FDA Class II Recall Watch: 9–15 August 2026

Official recall information

What happened

FDA classified one BIOFIRE Respiratory Panel 2.1 lot as Class II after complaints of false-negative results. BioFire's investigation found incorrect PCR1 primers in a subset of pouches, allowing pathogen assays to return negative while control assays passed. The affected scope is kit lot 1872125 / pouch lot 3VLB25, totaling 2,370 pouches, or 79 kits.

Official recall information

Official actions

According to the FDA recall record:

• Customers were instructed to examine inventory for the affected lot and cease use and discard remaining product.
• Customers were instructed to document quantities destroyed, previously used, or returned on the acknowledgement form.
• Customers that further distributed the product were instructed to identify recipients and notify them at once.
• BioFire stated that pouch credit would be provided for affected product.

Official recall information

What happened

This editorial entry combines two closely related FDA Class II Azurion recall records covering R2.2.10 and R3.0/R3.1 software. Both describe potential image-quality degradation that may contribute to delayed therapy, procedural complications, or inappropriate treatment, plus potential loss of geometry movements. FDA lists 10,872 units for R2.2.10 and 2,016 units for R3.0/R3.1, totaling 12,888 units across the two recall records.

Official recall information

Official actions

According to the FDA recall records:

• If image-quality degradation is observed, users were instructed to perform the specified cold restart when clinically feasible.
• If geometry movement is lost, users were instructed to restart geometry using the specified emergency-stop and power-on sequence.
• Facilities were instructed to distribute the notice to relevant users and post it near affected devices where applicable.
• Consignees were instructed to complete and return the response form to Philips.

Official recall information

What happened

FDA classified BD's recall of three intravascular extension-set configurations as Class II after a mechanical issue with internal sterilization equipment created potential underdosing during processing. FDA states that affected products may not have been sterilized correctly. The recall covers three specified lots, and FDA lists 93,700 affected products in commerce across multiple U.S. states and Canada.

Official recall information

Official actions

According to the FDA recall record:

• Customers were instructed to immediately discontinue use of affected lots and check all inventory locations.
• Affected units were to be destroyed, or quarantined until disposal if immediate destruction was not possible.
• Product already in use was to be replaced with non-impacted product as soon as possible.
• Customers were instructed to notify downstream facilities and return the Customer Response Form to BD.

Official recall information

What happened

FDA posted eight Class II records under event 99380 for Cardinal Health Presource Kits containing affected Ritmed neurological sponges. Cardinal Health had been informed of a supplier recall involving unexpected variability in endotoxin levels. The records span numerous surgical kit configurations and total 579,808 kits across the eight records, with distribution in the United States and Canada.

Official recall information

Official actions

According to the FDA recall records:

• Consignees were asked to notify clinicians about the affected kits.
• Consignees were instructed to affix warning labels to affected kits in inventory.
• The warning label directs removal and disposal of the affected neurological sponge component.
• Consignees were instructed to return the acknowledgement form, and distributors were directed to notify their customers.

Official recall information

What happened

FDA classified two ProNephro AKI (NGAL) Reagent Kit lots as Class II because assay reagents underwent a non-validated rework process. The FDA record states that the issue could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate disease monitoring. The affected scope covers lots 04909125 and 04912125, with 400 units in commerce.

Official recall information

Official actions

According to the FDA recall record:

• U.S. consignees were instructed to coordinate replacement of affected devices.
• Consignees outside the United States were instructed to scrap unopened kits in accordance with local requirements and request replacements.

Official recall information

What happened

FDA classified the ERBECRYO 2 correction as Class II. A strong pull on the unit's high-pressure transfer hose may create a pneumatic short circuit, allowing carbon dioxide into the return path and excessive pressure that can rupture the cryoprobe. The affected scope includes serial numbers through 11608268 running software version 1.0.3, with 11,226 units in commerce.

Official recall information

Official actions

According to the FDA recall record:

• Facilities were asked to make affected ERBECRYO 2 units available for an Erbe representative to install software version 1.0.4.
• Facilities were instructed to confirm acknowledgement with the Erbe representative on site.
• The notice was to be shared with all users within the facility.
• Pending the update, users were told to continue following the existing warnings, instructions, and guidelines for the unit and cryoprobe.

Official recall information

What happened

FDA classified the Allura Xper correction as Class II because a firmware issue may lead to loss of geometry movements. The recall covers eight listed model numbers and 4,252 units distributed worldwide. Philips' correction plan calls for software version R8.2.102.1 on affected systems, while the FDA record provides interim instructions for restarting geometry if the issue occurs.

Official recall information

Official actions

According to the FDA recall record:

• Consignees were given instructions to identify affected systems and table configurations and to restart geometry if the issue occurs.
• Facilities were instructed to distribute and retain the notification and post it near affected devices.
• Recipients were instructed to notify downstream organizations if affected systems had been transferred.
• Philips stated that a local representative would schedule implementation of software update R8.2.102.1 when available.

Official recall information

What happened

FDA classified Terumo's recall of GLIDESHEATH SLENDER A-KIT lot 0001441871 as Class II because the product was packaged with a 0.025-inch guidewire instead of the specified 0.021-inch guidewire. The sheath facilitates catheter placement through the skin into the radial artery. FDA reports 7,490 units in commerce, with U.S. nationwide and Canadian distribution.

Official recall information

Official actions

According to the FDA recall record:

• Consignees were instructed to immediately isolate affected lot 0001441871.
• Affected units were to be returned.
• Facilities or customers that received further-distributed affected units were to be notified.
• Consignees were instructed to complete and return the provided response form.