ICU Medical recalled 64,290 spinal tray syringes on December 19, 2025, due to potential cracks in the syringe collar. The cracks may cause blood leakage and delays in blood draws or fluid delivery. Affected syringes were distributed nationwide across 13 states.
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall involves Portex Spinal Tray syringes, Item No. A3729-24 and A3595. The affected lots include A3729-24 UDI-DI 30351688075691 (Lot 6146204) and A3595 UDI-DI 35019517108211 (Lot 6157980). The syringes were distributed in California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas, and Washington.
Affected syringes may have cracks that can lead to blood leakage during arterial blood sampling or fluid delivery. These leaks can cause significant complications for patients requiring precise medical procedures.
There are no reported injuries or deaths at this time. The recall is classified as Class II due to the potential for serious consequences from the malfunction.
Stop using the syringes immediately. Contact ICU Medical Inc. or your healthcare provider for further instructions. Follow the recall instructions provided in the notification letter.
For more information, contact ICU Medical at their official website or through their customer service line. Detailed recall information is available at the FDA's enforcement report page.
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