FDA Class II Recall Watch: 28 September–4 October 2026

Official recall information

What happened

FDA classified the recall of Pipeline Flex Embolization Device with Shield Technology lot D112860 as Class II because devices labeled as 3.00 mm diameter contain 2.50 mm diameter implants. The product is a permanent intracranial aneurysm flow-diverter implant with a guidewire-based delivery system. FDA lists a Quantity in Commerce of 2, without a stated unit, distributed in Georgia and Texas.

Official recall information

Official actions

According to the FDA recall record:

• Customers were instructed not to use affected devices and to remove and quarantine unused affected product.
• Affected product was to be returned to Medtronic, with replacement support available through the Medtronic representative.
• Customers were instructed to review records for patients treated with the affected lot and assess whether follow-up is appropriate.
• Customers were instructed to complete the confirmation form and share the recall communication with other affected organizations.

Official recall information

What happened

FDA classified Tandem's beta t:slim mobile application version 2.13 for iOS as Class II after a software issue prevented pairing with Abbott FreeStyle Libre 3 Plus sensors. Affected users may lose CGM values in the app and automated closed-loop operation, requiring manual pump use and potentially contributing to hypoglycemia or hyperglycemia. FDA lists a Quantity in Commerce of 177, without a stated unit.

Official recall information

Official actions

According to the FDA recall record:

• Customers were advised to discontinue use of iOS t:slim mobile application version 2.13.
• Customers were instructed to uninstall version 2.13 from their mobile device.
• Customers were instructed to return to production version 2.12.1 from the Apple App Store.
• Users were instructed to scan a compatible FreeStyle Libre 3 Plus sensor with version 2.12.1 when starting the next sensor session.

Official recall information

What happened

FDA classified the Quantum PureFlow Standard Heat Exchanger High Flow 3/8 recall as Class II following blood-to-glycol leakage between compartments during cardiopulmonary bypass. The single-use device heats or cools circulating blood through a compatible heater-cooler. The recall covers model HX55W-S0, lot 18051160301178. FDA lists 3232, without a quantity unit, and identifies process design as the cause.

Official recall information

Official actions

According to the FDA recall record:

• Users were instructed to monitor the heat exchanger during procedures for a color change in the glycol compartment indicating leakage.
• If leakage is observed, the heat exchanger should be immediately replaced in the circuit and returned to Spectrum Medical.
• Remove a contaminated heater-cooler from clinical use and return it for decontamination and inspection; do not use it with another patient.
• Customers using a third-party heater-cooler were instructed to remove it from clinical use and contact its manufacturer if blood contamination occurs.

Official recall information

What happened

FDA classified a Philips Spectral CT 7500 correction as Class II because the Bolus Tracking scan application may crash and Bolus Tracker shots may continue after the contrast threshold is reached. FDA states that this can result in additional radiation exposure to the patient. The affected configuration uses software version 5.2.x, and FDA lists a Quantity in Commerce of 62, without a stated unit.

Official recall information

Official actions

According to the FDA recall record:

• Philips issued an Electronic Product Radiation Correction notification describing actions intended to prevent patient risk.
• Philips stated that it will schedule appointments with affected customers to install a software solution free of charge.

Official recall information

What happened

FDA classified Siemens' Atellica CH Revised C-Reactive Protein assay recall as Class II because of the potential for falsely elevated results. The recall applies to all lots of Siemens Material Number 11537223. FDA reports 42940 units in commerce, including 3938 in the United States and 39002 outside the United States, with worldwide distribution and the cause still under investigation.

Official recall information

Official actions

According to the FDA recall record:

• Customers were instructed to follow the supplied instructions to set up and calibrate the device.
• Customers were instructed to record unused tests discarded for reimbursement or credit.
• Laboratories were instructed to review the letter with their Medical Director and determine the appropriate course of action, including for previously generated results if applicable.
• Return the Field Correction Effectiveness Check Form within 30 days, retain the letter with laboratory records, and forward it to recipients of affected product.

Official recall information

What happened

FDA posted five Class II records under event 99704 for STERIS VERIFY biological indicators, test packs, and challenge packs. The Geobacillus stearothermophilus spore population may fall below the minimum shelf-life specification, potentially producing a no-growth result even when the steam cycle did not achieve the intended spore reduction. FDA reports record-level quantities of 409, 1185, 2205, 217, and 233 without stated units.

Official recall information

Official actions

According to the FDA recall records:

• Customers were instructed to destroy any affected product remaining on hand.
• STERIS stated that it will replace affected product that is still within its shelf life.

Official recall information

What happened

FDA posted a separate Class II Philips Spectral CT correction on October 2. Unlike the September 29 radiation-control recall, this event concerns software issues that may produce image artifacts, wrong slice thickness, or unintended system motion across Spectral CT and Spectral CT 7500 RT configurations. FDA lists a Quantity in Commerce of 539, without a stated unit, with worldwide distribution.

Official recall information

Official actions

According to the FDA recall record:

• Customers were told they may continue using affected systems in accordance with their intended use.
• Facilities were instructed to circulate the notice to all users so they are aware of the issues, potential hazards, and manufacturer recommendations.
• Facilities were instructed to post the notice near affected units until a solution is installed.
• Customers were instructed to complete and return the response form within 30 days.

Official recall information

What happened

FDA classified the ADAPTABLE Beach Chair surgical patient positioner recall as Class II because an inadequate weld in the patient head-positioning system can fracture below the head rest. The firm received complaints describing welded-joint fracture and head-rest separation. FDA lists a Quantity in Commerce of 266, without a stated unit, distributed in California and Texas, and identifies device design as the determined cause.

Official recall information

Official actions

According to the FDA recall record:

• Customers were instructed to locate affected devices and perform the specified safety check.
• Devices that pass the safety check may remain in clinical use pending exchange for an upgraded unit.
• Devices that fail the safety check must be segregated and removed from use, with return and replacement arranged.
• Notify staff and organizations that received the product. Maintain awareness until actions are complete; return the acknowledgement or reply form even if no affected product is found.