South Carolina recalls

Bard Access Systems is recalling PowerMidline Catheters because the lidocaine ampoules (small vials) included with these catheters were manufactured under deficient manufacturing practices. The affected catheters are used for short-term intravenous access and blood sampling.

Bard Access Systems is recalling certain Power-Trialysis Slim-Cath short-term dialysis catheters because the lidocaine ampoules included with them were manufactured under deficient practices. The affected catheters are used to provide temporary vascular access for dialysis and related treatments.

Bard Access Systems is recalling multiple lots of Power-Trialysis short-term dialysis catheters because the lidocaine ampoules included with them were manufactured under deficient manufacturing practices. The affected catheters come in straight, curved extension, and Alphacurve styles with model numbers 5605150, 5605240, 5605300, 5615120, 5615200, and 5655120.

Bard Access Systems is recalling PowerPICC SV catheters (both 3 Fr and 4 Fr models) because the lidocaine ampoules included with these catheters were manufactured under deficient practices. These catheters are used for central venous access during intravenous therapy and blood sampling.

Bard Access Systems is recalling PowerPICC SOLO HF Catheters (5 Fr Triple-Lumen) because the lidocaine ampoules included with the kit were manufactured under deficient manufacturing practices. The affected lot (REKT1554) was distributed nationwide and internationally.

The lidocaine ampoules included with Bard's DuoGlide Short-Term Dialysis Catheters were manufactured under deficient practices and are being recalled by the supplier. The affected catheters are used for temporary vascular access during hemodialysis and related therapies.

Bard Access Systems is recalling Poly Midline Catheter kits (models CK000495A and CK000566) because the lidocaine ampoules included with them were manufactured under deficient practices. These catheters are used for short- or long-term peripheral venous access in hospitals and clinical settings.

Bard Access Systems is recalling three models of thoracentesis and paracentesis drainage trays because the lidocaine ampoules included in these kits were manufactured under deficient manufacturing practices. The affected trays are used to remove fluid from the chest or abdominal cavity during medical procedures.

The Shiley Disposable Decannulation Plug (DDCP), a red connector used on tracheostomy tubes to block airflow, carries labeling that incorrectly indicates it does not contain DEHP (a chemical compound). The product actually contains 30–35% DEHP. Users relying on the label may not be aware of DEHP exposure during use.

Certain Zeiss Intrabeam Spherical Applicator 1.5 cm units used in intraoperative radiation therapy did not meet manufacturing specifications. A total of 13 units were affected across the United States, Puerto Rico, and several other countries. No injuries have been reported.

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.

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.

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.