Early Alert

36 recalls on record · Last recall: Sep 23, 2026

Read the history in context

Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious

Class II — Moderate

Class III — Low Risk

Unclassified

Recall Timeline

FDASep 23, 2026

Early Alert: Heart Pump Controller Issue from Abiomed

Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records.

FDASep 23, 2026

Early Alert: Ventilator Issue from React Health

IFT cable connector on VOCSN devices may become unseated and lose communication with internal flow transducer board leading to reboots, System Fault 10 Alarms.

FDASep 3, 2026

Early Alert: Heart Pump Controller Purge Cassette Issue from Abiomed

Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.

FDASep 3, 2026

Early Alert: Breathing Circuit Issue from Draeger

Removal of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilation or delayed therapy.

FDASep 2, 2026

Early Alert: Convenience Kit Issue from AVID Medical

AVID Medical is correcting convenience kits containing recalled Huons Co. sodium chloride ampules.

FDAAug 28, 2026

Early Alert: Angiographic Catheter Issue from Boston Scientific

Boston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism

FDAAug 28, 2026

Early Alert: IV Start Kit Issue from Avid Medical

Avid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides.

FDAAug 27, 2026

Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging

The Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device.

FDAAug 24, 2026

Early Alert: Convenience Kit Issue from AVID Medical

Certain AVID Medical convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination

FDAAug 24, 2026

Early Alert: Convenience Kit Issue from Medline

Certain Medline convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination

FDAAug 24, 2026

Early Alert: Nitric Oxide Delivery System Issue from NOxBOX

The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy

FDAAug 24, 2026

Early Alert: Ventilator Issue from CooperSurgical

The cannula sets may exhibit a loose connection between the flexible tubing and the nasal cannula resulting in reduced effectiveness and decreased oxygenation.

FDAAug 21, 2026

Early Alert: Epidural Kit Issue from Medical Action Industries

Medical Action Industries is correcting epidural kits containing recalled Huons Co. sodium chloride ampules.

FDAAug 21, 2026

Early Alert: Breathing Circuit Issue from Medline

Medline is recalling certain neonatal and infant heated wire breathing circuits due to failures involving the electrical connector.

FDAAug 21, 2026

Early Alert: Portrait Core Services Software Issue from GE HealthCare

Patients monitored on Portrait Mobile devices can be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software.

FDAAug 18, 2026

Early Alert: Convenience Kit Issue from Becton Dickinson

BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules

FDAAug 4, 2026

Early Alert: Intraosseous Needle Set Issue from Becton Dickinson

BD is recalling certain BD Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator (stylet) following placement.

FDAJul 24, 2026

Early Alert: Percutaneous Catheter Issue from Boston Scientific

ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use

FDAJul 20, 2026

Early Alert: Intravascular Administration Set Issue from Baxter

Baxter administration sets may have air bubbles in the drip chamber and tubing, which may result in air being delivered through the IV line to the patient.

FDAJul 15, 2026

Early Alert: Ventilator Issue from Resmed

Failure of an electrical component in certain Astral ventilators may cause an interruption or failure in therapy which may result in serious injury or death

FDAJul 9, 2026

Early Alert: Convenience Kit Issue from Medical Action Industries

Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.

FDAJul 9, 2026

Early Alert: Convenience Kits Issue from Medline

Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.

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 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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