Recall Roundup: FDA medical device recalls during October

Welcome to Recall Roundup, where we’ll keep you updated on medical device recalls that the FDA has reported over the last month.

FDA recalls occur when a device is deemed defective or (potentially) poses a health risk and either an issue needs to be corrected or the device needs to be removed from the market altogether. There are multiple types of recalls, from Class I to Class III, with Class I being the most serious. Class I recalls mean the defect poses a high risk of serious injury or death.

The agency posts a list of the most serious recalls on its website after the manufacturer takes action. During October, the FDA posted 11 Class 1 medical device recalls on its page, including the following.

BLUselect, BLUgriggs, and BLUperc tracheostomy tube kits: Smiths Medical on June 13 told customers to throw out all affected kits due to a manufacturing defect that could cause inadequate ventilation and lead to aspiration and death. As of October 25, the defect has been linked to 12 injuries, but there are no reported deaths, the FDA reported.

Giraffe OmniBed and Giraffe Omnibed CareStation: GE HealthCare and subsidiary Datex-Ohmeda updated instructions on September 3 following reports that the warming heater doors for this combination neonatal infant incubator and warmer can become loose. As of October 31, there have been no injuries or deaths reported, the FDA shared.

Ivenix Infusion System large volume pump software: The FDA reported that though as of October 1 there have been no injuries or deaths on record, this infusion pump’s software has issues that could cause a delay or underdosage of therapy. Fresenius Kabi urged users to update the software on August 30.

Jaco assistive robotic arm: On August 19, Kinova issued a correction, warning that this robotic arm could pose a fire hazard if the coating is damaged and comes into contact with an electric wheelchair that has electrical leakage. There have been no reports of injuries or deaths as of October 25, the FDA said.

Neo-Tee T-piece resuscitator: The FDA posted that though as of October 7 there have been no reported injuries, a malfunction with this resuscitator could prevent oxygen from getting to patients, potentially leading to injury or death. Mercury Medical notified customers to stop using this product on September 4 due to a risk of the inline controller coming apart.

Life2000 ventilation system: Baxter Healthcare updated use instructions on September 12 for this ventilation system because there’s a risk that the ventilator won’t alert users to low gas pressure, which could lead to shortness of breath, low levels of oxygen, or death. As of October 24, there’s been one reported injury and no deaths, the FDA reported.

MiniMed 630G, 670G, 770G, and 780G insulin pumps: Medtronic warned users on July 31, then again on October 4, that these portable insulin pumps may have “significantly” lower battery life and display incorrect information about how much battery life is left. The company recommended contacting its support team if battery life changes, the FDA said as of October 17. Medtronic has received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis from January 2023 to September 2024, but no reports of death.

Obsidio conformable embolic: As of October 18, there have been 15 reported injuries and four deaths as a result of gastrointestinal bleeding linked to this vascular embolization device, the FDA shared. Boston Scientific updated use instructions on October 11.

Phasitron 5 in-line valve: The FDA reported that as of October 2, six patients have been reported injured from this intrapulmonary percussive ventilation device after users did not take off a protective blue plug before therapy. Sentec/Percussionaire sent out updated instructions on September 3. No deaths connected to this device have been reported.

Trilogy Evo, EV300, EvoO2, and Evo Universal: On July 16, manufacturer Philips Respironics recommended users take actions including an immediate software update following nine reported injuries and one death due to issues with these ventilators, including an error where the patient receives less oxygen than displayed, the FDA reported as of October 1.

Z-800, Z-800F, Z-800W, and Z800WF infusion pumps: Manufacturer Zyno Medical asked customers in a September 13 letter to stop using these infusion pumps and return them for a software update, the FDA reported as of October 15. These infusion pumps may allow dangerously large air bubbles to enter a patient’s bloodstream. There have been two injuries and no deaths reported.