

FDAMay 27, 2026

Early Alert: Heart Pump Issue from Abiomed

Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case

FDAMay 27, 2026

Early Alert: IV Tubing Set Issue from ICU Medical

Black specks and particulate matter have been reported in the drip chamber of certain ICU Medical IV tubing sets

FDAMay 21, 2026

Early Alert: Heart Pump Controller Issue from Abiomed

A software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.

FDAMay 15, 2026

Early Alert: Anesthesia Machine Issue from Draeger, Inc.

Draeger is correcting additional anesthesia workstations due to a manufacturing error that may cause the ventilator to fail before or during use.

FDAApr 28, 2026

Early Alert: Thoracic Stent Graft Issue from Bolton Medical

Affected grafts may not unclasp from the delivery system, which may require conversion to open surgical repair and can result in patient death

FDAApr 24, 2026

Early Alert: Automated Compounding System Issue from Omnicell

Certain labels used with i.V.Station automated compounding systems may not be detected, leading to mislabeled sterile filled syringes

FDAApr 24, 2026

Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers

Arrow International is removing dialysis catheter kits containing recalled Merit Medical Splittable Sheath Introducers

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