Key regulatory updates this week focused on FDA recalls and early alerts, together with safety and recall notices published by the Italian Ministry of Health.

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FDA Early Alert: Draeger Atlan A350 / A350 XL anesthesia workstations

Area: United States
Source: FDA (CDRH)
Document type: Early Alert / Device Correction

FDA published an Early Alert concerning Draeger Atlan A350 and A350 XL anesthesia workstations. According to the communication, Draeger is expanding a previous correction to include additional devices due to a manufacturing error that may cause the piston ventilator to fail before use or mechanical ventilation to fail during use.

FDA states that use of affected devices may lead to serious adverse health consequences, including hypoxia, loss of lung recruitment, bradycardia, cardiac arrest and death. As of 6 May 2026, FDA reported no injuries and no deaths associated with this issue.

Draeger will replace the ventilator motor assembly on affected devices, with customers to be contacted by their local Draeger Service Representative..

Reference: Early Alert: Anesthesia Machine Issue from Draeger, Inc.

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FDA Class I Recall: AVID Medical convenience kits containing Namic RA syringes

Area: United States
Source: FDA (CDRH)
Document type: Recall / Early Alert Update

FDA updated its communication concerning AVID Medical convenience kits containing Namic RA syringes. The agency states that the recall has been identified as the most serious type and that continued use of the affected devices may cause serious injury or death.

The recall concerns convenience kits containing syringes affected by the Medline Namic Angiographic Control Syringes with Rotating Adaptor recall. According to FDA, the rotating adaptor on affected devices may unwind during use, potentially resulting in a loose connection or complete disconnection between the syringe and manifold.

FDA reports that this issue may result in biohazard exposure, blood loss, infection or air embolism. As of 13 March 2026, Medline Industries had reported four serious injuries and no deaths associated with the issue.

Reference: Convenience Kit Recall: AVID Medical Removes Convenience Kits Containing Namic RA Syringes

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Italy: Ministry of Health recall notice for NAMIC ANGIOGRAPHIC CONTROL SYRINGE

Area: Italy
Source: Ministero della Salute
Document type: Recall

The Italian Ministry of Health published a recall notice for NAMIC ANGIOGRAPHIC CONTROL SYRINGE, manufactured by Medline Industries Inc.

The notice reports a receipt date and last update date of 15 May 2026 and includes the related Field Safety Notice (FSN) documentation.

Reference: NAMIC ANGIOGRAPHIC CONTROL SYRINGE – Avviso di sicurezza / Recall (FSN)

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Italy: Ministry of Health safety information notice for SCHILLER FRED EASY G2 DA

Area: Italy
Source: Ministero della Salute
Document type: Safety Information Notice

The Italian Ministry of Health published a safety information notice for the FRED EASY G2 DA device, manufactured by Schiller Medical SAS.

The notice reports a receipt date of 12 May 2026 and a last update date of 13 May 2026, with the related Field Safety Notice (FSN) documentation attached.

Reference: FRED EASY G2 DA – Avviso di sicurezza (FSN)

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Italy: Ministry of Health recall notice for ADHESE 2 VIVAPEN kit and cannulas

Area: Italy
Source: Ministero della Salute
Document type: Recall

The Italian Ministry of Health published a recall notice for ADHESE 2 VIVAPEN KIT E CANNULE DC PER VIVAPEN, manufactured by Ivoclar Vivadent AG.

The notice reports a receipt date and last update date of 12 May 2026 and includes the related Field Safety Notice (FSN) documentation.

Reference: ADHESE 2 VIVAPEN KIT E CANNULE DC PER VIVAPEN – Avviso di sicurezza / Recall (FSN)