Draeger Pulls Certain ErgoStar Catheter Mounts After Reports of Hose Cracking
The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.
Category: Recalls
Recalls
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Recalls
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Siemens Healthineers Corrects 3 Tesla MRI Systems Over Magnet Venting Blockage Risk
The issue affects certain systems in which ice may obstruct the venting system, potentially leading to dangerous overpressure events if a magnet quench occurs.
Recalls
Latest
Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
Recalls
Latest
Draeger Pulls Certain ErgoStar Catheter Mounts After Reports of Hose Cracking
The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.
FDA Issues Early Alert on Infusion Pump Issue from Baxter
The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.
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BD Recalls Alaris Pump Modules Serviced With Previously Recalled Parts
The voluntary recall involves pump modules that may have been repaired with FR-110 bezels, which the company says can weaken over time and compromise safe infusion delivery.
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SunMed Holdings Removes Adult Manual Resuscitator Devices
The Class I recall involves devices with incorrectly assembled B/V filters.
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BD Recalls Certain Alaris Pump Infusion Sets Over Accuracy Issues
Use with select infusion sets may lead to over- or under-infusion, bolus inaccuracies, and alarm delays, BD warns in recall notice.
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Disconnection Hazard Prompts Recall of AirLife Infant Ventilation Circuits
AirLife and manufacturer Vyaire are recalling certain infant heated wire circuits due to the risk that accessory adapters provided with the product may unintentionally disconnect during setup or use when the circuit reaches operating temperature.
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Medtronic Recalls Certain Newport Ventilators and Related Service Parts
Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation.
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Recalls
Latest
Zyno Medical Recalls Infusion Pumps Over Software Issue
Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.
