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Siemens has identified a potential issue with the Display ceiling suspension (DCS Fix XL) component on ARTIS icono ceiling systems. Over time, screws that secure the monitor to the suspension may gradually loosen, which could affect the stability of the mounted display.

Moderate·FDA·Jul 8, 2026

RayCare 2024A SP1 oncology information system has a software issue where beam set delivery notes can lose data if modified at the same time or updated during an active treatment session. Users may not be notified when these changes occur, potentially affecting treatment records.

Moderate·FDA·Jul 8, 2026·Raysearch Laboratories2 products

Some Medela ENFit ExSet enteral extension sets contain incorrect connectors that may not attach properly to ENFit connections. This incompatibility could cause a slight delay in delivering nutrition or medication through the feeding tube.

Moderate·FDA·Jul 8, 2026·Medela Inc

In some cases, the collimator (a precision component) may not fully dock into the Cyberknife treatment system. This triggers a safety interlock that blocks motion from the operator console. However, if staff enter the treatment room and use the in-room control pendant to move the system, the collimator can release and fall from its housing, creating a potential impact hazard.

Moderate·FDA·Jul 8, 2026·Accuray Incorporated

Siemens is recalling three models of its ARTIS icono imaging systems, 234 units in total, because the detector lift may stop moving after it is adjusted to its highest or lowest height limit. No injuries have been reported.

Moderate·FDA·Jul 8, 20263 products

In some cases, the collimator (a precision component) may not fully dock into the Cyberknife system. If operators bypass the safety interlock by using the in-room control pendant, the collimator can release and fall from the machine housing. This affects 48 Cyberknife units worldwide running software version 11X or earlier.

Moderate·FDA·Jul 8, 2026·Accuray Incorporated

Pilling Wecksorb Neurosponges—sterile cotton sponges used during brain and spine surgery—may contain higher-than-safe levels of endotoxins (bacterial toxins). The affected sponges were manufactured between 2021 and 2024. No injuries have been reported, but elevated endotoxins could trigger an inflammatory response during surgery.

Moderate·FDA·Jul 8, 2026·TELEFLEX LLC

The Adapter for Head Positioning (Model 1739994) used with Baxter operating tables may become loose during patient positioning and move unintentionally. This affects 13 units distributed worldwide, primarily in Minnesota, Maryland, Pennsylvania, Canada, and numerous other countries.

Moderate·FDA·Jul 8, 2026

Boston Scientific is recalling 12 sizes of its CRE and CRE Pro Wireguided balloon catheters because the pouches they are packaged in may not keep the devices sterile. The recall covers 81,543 units per product and was distributed in the US and many other countries. No injuries have been reported.

Moderate·FDA·Jul 8, 202612 products

The IntelliCuff portable cuff pressure controller may display a "Cuff System Leakage" error and cause the motor to pump continuously instead of maintaining the pressure set by the user. This can prevent the device from working as intended.

Moderate·FDA·Jul 8, 2026·Hamilton Medical AG

Medacta's Short Monobloc Stem Broaches (sizes 7–16), used during shoulder replacement surgery, have a manufacturing issue that causes the surgical instruments to be positioned slightly off-center during the procedure. This misalignment may increase the risk of fractures in the upper arm bone.

Moderate·FDA·Jul 8, 2026·Medacta Usa Inc

DePuy (Ireland) is recalling 2 ATTUNE Revision Hinge knee components, a housing component and an insert component, because the outer sterile packaging was found stuck to the inner sterile packaging, which could compromise sterility. The recall covers 226 units distributed to Minnesota, North Carolina, and Texas. No injuries have been reported.

Moderate·FDA·Jul 8, 2026·DEPUY (IRELAND)2 products

A single lot of 10cc Luer Lok syringes (Lot 8298877) with an expiration date that had passed were distributed to hospitals and medical facilities in California, Florida, and Pennsylvania due to a failure in the distribution system's inventory controls. About 1,401 syringes were affected. No injuries have been reported.

Moderate·FDA·Jul 8, 2026·Mentor

Medline is recalling 8 convenience kits that contain Swan-Ganz catheters made by Becton Dickinson (BD). BD received complaints that the blue hub on these catheters can leak or break, which may lead to infection, medication loss, or blood loss. No injuries have been reported, and the kits were distributed in AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, and WI.

Moderate·FDA·Jul 8, 20268 products

Medline is recalling 15 convenience kits that contain Huons lidocaine ampules. Huons issued the recall after an FDA inspection of its manufacturing site found quality problems with the ampules. No injuries have been reported.

Moderate·FDA·Jul 8, 202615 products

Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain elevated levels of N-nitroso-cinacalcet, a manufacturing impurity that exceeds FDA safety limits. The affected bottles were distributed nationwide.

Moderate·FDA·Jul 8, 20263 products

Lannett Company distributed amphetamine extended-release capsules that contained only immediate-release pellets but were labeled as extended-release. This labeling error could result in incorrect dosing and medication timing for patients who depend on the extended-release formulation.

Moderate·FDA·Jul 8, 2026

Asclemed USA Inc. is recalling two lidocaine HCl 1% injection products in 5 mL single-dose ampules, sold nationwide. One is sold as Accucaine kits and the other is an unbranded lidocaine injection; both were distributed by Enovachem Pharmaceuticals. The recall was issued because the products may not be sterile, and no injuries have been reported.

Moderate·FDA·Jul 8, 2026·Asclemed USA Inc.2 products

Boehringer Ingelheim Pharmaceuticals is recalling one lot of Synjardy XR 12.5/1000 mg tablets due to manufacturing quality control issues. During production, an incorrect cleaning agent was used on equipment, and required testing of that equipment was not completed before the tablets were made.

Moderate·FDA·Jul 8, 2026·Boehringer Ingelheim

Accord Healthcare is recalling one lot of levothyroxine sodium 300 mcg tablets because they may contain less active ingredient than labeled. This means the medication may not work as intended for patients who need it to manage thyroid conditions.

Moderate·FDA·Jul 8, 2026·Accord Healthcare

Lupin Pharmaceuticals is recalling multiple lots of prednisolone acetate ophthalmic suspension 1% (an anti-inflammatory eye drop) due to the presence of a foreign substance in some bottles. The affected lots were distributed nationwide. No injuries have been reported.

Moderate·FDA·Jul 8, 2026

Accord BioPharma is recalling one lot of IMULDOSA (ustekinumab-srlf) injection due to lack of assurance that the product is sterile. The affected lot may not meet sterility standards required for injectable medications. No injuries have been reported.

Moderate·FDA·Jul 8, 2026·ACCORD BIOPHARMA INC

CareFusion is recalling 10 antiseptic skin prep products sold as BD ChloraPrep (Hi-Lite Orange, Clear and Scrub Teal), BD PurPrep, and ChloraPrep FREPP. Applicators that were meant to be sterilized before use were instead shipped to customers outside the intended distribution channel, so they may not be sterile. No injuries have been reported.

Moderate·FDA·Jul 8, 202610 products

Lupin Pharmaceuticals is recalling certain lots of its Glucagon Emergency Kit because the syringe plunger may not move smoothly during use. This defect was discovered during stability testing and could prevent the kit from working properly in an emergency.

Moderate·FDA·Jul 8, 2026

Kao USA recalled select lots of Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz) made between February 21–26, 2026 after detecting Pluralibacter gergoviae bacteria. People with weakened immune systems may be at higher risk of infection.

Moderate·FDA·Jul 1, 2026·Kao

Medline is recalling 16 convenience kits that contain 10mL polycarbonate colored syringes. The company found design changes to these kits that were not cleared by the FDA, and the products were not included in an earlier report. The kits were shipped nationwide and to Barbados, and no injuries have been reported.

Moderate·FDA·Jul 1, 202616 products

Boston Scientific has recalled one INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to the potential for leakage along the drug pathway from the pump through the catheter end. This is an implantable device used to deliver medication directly to the liver. The affected device was distributed in Ohio.

Moderate·FDA·Jul 1, 2026

Philips Telemetry Monitor 5500 (model 867232) devices may unexpectedly reset to a default state, causing them to lose their configuration settings and disconnect from the hospital's central monitoring system. This could prevent the monitor from reconnecting to the PIC iX central system until manually reconfigured.

Moderate·FDA·Jul 1, 2026

Zimmer discovered that 12 units of the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Size 9/9+, 10mm thickness) contained an incorrect posterior augment component in the package instead of the correct distal augment. No patient injuries have been reported.

Moderate·FDA·Jul 1, 2026

Medtronic recalled three models of its Octopus tissue stabilizers, covering 1,012 units in total. During manufacturing, the company found that the tubing was attached backwards, with the short tube on the bottom of the canister and the long tube on top. No injuries have been reported.

Moderate·FDA·Jul 1, 20263 products