Texas recalls

The instruction manual and labeling for the Rocket 18Fg Seldinger Catheter Procedure Tray contain misleading information that may cause the chest tube to be secured incorrectly. This could result in the tube falling out during use.

Rocket Medical's 12Fg Seldinger Catheter chest tubes have misleading instructions that may lead to improper securing of the device. This increases the risk that the catheter could fall out during use. The FDA has identified 240 units across multiple lot codes distributed in the US and internationally.

IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.

DSAART LLC distributed calf implants that did not meet FDA requirements. The products were sold without required FDA premarket approval or clearance, and some deviated from manufacturing specifications. Approximately 35 implants were distributed across multiple U.S. states.

DSAART LLC distributed AART Pectoral Implants that were manufactured differently than approved and were sold without required FDA clearance. The implants do not meet established safety and quality standards. Affected models were distributed across multiple U.S. states.

DSAART LLC distributed AART Malar Implants (model 401-202-5 and 401-202-6, lot numbers 24-01-014 and 24-01-015) without obtaining required FDA premarket approval and with deviations from established manufacturing specifications. Two implants were affected and distributed across multiple U.S. states.

DSAART LLC distributed AART Chin Implants that were manufactured with deviations from established specifications and without obtaining required FDA premarket approvals or clearances. The affected implants were distributed across multiple U.S. states.

DSAART LLC distributed gluteal implants without FDA approval and in ways that deviated from approved specifications. The FDA has recalled 118 implants across multiple models and lot numbers distributed in 28 U.S. states and territories. No injuries have been reported.

DSAART LLC distributed AART Silicone Carving Implants without obtaining required FDA premarket approval or clearance, and some products deviated from established manufacturing specifications. These implants are used in augmentation and reconstructive surgery. The FDA has issued a Class II recall affecting 369 implants distributed across multiple U.S. states.

Copan Italia's DTT (dithiothreitol) liquid reagent, used to prepare respiratory specimens in laboratories, may not work properly. The reagent is supplied in 1ml PET tubes with capture caps. There have been no reported injuries, but the functionality cannot be guaranteed for specimen fluidification.

Copan Italia's DTT (dithiothreitol) reagent tubes used with the WASP microbiology system may not reliably liquefy respiratory specimens as intended. This could affect the quality of lab test results. The issue affects approximately 122,850 units distributed across multiple US states.

Intelerad InteleShare medical imaging software versions 3.24.3 through 3.25.2 contain a bug that can produce inaccurate measurement values when certain viewing features are used together. This could lead to incorrect measurements on medical images, potentially affecting diagnosis and treatment planning.

The instruction guide for SeaSpine's NorthStar OCT Navigation surgical instruments incorrectly states that the tools work with both Medtronic Solera and Infinity system toolcards. In fact, they only work with Solera toolcards. Using these instruments with an Infinity system toolcard could result in device malfunction during surgery.

GE HealthCare ViewPoint 6 versions 6.15.3 and 6.15.4 may not display complete patient medical history information in the Patient History tab. This affects specific ultrasound systems used in medical facilities. No injuries have been reported.

Datascope Corp. has issued an updated instruction manual (IFU) for the Cardiosave Rescue defibrillator. The update corrects references in the Vibration and Shock Table to match the proper technical standards. This affects 47 units distributed in the US and internationally.

Datascope Corp. is updating the instruction manual for Cardiosave Hybrid devices to correct references in the Vibration and Shock Table to ensure alignment with applicable standards. This is a documentation correction that affects multiple device models.

Zimmer Surgical Inc. is recalling certain Dermatome AN surgical devices (Model 88710100) because the thickness control bar may be misaligned. This could affect the device's ability to cut skin grafts to the correct thickness during surgery. No injuries have been reported.

Zimmer Surgical Inc. is recalling certain Zimmer Air Dermatome surgical devices because the thickness control bar may be misaligned. This could affect how the device operates during skin grafting procedures. No injuries have been reported so far.

Medline Industries' sterile Kelly forceps (5.5 inch, Item DYNJ04048) may have packaging seals that don't hold properly. If the seal fails, the sterile barrier is broken, which could allow bacteria or other germs to contaminate the instrument and increase infection risk if used.

Medline Industries sterile surgical scissors (5.5", Item DYND04000, Lot 2023102590) may have weak packaging seals that could break during storage or handling. If the sterile packaging fails, the scissors could become contaminated and increase infection risk if used in surgery or medical procedures.

Mindray's BeneVision Distributed Monitoring System (DMS) workstations with specific hardware and audio driver configurations may experience audio playback failure or screen freezing during operation. This can affect the usability of the central monitoring system in clinical settings. About 906 units are affected worldwide.

GE Healthcare has recalled certain Power Management Boards in Carestation 600 and 700 Series anesthesia systems. If AC power is lost or unplugged, these systems may unexpectedly shut down instead of switching to battery backup, causing temporary disruption of ventilation and medication delivery. After restart, the system will not return to its previous settings.

GE Healthcare has recalled certain Carestation 750 anesthesia systems that may unexpectedly shut down if AC power is lost or unplugged. When this happens, the system will not automatically switch to battery backup and will reboot, which can temporarily disrupt ventilation and medication delivery. After rebooting, the system does not return to its previous settings.

GE Healthcare's Carestation anesthesia systems (600 and 700 Series) may unexpectedly shut down if AC power is lost or unplugged. When this happens, the system does not automatically switch to battery backup and will restart instead. During the restart, ventilation and anesthetic gas delivery may briefly stop, and the system will not return to previous ventilation settings after reboot.

Fresenius Kabi has recalled software version 5.10.1 and earlier for the Ivenix Infusion System due to anomalies that could cause serious patient harm. The affected software is used to control the delivery of fluids to patients in medical settings. About 30 units have been distributed across multiple U.S. states.

Belevini BICHKI dried salted whole smelts may contain Clostridium botulinum, a bacteria that causes a serious illness called botulism. The fish was not properly cleaned before drying and salting, which allowed the bacteria to grow. This product was distributed to New York, Texas, Pennsylvania, New Jersey, and Florida.

Belevini KORUSHKA dried salted smelts may contain Clostridium botulinum, a dangerous bacteria that causes botulism, a serious paralytic illness. The fish were not properly cleaned before processing, which allowed the bacteria to grow. The affected product was distributed to New York, Texas, Pennsylvania, New Jersey, and Florida.

Taro Pharmaceuticals is recalling specific lots of Ciclopirox Shampoo 1% because the product failed quality tests for impurities and degradation at the 18-month mark. The affected lots expire January 31, 2026. No injuries have been reported.

Preferred Pharmaceuticals is recalling ondansetron ODT 4mg tablets because the blister pack containers are not fully sealed, which can cause tablets to fall out. The manufacturer Glenmark Pharmaceuticals notified Preferred Pharmaceuticals of the sealing defect. This affects specific lot numbers distributed nationwide.

Somerset Therapeutics is recalling cisatracurium besylate injection (a muscle relaxant used during surgery) because stability testing found the drug strength fell below the required standard. Lot A250043 with expiration date 06/30/2026 is affected. The company has not reported any injuries.