FDA Device Recalls (Class II)

Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall - 713,702 Units

Wilson-Cook Medical Inc. initiated a Class 2 recall of 713,702 units of the Instinct Plus Endoscopic Clipping Device (REF: G58010) due to potential device malfunction. The recall affects all lots manufactured between September 2, 2023 and April 20, 2025. Consignees are required to immediately cease use, quarantine affected devices, and return products to Cook Medical.

Clariance Elegance Anterior Cervical Plate Recall - 511 Units, Burr Defect

FDA classified a Class II recall of Clariance SAS Elegance Anterior Cervical Plate systems. The firm initiated the recall on February 20, 2026, after identifying a burr defect on finished cervical plate products. 511 units were distributed nationwide in California, Illinois, New York, and Texas. Customers are instructed to stop using affected devices, quarantine them, and return consigned stock.

React Health PHOENIX 5L Oxygen Concentrator Class II Recall

FDA classified a Class II recall for React Health PHOENIX 5L Oxygen Concentrators (Recall Number Z-1815-2026) distributed in New York. Two units with specific serial numbers (MZJ5S713971, MZJ5S714009) were recalled after failing to meet internal quality specifications due to storage issues. The firm notified its sole consignee on February 4, 2026 and sent a formal recall notification on March 5, 2026.

Class 2 Recall: Medtronic Paradigm Insulin Pump (73,656 Units)

Medtronic MiniMed has issued a Class II recall for 73,656 Paradigm Insulin Pumps (MMT-712, MMT-715) due to a device design flaw causing unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site. Insulin over-delivery can result in severe hypoglycemia, altered mental status, seizure, coma, or death, while under-delivery can cause severe hyperglycemia, diabetic ketoacidosis, or death. The recall was initiated on February 13, 2026, with customer notifications sent via email, SMS, certified mail, and in-app push notifications.

iLet ACE Pump Recall - Security Bypass Vulnerability, 15 Units

FDA Class II recall of Beta Bionics iLet ACE Pump and iLet Dosing Decision Software (15 units) due to security bypass vulnerability in Lock Screen and Limited Access Passcode Screen software versions 1.3.7, 1.4.2, and 1.4.3. Active icons in the status bar allow unauthorized users to bypass security screens and make meal announcements or stop insulin delivery, posing risk of severe hypoglycemia. Firmware update to latest version required.

Remel Yeastone Broth Class II Recall - 10 Affected Lots

FDA classified a Class II recall of Remel Inc.'s Yeastone Broth (11ML) susceptibility test plates due to potential reporting of incorrect AST results during quality control. The recall affects 10 lots distributed to US and 10 countries (2819 units total). Health consequences may include delayed treatment response or need to change antifungal agents if laboratories ignore QC test results. Consignees must destroy remaining inventory and assess whether retesting of previously reported results is appropriate.

Philips AneurysmFlow Software Class II Recall - Model 001015

FDA initiated Class II recall Z-1805-2026 for Philips AneurysmFlow software (Model 001015, Software Version R1.x), a radiological image processing system intended for use with Philips interventional X-ray systems and 3DRA data. The firm initiated the recall on March 19, 2026. Affected products include numerous UDI numbers spanning multiple product codes.