Montana recalls

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.

Medline Industries has recalled all lots of Quick Strip plastic sterile adhesive bandages (1" x 3") because some packages may have open seals that could allow bacteria or contamination inside. This affects over 4 million units distributed in the US, Guam, Canada, and the UAE. No injuries have been reported.

Medline Industries identified that Quick Strip Plastic Sterile Adhesive Bandages (0.75" x 3") in all lots may have packaging seals that did not close properly. This means the bandages may not be sterile and could be contaminated. No injuries have been reported.

Medline discovered that some packages of Curad Quick Strip Fabric Bandages (item CUR1930P, 3/4" x 3") may have unsealed packaging, which could allow bacteria or contaminants to enter and compromise the sterility of the bandages. The issue affects all lots of these bandages.

Medline discovered that bandage packages may have open seals, which can allow bacteria and germs to contaminate the sterile bandages inside. This affects all lots of CURAD Touch-Free and Quick-Strip Bandages in the 0.75" x 3" size. No injuries have been reported so far.

Cardinal Health ChemoPlus protective gowns and sleeves have been mislabeled with a five-year shelf life when the actual shelf life is three years. The affected gowns may be used past their true expiration date if the incorrect label is relied upon. No injuries have been reported.

Orthofix has recalled certain CONSTRUX Mini Ti Spacer System units used in spine surgery because the product labeling contains claims that are not consistently present across all units. This is a labeling discrepancy issue with no reported injuries.

Orthofix U.S. LLC is recalling multiple models of the Forza Ti Spacer System because the product labeling contains claims that are not consistently present across all units. This is a labeling issue that may affect product identification and use.

Orthofix U.S. LLC is recalling FIREBIRD SI Fusion System screws (multiple sizes, catalog numbers 18-1025SP through 18-2070SP) because the product labeling contains claims that are not consistently present across all units. The issue affects 19,431 screws distributed nationwide and internationally.

Orthofix U.S. LLC is recalling multiple models of the Pillar SA PTC Spacer System because the product labeling contains claims that are not consistently present across all units. This is a labeling issue affecting the information provided with the device.

Orthofix U.S. LLC is recalling FORZA PTC Spacer System devices because the product labeling contains claims that are not consistently present across all units. This is a labeling issue, not a defect in the device itself.

Orthofix U.S. LLC is recalling multiple models of the CONSTRUX Mini PTC Spacer System because the product labeling contains claims that are not consistently presented across all units. This is a labeling issue only; no injuries have been reported.

Certain lots of Beckman Coulter Access 2 Reaction Vessels contain small defects on the bottom that may cause errors in laboratory immunoassay instruments. These defects could delay patient test results. The recall affects specific lot numbers distributed nationwide and globally.

Bard Peripheral Vascular Inc. is recalling Safe-T-Centesis 6 Fr Catheter Drainage Trays because the safety indicator on the catheter may show the wrong position—displaying "sharp" when the catheter is actually "blunt." This could lead medical staff to believe the catheter hasn't entered the body cavity when it actually has, potentially causing discomfort, treatment delays, or injury to organs or blood vessels.

Medline is recalling specific batches of Medline Perfusion Syringes (model DYNJ39223C) that contain BD Luer Tip Caps. BD's testing found that certain tip cap trays failed biocompatibility tests, meaning the plastic may cause skin irritation, allergic reactions, or other adverse effects if it contacts patients during use. No injuries have been reported so far.

Some GE Senographe Pristina, Pristina Serena, and Pristina Serena 3D mammography systems were distributed with a missing or incorrect X-ray warning label. This label is required by federal regulation to inform users of radiation hazards. No injuries have been reported.

Between July 2024 and June 2025, some Philips Azurion R3.0 fluoroscopic X-ray systems (model 722234) were shipped without a required safety spacer. This spacer ensures the X-ray tube maintains a safe distance from patients during standard fluoroscopy procedures, as required by FDA regulations.

Draeger's ErgoStar CM 45 airway connectors (Model MP01845) have developed cracks in the hose in certain units. These connectors are used to deliver breathing gases to patients on mechanical ventilators. The cracks could disrupt proper airflow during critical respiratory support.

Deep-brand Indian Kitchen Quick Cubes (Garlic of India) tested positive for Salmonella, a bacteria that can cause serious illness. The affected product is frozen and sold in 10 oz. bags. No illnesses have been reported yet.