FDA Class II Recall Watch: 16–22 August 2026

Official recall information

What happened

FDA posted three Class II records for Medline neonatal and infant heated-wire breathing circuits after sporadic failures involving discoloration, melting, smoke, burning odor, or localized thermal damage at the humidifier connector. The records describe potential respiratory consequences including airway obstruction and worsening respiratory distress. FDA lists 416,951 units across the three records, distributed nationwide in the United States and in Panama.

Official recall information

Official actions

According to the FDA recall records:

• If connector overheating or thermal damage is observed, healthcare providers were told to assess the patient and ensure continued respiratory support.
• Affected circuits were to be replaced as soon as clinically appropriate and removed from service for investigation.
• An updated customer communication instructed consignees to destroy affected inventory.
• The FDA records state that corrected product distribution had begun.

Official recall information

What happened

FDA posted two Class II records for specified EMIT 2000 Quinidine Assay lots because unacceptable precision performance may produce erroneously elevated quinidine measurements. The FDA records state that this may create risk of suboptimal treatment, including potentially life-threatening cardiac arrhythmias or inadequate antimalarial therapy. The two records report 20 and 55 units respectively, totaling 75 units across the grouped recall records.

Official recall information

Official actions

According to the FDA recall records:

• Consignees were instructed to review the notification with their Medical Director and determine the appropriate course of action, including for previously generated results where applicable.
• Use of the affected kit lots was to be discontinued and the lots discarded.
• Customers were instructed to complete and return the Field Correction Effectiveness Check Form within 30 days.
• The notice was to be retained with laboratory records and forwarded to recipients that may have received the product.

Official recall information

What happened

FDA posted two Class II records covering DxC 500i and DxC 500 AU analyzer modules running software version 1.5 or lower. A Parameter Package import can overwrite previously modified predefined calculated-test rules, silently reverting them to default expressions and potentially generating erroneous patient results without an explicit error notification. The issue applies when a new Parameter Package is imported onto an existing configured system.

Official recall information

Official actions

According to the FDA recall records:

• Customers were advised not to change any of the 25 predefined calculated rules and to use the provided workflow when different calculations are required.
• Laboratories were instructed to determine whether predefined rules had previously been modified and, if so, configure them as custom calculated rules and disable the modified predefined rule.
• The notification was to be shared with the Medical Director to determine whether retrospective review of results is necessary.
• Customers were instructed to post the letter on or near affected analyzers.

Official recall information

What happened

FDA classified the recall of specified Veritas Standard Glenoid Baseplates as Class II because incorrect machining of a peripheral screw hole may prevent proper engagement of peripheral screws. The standard baseplate is used in the restor3d Reverse Total Shoulder Arthroplasty System; patient-specific baseplates are not included. FDA identifies six affected lots across two models and lists 59 affected products in commerce.

Official recall information

Official actions

According to the FDA recall record:

• Customers were instructed not to implant or otherwise use affected units.
• Affected unused units were to be quarantined and removed from implant sets, consignment inventory, shelves, and other storage locations.
• Customers were instructed to complete and return the Field Action Response Form within 10 business days.
• Affected glenoid baseplates were to be packaged and returned to restor3d using the provided prepaid shipping label.

Official recall information

What happened

FDA classified the recall of Merge PACS and Merge OrthoPACS software version 9.5 as Class II because a software issue may cause ultrasound measurements to display inaccurately. The field action affects 20 units distributed in five U.S. states. Merge instructed customers to identify potentially affected ultrasound studies, review measurements, and use a software update to eliminate the root cause.

Official recall information

Official actions

According to the FDA recall record:

• Customers were advised to contact Merge Healthcare Support to identify affected ultrasound studies and determine necessary next steps.
• Until the update is installed, ultrasound measurements made in the Merge PACS or OrthoPACS Viewer were to be confirmed against measurements acquired at the ultrasound modality.
• Merge Healthcare Support will assist customers with study review and schedule installation of the corrective software update.
• The notice was to be forwarded to individuals and affiliated parties that may need to be aware of the issue.

Official recall information

What happened

FDA posted four Class II records for Medline ENT, general surgery, neurological, and orthopedic convenience kits containing Pilling Wecksorb Neurosponges or Neurosponge Strips with potential out-of-specification endotoxin levels. The four records report 2,262, 246, 3,468, and 974 kits respectively, totaling 6,950 kits. The same component issue and customer actions apply across the grouped surgical-kit records.

Official recall information

Official actions

According to the FDA recall records:

• Consignees were instructed to check stock for affected item and lot numbers and quarantine affected product.
• Customers were instructed to submit the recall response form, including affected quantities held in inventory.
• After response submission, Medline would provide over-labels instructing staff to remove and discard the affected component before using the kit.
• Distributors or other recipients that resold or transferred affected product were instructed to notify their customers and provide the over-labels.

Official recall information

What happened

FDA classified Philips Incisive CT systems with software versions 4.5 and 5.0 as Class II because of the potential for failure to trigger the clinical scan during Bolus Tracking. The affected product codes are 728143 and 728144, with distribution throughout the United States and U.S. territories. Philips is addressing the issue through an Electronic Product Radiation Correction and a software update.

Official recall information

Official actions

According to the FDA recall record:

• Philips notified customers through an Electronic Product Radiation Correction communication.
• Philips stated that it will schedule appointments with customers to update the affected software free of charge.
• Customers seeking additional information or support were directed to their local Philips representative or the Philips Customer Care Solutions Center.

Official recall information

What happened

FDA classified the recall of specified Esteem Body Soft Convex Urostomy Pouches as Class II because the pouches may leak from the cap during use. The action covers multiple models and lots, with FDA reporting 617850 units in commerce and distribution across numerous U.S. states. ConvaTec's notification instructs users and distributors to identify affected product and control further use or distribution.

Official recall information

Official actions

According to the FDA recall record:

• Recipients were instructed to examine inventory and identify affected product lots.
• End users identifying affected product were told to discontinue use and seek replacement product; interim precautions were provided when replacement was not immediately available.
• Distributors were instructed to quarantine affected product and discontinue distribution, sale, transfer, and use.
• Recipients that had further distributed affected product were instructed to notify consignees and customers and provide the recall notification.
• Recipients were instructed to complete and return the acknowledgement form.