FDA medical device recalls

RayCare 2024A SP4 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 are not alerted when these changes occur, which could affect treatment record accuracy.

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.

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.

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.

The Siemens ARTIS icono floor medical imaging system may lose movement capability when the detector lift height is adjusted to its maximum or minimum position. This affects 30 units with specific serial numbers distributed nationwide.

Siemens Medical Solutions USA is recalling the ARTIS icono ceiling model 11328100 due to a potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits. This affects 119 units distributed nationwide.

Siemens Medical Solutions USA is recalling certain ARTIS icono biplane X-ray systems (Model 11327600) because the detector lift height may stop moving when adjusted to its maximum or minimum limits. This could prevent the equipment from operating normally during medical imaging procedures.

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.

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.

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.

Boston Scientific has recalled certain CRE Wireguided catheters (18–20 mm, 240 cm) because the sterile pouches containing these devices may have been breached during manufacturing or packaging. A breach could allow bacteria or other contaminants to enter the device before use. No injuries have been reported to date.

Boston Scientific Corporation is recalling CRE Wireguided 15-18mm 240cm catheters due to a potential sterile breach in the packaging pouches. The affected devices were distributed worldwide and may not maintain sterility if the pouch integrity is compromised. No injuries have been reported.

Boston Scientific has recalled certain CRE Wireguided 12-15mm catheters (model M00558480) due to a potential sterile breach in the device packaging pouches. The affected devices were distributed worldwide, including in the United States. No injuries have been reported.

Boston Scientific has recalled certain CRE Wireguided catheters (10-12mm, 240cm) due to a potential breach in the sterile packaging pouches. The affected devices were distributed worldwide. No injuries have been reported.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Boston Scientific Corporation is recalling certain CRE Pro Wireguided catheters (18–20 mm, 240 cm) due to a potential sterile breach in the packaging pouches. The breach could compromise the sterility of the devices before use. This affects approximately 81,543 units distributed worldwide.

Boston Scientific has recalled CRE Pro Wireguided catheters (15–18mm, 240cm) because some packaging pouches may have a sterile breach. This affects specific lot numbers distributed worldwide. No injuries have been reported.

Boston Scientific recalled certain CRE Pro Wireguided catheters (12–15 mm, 240 cm) due to a potential breach of the sterile packaging pouches. Affected units were distributed worldwide and have expiration dates between November 2028 and March 2029. The company has not reported any injuries related to this issue.

Boston Scientific Corporation is recalling CRE Pro Wireguided catheters (10–12 mm, 240 cm) because the sterile packaging pouches may have been compromised. This affects over 81,000 units distributed worldwide. The breach could allow contamination of the device before use.

Boston Scientific has recalled certain CRE Pro Wireguided catheters (8–10 mm, 240 cm) because the sterile pouches protecting these devices may have been breached during manufacturing or packaging. A breached sterile barrier could allow bacteria or other contamination to reach the device before use. The recall affects 81,543 units distributed worldwide.

Boston Scientific identified a potential sterile breach in the packaging of certain CRE Pro Wireguided 6-8mm 240cm catheters. The devices may have been exposed to contamination during packaging. No injuries have been reported.

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.

Certain lots of the Medtronic Harmony Delivery Catheter System may have a manufacturing defect that increases the risk of the distal tip detaching from the delivery system during use. This could occur under specific procedural or anatomical conditions. About 1,881 units worldwide are affected.

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Windstone Medical's AMS Preop Kit-NS surgical convenience kits contain Webcol Large Alcohol Prep Pads that were recalled due to bacterial contamination (Paenibacillus phoenicis) discovered during sterilization testing. The contamination was identified by Cardinal Health, the pad manufacturer. About 200 kits with specific lot codes are affected.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

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.