Medical device recalls

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.

AVID Medical is recalling Halyard HEAD AND NECK TRAY (Catalog Number EURO016-09) due to a potential incomplete seal on the header bag. This affects 56 units distributed in Georgia, Illinois, Nebraska, and Maryland. An incomplete seal could compromise the sterility or integrity of the surgical tray.

AVID Medical is recalling Halyard Major Pack surgical kits (Catalog Number JEMJ10-01) because the header bag seal may not close completely. This affects 90 units distributed to Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.

AVID Medical is recalling Halyard arteriogram kits (Catalog Number EUHM009-01) because the header bag may not seal completely. This could allow the sterile contents inside to become contaminated. The recall affects 300 units distributed to hospitals in Georgia, Illinois, Nebraska, and Maryland.

AVID Medical is recalling Halyard EP LAB PK sterile field packs (Catalog Number ESJH009-03) because the header bag may not seal completely during sterilization. An incomplete seal could allow bacteria or other contaminants to enter the sterile package before use. This affects 240 units distributed to hospitals and medical facilities in Georgia, Illinois, Nebraska, and Maryland.

Halyard's General Laparoscopy Pack (catalog number VAST018-10) may have an incomplete seal on its header bag, which could compromise the sterility of the surgical instruments inside. This affects 42 units distributed to hospitals and surgical centers in Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.

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.

Stryker recalled certain Arise 1000EX mattresses because some were sold near MV3 beds, raising concern they might be used together. The mattress and bed have not been tested together and are not designed to work as a pair. Using them together is not recommended by Stryker.

Stryker recalled certain MV3 bariatric beds because some were sold near Arise 1000EX mattresses, suggesting they might be used together. The bed and mattress have not been tested for compatibility and should not be used together.

Datascope Corp. is updating the maintenance schedule for Cardiosave Rescue intra-aortic balloon pump systems to match changes made to the Service Manual in June 2023. This affects 47 units distributed worldwide. No injuries have been reported.

Datascope Corp. has updated the preventative maintenance schedule for Cardiosave Hybrid intra-aortic balloon pump systems to match changes made to the Service Manual in June 2023. Users should review the updated Instructions for Use (IFU) addendum to ensure proper maintenance timing.

A screw in certain Nipro Surdial DX hemodialysis systems may loosen or fall out during use. This is a medical device used in dialysis treatment. The affected units have specific serial numbers issued between 2020 and 2024.

Medline Industries is recalling DEXLOCK Achilles Repair Implant Kits (model MAKT4520, lot 19019) because the drill bit can fuse to the drill guide during surgery. This can delay the procedure while a replacement drill bit and guide are retrieved. No patient injuries have been reported.

A wire inside the AMSCO 7053HP Washer/Disinfector may shift out of position and cause electrical arcing within the unit. The arcing occurs inside the machine and does not pose a shock risk to users. This affects 22 units with specific serial numbers distributed in the US and Australia.

A wire in the electrical box of the AMSCO 7052HP Washer/Disinfector may shift out of position, causing electrical arcing inside the unit. The arcing occurs internally and does not pose a shock risk to users, but could affect equipment function or safety.

C.R. Bard Inc. has recalled certain BD InLay Optima Ureteral Stent Kits (8 Fr. x 26 cm, REF 78826, Lot# NGJU4328) because the actual stent size may not match what the label says. This labeling error could lead to incorrect stent selection during medical procedures.

C.R. Bard Inc. is recalling a specific lot of BD InLay Optima Ureteral Stent Kits (6 Fr. x 30 cm, Ref 788630, Lot NGJU4327) because the actual stent size may not match what is printed on the product label. This discrepancy could affect proper stent selection and placement.

BD InLay Optima Ureteral Stent Kits (4.7 Fr. x 26 cm, Lot NGJU4181) have a labeling error—the printed size on the package may not match the actual stent inside. This affects 4,350 units distributed across multiple U.S. states and internationally. No injuries have been reported.

C.R. Bard Inc. is recalling certain InLay Optima ureteral stent kits (6 Fr. x 14 cm, REF 787614, Lot# NGJU4163) because the actual size of the stent may not match what is printed on the package label. This discrepancy could affect proper medical placement and treatment.

Medline has found that Quick Strip Fabric Sterile Adhesive Bandages (1" x 3") may have open or damaged seals on their packaging. When the seal is compromised, the sterility of the bandages inside cannot be guaranteed. This affects all lots of the product.

Medline Industries has recalled all lots of Quick Strip Fabric Sterile Adhesive Bandages (0.75" x 3", Item Number NON25650QS) because the packaging seals may be open, which could allow bacteria or other contaminants to reach the bandages and compromise their sterility. No injuries have been reported.

Medline discovered that Fur Friends Plastic Sterile Adhesive Bandages (0.75" x 3") may have open or damaged seals in their packaging. This damage could allow bacteria or other contaminants to reach the bandages, making them non-sterile even though they are labeled as sterile. The issue affects all lots of the product.