New York recalls

ICU Medical's IV tubing sets with drip chambers may contain black specks caused by discolored plastic material from the manufacturing process. Particles or discoloration in the fluid path have not been ruled out.

ICU Medical oncology IV tubing sets may contain small black specks in the drip chamber. These specks are discolored plastic from the manufacturing process and do not enter the fluid path. Healthcare providers who notice them may replace the tubing set before use, which could delay patient treatment.

ICU Medical oncology IV tubing sets may contain small black specks in the drip chamber. These specks are discolored plastic material from the manufacturing process and do not enter the fluid path. Healthcare providers who notice the specks may replace the set before use, which could delay treatment.

Some ICU Medical IV gravity administration sets contain black specks in the drip chamber wall caused by the plastic molding process. The specks do not enter the fluid path but may prompt healthcare providers to replace the tubing before use, potentially delaying patient therapy.

ICU Medical's Plum intravascular administration tubing sets may contain black specks in the drip chamber. The specks appear to be discolored PVC material from the manufacturing process. Particulate matter could potentially enter the fluid path.

A component in the purge pressure sensor assembly of certain Abiomed Impella Optical Controller and Impella Connect devices may fail, preventing proper recognition of the purge cassette. This affects approximately 4,100 devices distributed globally. No injuries have been reported to date.

A component in the purge pressure sensor assembly of certain Abiomed Impella Optical Controllers may fail, preventing the device from properly recognizing the purge cassette. This could affect the device's operation during cardiac support procedures. The issue affects 1,422 units distributed in the US and internationally.

A component in the purge pressure sensor assembly of certain Abiomed Impella Controllers may fail, preventing the device from properly recognizing the purge cassette. This could affect the device's ability to function correctly during use.

Bayer Medical Care has recalled MEDRAD Stellant FLEX Syringe Kits (catalog number FLEXS-150-QFT) used with the Stellant FLEX CT Injection System because some devices may not have been properly sterilized during manufacturing. The recall affects approximately 27,800 kits across the United States.

Maquet Cardiopulmonary's Percutaneous Insertion Kit (PIK) dilator set L may have packaging that does not reliably maintain sterile barrier integrity. This affects specific lot numbers distributed worldwide. No injuries have been reported.

Maquet Cardiopulmonary has recalled specific lots of its Percutaneous Insertion Kit (PIK) Guidewire 150 cm because the packaging may not reliably maintain sterile barrier integrity. This could allow contamination of the sterile device. The company identified the issue and is recalling affected units.

Maquet Cardiopulmonary identified that packaging on certain lots of their Percutaneous Insertion Kit (PIK) Guidewire 100 cm may not reliably maintain sterile barrier integrity. This medical device is used in cardiopulmonary procedures. The issue affects approximately 1,765 units in the U.S. and 66,606 units internationally across multiple countries.

GE's Carescape Central Station patient monitoring system may take up to 3 minutes to resume monitoring after a restart. During this gap, clinically important changes in a patient's condition might not be detected right away.

A software malfunction in certain versions of the Philips PIC iX Essentials patient information system can cause the system to freeze and become unresponsive. The affected software versions are 4.0 through 4.5. No injuries have been reported.

A software malfunction in Philips Patient Information Center iX (versions 4.0–4.5) can cause the patient information system to freeze and stop responding. This affects healthcare facilities using the affected software versions worldwide.

Medline's Open Heart Convenience Kit (DYNJ43008N) contains a coronary cannula with a potential sterile barrier breach. If a compromised pouch seal isn't caught before use, the non-sterile device could cause infection or serious complications including blood cell breakdown, blood clots, or organ damage.

A software issue in the StatStrip Glucose and B-Ketone meter (Model 66429) can cause the device to display a patient's barcode from a previous test when scanning a new patient's barcode. If an operator doesn't notice the mismatch and accepts the wrong information, one patient's glucose result gets recorded in another patient's medical record, leaving the current patient without a result and potentially leading to incorrect treatment decisions.

A software bug in the StatStrip Glucose and B-Ketone meter (Model 63910) can cause the device to display a previously scanned patient barcode when scanning a new one. If an operator doesn't notice the mismatch and accepts the incorrect patient information, the current patient's glucose result gets recorded in the wrong patient's medical record, and the actual patient receives no result. This could lead to incorrect treatment decisions, especially for critically ill patients, newborns, and infants.

A software timing issue in the StatStrip Glucose and B-Ketone meter (Model 63683) can cause the device to display a previously scanned patient barcode when scanning a new patient's barcode. If the operator doesn't notice the mismatch, the current patient's glucose result gets recorded under the wrong patient's medical record, and the actual patient's result is never recorded. This could lead to incorrect treatment decisions, particularly for critically ill patients, newborns, and infants.

The StatStrip Glucose Hospital Meter has a software glitch that occasionally causes it to display an old barcode on the screen after scanning a new one. If a healthcare worker doesn't notice the mismatch and approves the test, the glucose result gets recorded in the wrong patient's medical record. This could lead to incorrect treatment decisions, especially for critically ill patients, newborns, and infants.

A software timing issue in the StatStrip Glucose Hospital Meter (Model 63685) can cause the device to display a previously scanned patient barcode when a new barcode is scanned. If a clinician accepts the wrong patient information without noticing, the current patient's glucose result gets recorded in the previous patient's medical record, and the current patient receives no result. This can lead to incorrect treatment decisions, especially in critically ill patients and infants.

Certain lots of sterile applicators in Medline Convenience Kits may contain a fungus called Aspergillus penicillioides. This fungus can grow under certain storage conditions and could cause serious infections if the contaminated applicators are used on skin.

Certain lots of sterile applicators in Medline Convenience Kits may be contaminated with Aspergillus penicillioides fungus. This fungus can grow under certain environmental conditions and may cause serious infections, including sepsis, if the contaminated applicators contact skin during preparation.

Certain lots of sterile applicators in Medline Convenience Kits may contain fungal contamination (Aspergillus penicillioides) that could grow under certain environmental conditions. This contamination can cause serious infections including sepsis.

Several lots of Medline Convenience Kits contain sterile applicators that may be contaminated with Aspergillus penicillioides, a fungus that can grow under certain conditions. If these kits are used on skin, the contamination could cause serious infection, including sepsis.

Medline Convenience Kits contain sterile applicators that may be contaminated with Aspergillus penicillioides fungus. This contamination could occur during manufacturing under certain environmental conditions. If these kits are used on skin, the fungal contamination could potentially lead to serious infections.

Medline's Open Heart Adult, Full Line Aneurysm, and Non Sterile Chest Tube Removal convenience kits contain certain lots of sterile applicators that may be contaminated with Aspergillus penicillioides fungus. This fungus can grow under certain conditions and may cause serious infections including sepsis.

Certain lots of sterile applicators in Medline's Anesthesia L&D A-Line Set kits may contain Aspergillus penicillioides fungal contamination. This fungus can grow under certain environmental conditions and contaminate skin preparation products, potentially causing serious infections including sepsis.

Halyard IV START KIT convenience kits (Lot 1658437) contain applicators contaminated with Aspergillus penicillioides, a fungus. The contamination was found in BD ChloraPrep Clear and FREPP Clear applicators included in the kits. This is a Class I recall affecting 288 units distributed in Nebraska.

BD Switzerland has recalled multiple models of Alaris Pump Infusion Sets due to discrepancies in performance data attributes. These discrepancies may cause the infusion pump to operate inappropriately. No injuries have been reported.