FDA Class II Recall Watch: 23–29 August 2026

Official recall information

What happened

FDA posted two Class II records under event 99404 for Midmark IQecg and Digital ECG systems using IQecg Plugin versions starting with v10 and before v10.1.0.18. A communication anomaly may produce incorrect electrocardiogram waveforms and an inaccurate beats-per-minute calculation. FDA states that the reported 3,624-unit quantity is combined across the IQecg and Midmark Digital ECG systems.

Official recall information

Official actions

According to the FDA recall records:

• Until corrected software is installed, Midmark recommends a manual clinical assessment of heart rate when ECG tracings reflect tachycardia before therapeutic intervention.
• Users encountering the issue were directed to follow the temporary workaround instructions provided in the notification.
• Midmark will contact facilities to verify installed IQecg Plugin versions and coordinate the software correction.

Official recall information

What happened

FDA posted four Class II records under event 99536 for GE Healthcare Portrait Core Services software configurations. The software issue may cause loss of patient monitoring at the Hub and Central Viewer, and alarm settings may reset to factory defaults after an update rather than retain configured patient or care-area settings. FDA reports quantities of 23 units, 4 units, 15 units, and 0 across the four records.

Official recall information

Official actions

According to the FDA recall records:

• Affected Portrait systems may continue to be used.
• Facilities were instructed to establish appropriate alternative monitoring before a software update is started.
• Facilities were instructed to place the supplied User Manual addendum with the Portrait system documentation.
• Potential users were to be made aware of the safety notification and recommended actions.

Official recall information

What happened

FDA classified the correction of specified Fresenius 2008T BlueStar Hemodialysis Machines as Class II after the firm received complaints involving flow-, no-water-, or temperature-related alarms. The affected products are models 191126 and 191130. FDA lists 1140 systems in commerce with nationwide U.S. distribution, and Fresenius is arranging replacement of affected parts through its technical-service organization.

Official recall information

Official actions

According to the FDA recall record:

• Affected machines in use without error messages may continue to be used until the parts are replaced.
• If an affected machine develops flow-, no-water-, or temperature-related alarms, facilities were instructed to use a backup machine until parts are replaced.
• Parts on affected machines not yet installed at clinics are to be replaced before installation.
• Facilities were instructed to contact Fresenius technical service to schedule the update.

Official recall information

What happened

FDA posted two Class II records under event 99596 for IMRIS ORT200 and ORT300 operating tables. The linear actuator and rotational-lock mechanism may mechanically fail, preventing transition between locked and unlocked states and creating a risk of unintended rotational movement during a procedure. FDA lists 6 ORT200 units and 13 ORT300 units, totaling 19 units across the two records.

Official recall information

Official actions

According to the FDA recall records:

• Facilities were instructed to test affected tables daily in standard positions and inspect for anomalies.
• During use, staff were instructed to verify that the table is locked by manually checking for rotational movement.
• If the floor-latching mechanism does not function properly, facilities were instructed to contact IMRIS Customer Service.
• IMRIS field service will replace the linear-actuator and rotational-lock components with an updated design.

Official recall information

What happened

FDA classified Canon Medical's correction of specified Alphenix interventional fluoroscopic X-ray systems as Class II because fixing screws in the ceiling-movement gear of the ceiling-suspended arm may become loose. Abnormal noise or sensor errors can indicate loosening. FDA lists 10 affected systems distributed in eight U.S. states, and Canon plans to inspect screw tightening and attachment through field service.

Official recall information

Official actions

According to the FDA recall record:

• If abnormal noise occurs or a sensor error is displayed before correction, customers were instructed to stop using the device and contact Canon service.
• Facilities were strongly requested to share the notice with users and clinical engineering or biomedical personnel.
• Canon representatives will contact customers to schedule inspection of screw tightening and proper attachment.

Official recall information

What happened

FDA classified FUJIFILM Synapse PACS software v7.4.310 as a Class II recall because a software issue may make ruler measurements inaccurate. The affected radiological image-processing system has six units in commerce, distributed in five U.S. states and Australia. FUJIFILM provided awareness instructions and a workaround allowing M-mode ruler measurements to be performed on the ultrasound system before study transfer.

Official recall information

Official actions

According to the FDA recall record:

• Customers were instructed to post the notification on or near the Synapse PACS workstation.
• Customers were instructed to complete and return the Field Action Verification Form.
• Customers were directed to contact the Technical Assistance Center to open a service ticket.
• The notice describes performing M-mode ruler measurements on the ultrasound system and transferring the study to Synapse PACS as a workaround.

Official recall information

What happened

FDA posted three Class II records under event 99469 for Halyard medical convenience kits manufactured by Avid Medical. The kits contain specified Ritmed non-sterile neurological sponges recalled because of potential unexpected variability in endotoxin levels. FDA reports 11,763 general-surgery kits, 16,223 neurological kits, and 816 orthopedic kits, totaling 28,802 kits across the three records.

Official recall information

Official actions

According to the FDA recall records:

• Consignees were instructed to identify, segregate, and quarantine impacted product.
• Recall labels were to be added to affected Avid kits so users would discard the impacted component.
• Distributors that further distributed affected kits were instructed to notify end users and maintain effectiveness records.

Official recall information

What happened

FDA posted two Class II records under event 99537 for Healthmark ProChek protein cleaning-process indicators. The tests were manufactured with an expired ingredient that may present as either a false-negative or false-positive result. FDA reports 5,090 units for ProChek-II and 53 units for ProChek-W/ProChek-Semi Quantitative, totaling 5,143 units across the two recall records.

Official recall information

Official actions

According to the FDA recall records:

• Facilities were instructed to ensure affected product is no longer in use and is properly quarantined.
• The notice was to be forwarded to relevant individuals and organizations that received transferred product.
• Customers were instructed to contact Healthmark Customer Service to return unused affected product.
• Customers were instructed to complete the Customer Response Form.