fda regulated Recalls

1,319 recalls tagged with “fda regulated”.

Health & Personal Care
LOW
FDA DEVICE

Civco Medical Instruments Recalls 5 eTRAX Needle Sensor 12G for Aurora Trackers (2026)

Five Civco Medical Instruments eTRAX Needle Sensor 12G units for Aurora Trackers are recalled in the United States. The recall cites an inspection and programming error that could misidentify the needle tip position on the user interface. Healthcare providers should stop using the device immediately and follow recall instructions.

Civco Medical Instruments
There was
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Health & Personal Care
CRITICAL
FDA DEVICE

Philips Respironics Trilogy Evo O2 Ventilator Recall Affects 113,717 Units in 2026

Philips Respironics recalls 113,717 Trilogy Evo O2 home-use ventilators in 2026. The Obstruction Alarm may fail to trigger within required standards, delaying warning for airway obstruction for up to four breaths. Stop using the device and follow recall instructions from Philips or your clinician.

Philips Respironics
In some
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Health & Personal Care
HIGH
FDA DEVICE

Philips Respironics Trilogy Evo Ventilator Recall 2026 Affects 113,717 Units

Philips Respironics recalled 113,717 Trilogy Evo home-use ventilators worldwide after finding the Obstruction Alarm may fail to trigger, potentially delaying alerts by up to four breaths. The devices were distributed nationwide in the United States and internationally. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions.

Philips Respironics
In some
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Health & Personal Care
HIGH
FDA DEVICE

Philips Respironics Trilogy EV300 Recalled 113,717 Units Worldwide for Tidal Volume Discrepancy (202

Philips Respironics recalled 113,717 Trilogy EV300 ventilators sold worldwide through healthcare distributors on March 2, 2026. Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may cause a mismatch between the set tidal volume and the delivered tidal volume. Patients and healthcare providers should stop using the device immediately and follow the recall instructions from the 제조

Philips Respironics
Using non-pneumatic
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Health & Personal Care
HIGH
FDA DEVICE

Philips Respironics Trilogy EV300 Ventilator Recall Affects 113,717 Units in 2026

Philips Respironics recalled 113,717 Trilogy EV300 ventilators sold in the United States and internationally after determining the Obstruction Alarm may fail to trigger within required standards. The alarm can delay alerting caregivers for up to four breaths. Patients and healthcare providers should stop using the device immediately and follow recall instructions from Philips or their clinician.

Philips Respironics
In some
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Health & Personal Care
HIGH
FDA DEVICE

Olympus SOLTIVE Premium Laser System Recall Affects 408 Units Worldwide (2026)

Olympus recalls 408 SOLTIVE Premium Laser System units worldwide after a defect in the 24V power supply may render the system inoperable and cause smoke or a burning smell. The issue is contained within the internal console and would self-extinguish. Hospitals should stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Following a
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Health & Personal Care
HIGH
FDA DEVICE

Medline Angiography Kit Recall: 3,120 Medical Convenience Kits With NAMIC Adaptor May Disconnect (Z-

Medline Industries, LP recalls 3,120 medical convenience kits worldwide due to a risk the syringe rotating adaptor may unwind during use. The issue can create a loose connection or complete disconnection between the syringe and manifold. The recall was issued on February 27, 2026 and is active. Customers should stop using the kit and follow manufacturer instructions for recall notices.

Medline Industries, LP
Medline Industries,
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Health & Personal Care
HIGH
FDA DEVICE

Medline NAMIC Angiographic Rotating Adaptor Syringes Recalled in Class I Action for 79,843 Units

Medline Industries issued a Class I recall for 79,843 medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes. The action covers worldwide distribution including the US and PR. The risk is a syringe adaptor unwinding during use, which may cause a loose connection or disconnection with the manifold. Stop using the device immediately and follow recall instructions.

Medline Industries, LP
Medline Industries,
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Health & Personal Care
HIGH
FDA DEVICE

Medline NAMIC Angiographic Syringe Recall Affects 17,902 Kits Worldwide (2026)

Medline Industries, LP recalls 17,902 medical convenience kits worldwide after post-market surveillance found a potential risk of the syringe rotating adaptor unwinding. The recall covers NAMIC Angiographic RA control syringes labeled in 10 Medline SKUs. Healthcare providers should stop use immediately and follow recall instructions.

Medline Industries, LP
Medline Industries,
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Health & Personal Care
HIGH
FDA DEVICE

Medline NAMIC Angiographic Rotating Adaptor Syringe Recall Affects 762 Units Worldwide (2026)

Medline Industries, LP recalls 762 medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes sold worldwide, including the U.S., PR, Canada, and several international markets. The recall cites a potential risk that the syringe rotating adaptor may unwind during use, creating a loose connection or disconnect between the syringe and the manifold. Stop using the device and seek

Medline Industries, LP
Medline Industries,
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Health & Personal Care
HIGH
FDA DEVICE

Medline NAMIC RA Syringe Adaptor Recall Aims to Prevent Connection Failures in 60 Kits (2026)

Medline Industries, LP recalled 60 medical convenience kits worldwide due to a potential rotating adaptor unwinding in NAMIC Angiographic RA control syringes. The issue may cause a loose connection or disconnection between the syringe and manifold. Healthcare providers should stop using the device and follow the manufacturer’s recall instructions.

Medline Industries, LP
Medline Industries,
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Health & Personal Care
HIGH
FDA DEVICE

Medline NAMIC Angiographic Adaptor Syringe Recall Expands Worldwide in 240 Kits (Class I)

Medline Industries, LP recalled 240 medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes. The recall covers worldwide distribution including the US, Puerto Rico, and multiple international markets. The potential issue is the adaptor unwinding during use, risking a loose connection or disconnection with the manifold.

Medline Industries, LP
Medline Industries,
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Health & Personal Care
HIGH
FDA DEVICE

Medline NAMIC Angiographic Syringe Recall for 2,154 Kits Worldwide

Medline Industries, LP recalls 2,154 medical convenience kits worldwide after post-market surveillance found a risk that the NAMIC Angiographic Rotating Adaptor may unwind. A loose connection or disconnection between the syringe and manifold could occur. Stop using immediately and follow manufacturer recall instructions.

Medline Industries, LP
Medline Industries,
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Health & Personal Care
HIGH
FDA DEVICE

Medline NAMIC Angiographic Syringe Recalled Globally Over Rotation Adaptor Risk (2026)

Medline Industries, LP recalled 149,439 NAMIC Angiographic Syringes worldwide, including the US and several international markets. The post-market signal shows a potential rotation adaptor unwinding during use, which can cause a loose or complete disconnect with the manifold. Health care providers and patients should stop using the devices and follow Medline's recall instructions.

Medline Industries, LP
Medline Industries,
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Health & Personal Care
HIGH
FDA DEVICE

Medline NAMIC Angiographic Syringes Recalled Globally for Rotating Adaptor Unwinding Risk (Class I)

Medline Industries recalled 2,630,369 NAMIC Angiographic Syringes worldwide after post-market surveillance found a potential risk that the syringe rotating adaptor could unwind during use, causing a loose connection or disconnection with the manifold. Healthcare providers must stop using the device and follow recall instructions. Contact Medline or a healthcare provider for guidance.

Medline Industries, LP
Medline Industries,
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