FDA Class II Recall Watch: 20–26 September 2026

Official recall information

What happened

FDA posted four Class II recall records covering multiple urine and serum hCG rapid pregnancy-test configurations made by Alere San Diego. The tests may detect hCG concentrations below their stated assay sensitivity, which may produce false-positive results. FDA lists separate quantities of 50,265,835; 5,331,585; 13,256,075; and 18,139,960 across the four records, without specifying a quantity unit.

Official recall information

Official actions

According to the FDA recall records:

• For unexpected results, customers were instructed to consider the test limitations, including low hCG levels associated with peri-menopause, and to consider an alternate confirmatory test when making a pregnancy diagnosis.
• Customers that forwarded affected products to other laboratories were instructed to notify those laboratories and provide the field-corrective-action letter.
• Recipients were instructed to retain the letter and acknowledge receipt.

Official recall information

What happened

FDA classified the recall of specified NOxBOXi Nitric Oxide Delivery Systems as Class II because certain oxygen sensors may produce irregular oxygen readings due to a manufacturing issue. The affected devices are model NOXBOX-I and FDA lists 1,667 units in commerce. The recall covers specified serial numbers, with the FDA record listing U.S. distribution in Georgia.

Official recall information

Official actions

According to the FDA recall record:

• Distributors and device users were instructed to examine inventory for affected units and return the applicable response form.
• The firm instructed distributors to arrange replacement of affected oxygen sensors and perform preventive-maintenance checks before distributing units.
• Organizations were instructed to notify applicable personnel and customers that received affected units.

Official recall information

What happened

FDA classified the correction of Philips IntraSight Plus systems running software version 6.0.4 as Class II. The software may associate image data from one patient with another patient's record, potentially contributing to incorrect diagnosis or treatment. FDA lists 19 systems in commerce, with distribution in six U.S. states and several European countries.

Official recall information

Official actions

According to the FDA recall record:

• Customers were instructed to contact Philips service before changes to the worklist provider, Azurion software, interface configuration, or hospital IT environment.
• The notice was to be circulated to IntraSight Plus users and posted on or near the system until Philips updates the software.
• The FDA record states that the device may otherwise continue to be used according to its intended use.

Official recall information

What happened

FDA classified the EnCor EnCompass Breast Biopsy and Tissue Removal System correction as Class II. Software errors may cause probe-calibration, handheld-driver, or pressure-sensor failures, interrupting or prolonging a biopsy and potentially requiring additional sampling or a repeat procedure. FDA lists 99 affected products in commerce across multiple U.S. states.

Official recall information

Official actions

According to the FDA recall record:

• If probe calibration cannot be completed after troubleshooting, clinicians were instructed to replace the probe and, if necessary, use an alternative biopsy driver or system.
• If a pressure-sensor error cannot be cleared and normal operation restored, users were instructed to discontinue the affected system and complete or reschedule the procedure with alternative equipment.
• Facilities were instructed to post the correction notice near affected devices, make systems available for the software update, notify relevant users or downstream recipients, and return the response form.

Official recall information

What happened

FDA classified specified Embosphere Microspheres as a Class II recall because holes may be present in product packaging, potentially compromising the sterile barrier. The microspheres are used for embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels; FDA states that use of affected product could lead to infection. The record lists 104 affected products in commerce.

Official recall information

Official actions

According to the FDA recall record:

• Customers were instructed to discontinue use and return affected devices to Merit Medical.
• Organizations were instructed to make applicable personnel aware of the recall and immediately share the notice with facilities or institutions that received further-distributed product.
• Customers were instructed to complete and return the response form.

Official recall information

What happened

FDA posted five Class II recall records for Medline convenience kits containing neurological sponges with potential unexpected variability in endotoxin levels. The records span ENT, laparoscopy, general-surgery, neurological, and orthopedic tray classifications. Their reported quantities are compatible and total 5,556 kits. FDA states that potentially elevated endotoxin may cause neurovascular events, febrile response, inflammation, hypotension, or nausea.

Official recall information

Official actions

According to the FDA recall records:

• Customers were instructed to identify and quarantine affected kits and submit the recall response form, including affected inventory quantities.
• Medline stated that over-labels would be supplied instructing staff to remove and discard the affected neurological sponge before using the kit.
• Distributors and organizations that transferred affected kits were instructed to notify downstream customers and include their quantities on the response form.

Official recall information

What happened

FDA posted two Class II recall records for Halyard IV START kits containing BD ChloraPrep Clear 1 mL applicators that may have an open or incomplete packaging seal. An updated field correction also identified certain applicator lots contaminated with Aspergillus penicillioides. The two FDA records report compatible quantities totaling 1,008 kits, or 21 cases, distributed nationwide in the United States.

Official recall information

Official actions

According to the FDA recall records:

• For kits containing applicators affected by the contamination update, consignees were instructed to discard the impacted kits and notify customers that received them.
• For kits included for sterility concerns but not the contamination update, consignees were instructed to quarantine affected product, discontinue use of the affected applicator component, and apply a warning label directing users to discard that component.
• Customers were instructed to notify downstream recipients when affected kits had been further distributed.

Official recall information

What happened

FDA posted four Class II recall records for PALACOS pro bone-cement systems because of potential monomer-liquid leakage. The affected families include standard and antibiotic-loaded PALACOS R and MV configurations. FDA reports 33,727 units, 59,660 units, and 20,523 units for three records; the fourth record does not report a Quantity in Commerce. Distribution is worldwide, including the United States.

Official recall information

Official actions

According to the FDA recall records:

• Consignees were instructed to ensure relevant hospital departments received the correction letter and to wear suitable eye protection whenever the system is operated.
• If leakage is observed, users were instructed not to continue using the product and to discard it using additional precautions, including double gloves, according to hospital and local waste procedures.
• Consignees were instructed to complete and return the reply form and retain a copy for their records.