Pennsylvania recalls

BD Urinary Catheter Trays in Cardinal Health Presource Packs contain CliniClean Pericare Wipes that may be contaminated with lubricant from manufacturing. If used on a patient, the contaminated wipes could cause localized skin irritation, redness, or mild inflammation.

Fresenius Medical Care has recalled specific lots of Citrasate Liquid Acid Concentrate used in hemodialysis due to blue-green discoloration observed in the product. The discoloration may indicate a quality issue that could affect the product's safety or efficacy. No injuries have been reported.

Fresenius Medical Care is recalling specific lots of NaturaLyte Liquid Acid Concentrate used in bicarbonate hemodialysis due to reports of blue-green discoloration in the product. The affected lots were distributed nationwide in the U.S. and in Mexico.

Fresenius Medical Care has recalled certain lots of GRANUFLO Dry Acid Concentrate used in hemodialysis machines after receiving reports of blue-green discoloration in the product. The affected product numbers are 0FD2251-3B and 0FD3251-3B, with specific lot numbers listed by the FDA.

Specific lots of B Braun's Discofix Four Way Stopcock extension sets have an incorrect expiration date printed on the carton shipper label. This labeling error could affect proper product tracking and usage verification.

A software issue in the robotic controller of the Medos Velys Enabling Tech Robotic-Assist Station may cause the robotic arm to move unexpectedly during bone preparation or instrument positioning in orthopedic surgery. This affects 29 devices nationwide.

Fresenius Medical Care is recalling specific lots of the 5008X HD/HDF Twister Blood Tubing Set (Part Number 03-5350-8) because the connection between the Arterial Alpha Clip and the main line may leak during dialysis treatment. A leak could result in blood loss and low blood volume.

Fresenius Medical Care is recalling certain 5008X HD/HDF blood tubing sets (part number 03-5300-3C) due to a heightened risk of blood leaks at the connection between the Arterial Alpha Clip and the main line. Blood leaks during dialysis treatment can result in significant blood loss.

Fresenius Medical Care is recalling certain 5008X HD/HDF Standard Blood Tubing Sets due to a heightened risk of blood leaking from the connection between the Arterial Alpha Clip and the main line or pump segment. A blood leak during dialysis treatment could result in blood loss and low blood volume.

Fresenius Medical Care is recalling certain 5008X Standard HD Pre-Flush blood tubing sets due to a heightened risk of blood leaking from the connection between the Arterial Alpha Clip and the main line. A leak during dialysis treatment could result in blood loss.

Boston Scientific's server software for LUX-Dx insertable cardiac monitors may delay notifications of atrial fibrillation (AF) burden alerts. This delay could postpone a doctor's evaluation or treatment of an irregular heart rhythm.

Boston Scientific's LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors may experience delays in sending AF Burden Alert notifications through their server software. These delayed alerts could postpone a patient's medical evaluation or treatment for irregular heart rhythms.

Boston Scientific's server software that supports LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors may delay notifications of abnormal heart rhythm (atrial fibrillation) alerts. This delay could postpone a patient's clinical evaluation or treatment of an irregular heartbeat.

Medline Industries is recalling specific lots of Convenience Kits that contain BD ChloraPrep Clear applicators because some applicators may have open or incomplete seals on their packaging. If a contaminated applicator is used during a medical procedure, it could cause a skin, soft tissue, or systemic infection.

Medline Convenience Kits containing BD ChloraPrep Clear applicators may have open or incomplete seals on the applicator packaging. If used, a potentially contaminated applicator could cause a skin, soft tissue, or systemic infection.

Medline Convenience Kits containing BD ChloraPrep Clear 1mL applicators may have packaging with open or incomplete seals. This can allow contamination of the applicator, which is used to prepare skin before surgery. If a contaminated applicator is used, it could cause skin or soft tissue infection.

Medline Industries recalled specific lots of Convenience Kits that contain BD ChloraPrep Clear skin antiseptic applicators. Some applicators may have open or incomplete seals on their packaging, which could allow contamination. Using a compromised applicator could lead to skin, soft tissue, or systemic infection.

Medline Convenience Kits containing certain lots of BD ChloraPrep Clear applicators may have packaging seals that are open or incomplete. These applicators could be contaminated and may cause skin infections or more serious infections if used.

BD ChloraPrep Clear applicators in certain Medline pre-op convenience kits may have open or incomplete seals on their packaging. If a sealed applicator is compromised, it could become contaminated and cause a skin, soft tissue, or systemic infection when used.

Medline Convenience Kits containing BD ChloraPrep Clear applicators are being recalled because some applicator packages may have broken or incomplete seals. If the applicator is contaminated, it could cause skin, soft tissue, or systemic infections when used for blood draws.

Medline Industries is recalling specific lots of Convenience Kits that contain BD ChloraPrep Clear 1mL applicators due to a manufacturer recall of those applicators. Some applicators may have open or incomplete seals on their packaging, which could allow contamination. Using a contaminated applicator could lead to skin, soft tissue, or systemic infections.

Medline Convenience Kits containing BD ChloraPrep Clear applicators may have open or incomplete seals on the applicator packaging. Specific lots across four kit models (CDS860014Q, DYKM1000B, CDS860014P, DYNDV2684) are affected. If a compromised applicator is used, it could introduce contamination and lead to skin, soft tissue, or systemic infection.

Medline Industries is recalling multiple Convenience Kits because they contain BD ChloraPrep Clear applicators from affected lots. Some of these applicators may have open or incomplete seals, allowing contamination. Using a contaminated applicator during medical procedures could cause skin, soft tissue, or systemic infections.

Medline Industries is recalling specific lots of Convenience Kits that contain BD ChloraPrep Clear applicators. The applicator packaging may have an open or incomplete seal, which could allow contamination. If a contaminated applicator is used, it may cause skin, soft tissue, or systemic infection.

Medline is recalling Convenience Kits containing BD ChloraPrep Clear 1mL applicators because some units may have an open or incomplete seal on the applicator packaging. This defect could allow contamination, potentially leading to skin, soft tissue, or systemic infection if the applicator is used.

Medline Convenience Kits containing BD ChloraPrep Clear skin-prep applicators are being recalled because some applicator packages may have open or incomplete seals. If the seal is compromised, the applicator could become contaminated and cause a skin, soft tissue, or systemic infection when used before surgery or procedures.

A software issue in the Baxter Novum IQ Syringe Pump (Model 40800BAXUSL) may occur when you replace an empty syringe during a multi-syringe infusion while medication still needs to be delivered. This could affect the accuracy of drug delivery. Four loaner units have been identified and are affected.

A software problem in the Baxter Novum IQ Syringe Pump (Model 40800BAXUS) can occur when a syringe empties and is replaced during a multi-syringe infusion, potentially affecting the accuracy of medication delivery. The issue affects about 14,601 units distributed nationwide.

Johnson & Johnson is sending updated surgical instructions for HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products used in cataract surgery. The new instructions emphasize that if resistance is felt when inserting the cannula, surgeons should stop, withdraw the cannula, and reassess insertion conditions rather than forcing it—to avoid potential injury to the cornea, iris, or Descemet's membrane (a delicate eye structure).

Medline's blood draw and phlebotomy kits contain antiseptic applicators (BD ChloraPrep Clear and FREPP Clear) with wrinkles in the paper packaging that may compromise the sterile barrier. If the packaging is damaged, the applicators could be exposed to bacterial or microbial contamination before use.