FDA Class II Recall Watch: 30 August–5 September 2026

Official recall information

What happened

FDA posted four Class II recall records for Fresenius 5008X blood tubing sets after identifying a heightened probability of blood leakage at the connection between the Arterial Alpha Clip and the main line or pump segment. A leak during hemodialysis may cause blood loss and hypovolemia. Because one FDA quantity lacks a stated unit, the four official quantities are preserved separately rather than aggregated.

Official recall information

Official actions

According to the FDA recall records:

• Customers were instructed to identify affected product on hand and immediately segregate and discontinue use of affected lots.
• Customers were instructed to contact the designated call center for return of affected lots and replacement stock.
• Customers were instructed to complete and return the included reply form.

Official recall information

What happened

FDA posted two Class II recall records for Baxter Novum IQ Syringe Pumps covering standard and loaner models. The software issue can occur during a Volume/Time multi-syringe infusion when an empty syringe is replaced while a Volume To Be Infused remains. FDA reports 14,601 standard pumps and 4 loaner pumps, totaling 14,605 units across the two records.

Official recall information

Official actions

According to the FDA recall records:

• Customers were advised to use the same compatible syringe model, brand, and size for all syringes required within a multi-syringe Volume/Time workflow.
• Customers were provided additional instructions for situations in which a syringe does not support the intended flow rate after a syringe change.

Official recall information

What happened

FDA classified the recall of the VELYS Enabling Tech Robotic-Assist Station as Class II after a software issue in the robotic controller was identified that may cause unintended robotic-arm movement during bone preparation or instrument positioning. The affected scope is 29 stations distributed across multiple U.S. states. The associated navigation and camera stations may continue to be used under the notice.

Official recall information

Official actions

According to the FDA recall record:

• Consignees were instructed not to use the VELYS Robotic-Assist Station and to quarantine it immediately.
• The VELYS Navigation Station and VELYS Camera Station may continue to be used according to their instructions for use.
• Consignees were instructed to complete and return the business response form and forward or post the notice for relevant personnel.

Official recall information

What happened

FDA posted three Class II records for LATITUDE Clarity server software supporting the LUX-Dx family of insertable cardiac monitors. The software can delay AF Burden Alert notification when a non-default threshold is configured above zero hours per day, which may delay clinical evaluation or therapeutic intervention for an atrial arrhythmia. The implanted monitors continue detecting, storing, and transmitting data.

Official recall information

Official actions

According to the FDA recall records:

• Until updated server software is available, customers may mitigate the delay by changing the AF Burden Alert threshold or enabling AF Events alerts with a minimum duration.
• Boston Scientific does not recommend replacement of the implanted insertable cardiac monitor.
• Customers were asked to share the notification with healthcare professionals managing patients through the LUX-Dx and LATITUDE Clarity system.

Official recall information

What happened

FDA posted three Class II records for specified GranuFlo, NaturaLyte, and Citrasate hemodialysis concentrate lots following complaints of blue-green product discoloration. FDA identified the cause as material or component contamination. Because the records use multiple quantity units, including cases, eaches, and drums, the official quantities are preserved by product rather than combined into a single total.

Official recall information

Official actions

According to the FDA recall records:

• Customers were instructed to identify affected lots on hand and immediately segregate and discontinue use of those lots.
• Customers were instructed to contact Fresenius for return of affected lots and replacement stock.
• Customers were instructed to complete and return the attached reply form.

Official recall information

What happened

FDA posted four Class II recall records covering Philips Brilliance iCT, IQon Spectral CT, Ingenuity CT, and Brilliance CT 64 systems. Philips identified an unintended radiation issue that could affect equipment performance. The records share the same FDA Event ID, recall reason, customer correction, and posting date, so the four closely related CT product records are grouped into one editorial entry.

Official recall information

Official actions

According to the FDA recall records:

• Philips is informing customers through an Electronic Product Radiation Correction notification.
• Philips will schedule appointments with remaining customers to update affected system software free of charge.
• Customers needing additional information or support were directed to their local Philips representative or customer-care center.

Official recall information

What happened

FDA posted ten Class II records for Medline convenience kits containing specified BD ChloraPrep Clear 1mL Applicators. The component supplier recalled affected applicators because packaging may have an open or incomplete seal, creating contamination and infection concerns. Each FDA record repeats the same Quantity in Commerce value of 222,653 total, so that event-level figure is preserved once rather than multiplied across records.

Official recall information

Official actions

According to the FDA recall records:

• Medline instructed customers to request stickers to over-label affected convenience kits.
• The over-label instructs users to remove the affected ChloraPrep component and replace it with product from supply.
• The FDA records state that the affected convenience kits are not to be returned.

Official recall information

What happened

FDA classified a correction involving HEALON EndoCoat PRO and HEALON DUET PRO II as Class II. The notice clarifies insertion technique because forcing the cannula when resistance is encountered may increase the risk of tissue injury, including corneal abrasion, iris trauma, or Descemet's membrane detachment. FDA lists 111,478 affected products in commerce across U.S. and international distribution.

Official recall information

Official actions

According to the FDA recall record:

• Users were instructed to withdraw the cannula and reassess insertion conditions if resistance is encountered rather than forcing insertion.
• Customers were instructed to forward the notice to surgeons using the device and to other facilities or surgeons that received affected product.
• Customers were instructed to keep a copy of the notice with affected product and return the business reply form.