US Food and Drug Administration recall notices, device corrections, and alerts provide information about products that may require changes in clinical use, inventory management, or patient care processes. The following 10-item framework summarizes the agency's recent actions involving medications and medical devices used in hospital, outpatient, home care, and procedural settings.

1. Fentanyl Citrate Sterile Injection Recall — IntegraDose Compounding Services initiated a voluntary Class II recall involving one lot of fentanyl citrate sterile CADD injection. According to the US Food and Drug Administration (FDA) enforcement report, the recall was issued because of a subpotent drug. The affected lot was distributed nationwide.

2. Automated Impella Controller Correction — Abiomed issued a Class I device recall involving certain Automated Impella Controllers running software versions 8.2.2 through 8.5. According to the recall notice, the "Purge System Blocked" alarm display could be delayed when the controller is used with first-generation Impella 5.5 pumps. Abiomed instructed customers to cease use of the Automated Impella Controller with an Impella 5.5 S1 pump unless the controller software has been updated to version 10.1 or later.

3. Insulet Insulin Pump Recall — Insulet issued a Class I recall of certain Omnipod 5 Pods after identifying a small tear that may occur in the internal tubing that delivers insulin. According to the FDA, the issue may result in underdelivery of insulin and a greater risk of elevated blood glucose levels. The company advised users to stop using Pods from affected lots, replace any affected Pod currently in use with one that is not affected by the recall, and contact Insulet for replacement devices. On April 10, 2026, Insulet expanded the list of affected Pod lots to include expired Pods. As of April 17, 2026, the company had reported 29 serious injuries associated with the issue and no mortality.

4. Baxter Positive Pressure Breathing Device Recall — Baxter issued a Class I recall involving the Blue Ventilator Adapter Module used with the Baxter Volara Respiratory Therapy System. According to the FDA recall notice, the correction provided updated instructions for use in home care settings. Baxter instructed users to continue therapy as prescribed, review the updated instructions for use, monitor for signs of respiratory distress during treatment, and seek medical attention if symptoms do not improve.

5. Philips Trilogy Evo Ventilator Recall — Philips issued a Class I recall involving Respironics Trilogy Evo O2 ventilators running software version 1.05.15.00. According to the FDA recall notice, use of nonpneumatic nebulizers with the Trilogy Evo platform ventilators may result in a difference between the set tidal volume and the tidal volume delivered to the patient. Philips instructed customers to update affected devices, stop using nonpneumatic nebulizers with affected ventilators and review the updated user manual addendum.

6. React Health VOCSN V+Pro Ventilator Recall — React Health recalled certain VOCSN V+Pro ventilators because of a manufacturing deviation that may result in an undetected oxygen leak. According to the FDA recall notice, an oxygen leak may result in the delivery of fraction of inspired oxygen concentrations below intended levels during ventilation and increase the fire risk in oxygen-enriched environments. React Health instructed customers to discontinue use of affected devices, remove them from clinical service, and use a nonaffected ventilator for patient support.

7. Boston Scientific AXIOS Stent Recall — Boston Scientific issues a Class I recall for certain AXIOS Stent and Electrocautery-Enhanced Delivery Systems following increased reports of stent deployment and expansion issues. According to the FDA, the issue occurs during stent delivery and does not affect stents that have been successfully implanted. The company instructed customers to stop using and distributing the affected products, remove the remaining inventory from use, and return the affected devices. As of December 23, Boston Scientific had reported 167 serious injuries and 3 mortalities associated with the issue.

8. Arrow Dialysis Catheter Kit Recall — Arrow International issued a Class I recall of certain dialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable Sheath Introducers. According to the FDA recall notice, the sheath introducer may not split as intended because of a design defect. Arrow International instructed customers to stop using and distributing the affected kits and return them to the company.

9. BD Spinal Tray Correction Involving Bupivacaine — Becton Dickinson issued a correction involving certain BD spinal trays containing bupivacaine ampules manufactured by Huons Co. According to the FDA communication, the ampules were recalled following quality issues identified during an FDA inspection and limited reports of drug ineffectiveness. Becton Dickinson instructed customers not to use the bupivacaine ampules contained in the affected trays, remove and discard the ampules when opening the kit, and secure an alternative source of bupivacaine prior to procedures. The company stated that all other components in the affected trays may continue to be used.

10. GE HealthCare Infant Resuscitation System Early Alert — GE HealthCare issued an early alert involving certain infant resuscitation systems and warmers equipped with an M1091607-R blender. According to the FDA communication, the shaft of the air-oxygen blender knob may loosen, which can affect the oxygen concentration delivered by the device. GE HealthCare instructed customers to identify affected systems, remove them from patient use until corrected, and evaluate inventory for the affected blenders.

Source: FDA