FDA medical device recalls

CliniClean Pericare Wipes included in certain Cardinal Health surgical catheter trays may contain residual lubricant from manufacturing. If used on a patient, these wipes could cause localized skin irritation, redness, or mild inflammation.

Certain Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays may have wipes contaminated with a lubricant from manufacturing. If used on a patient, contaminated wipes could cause localized skin irritation, redness, or mild inflammation.

Cardinal Health BD Urinary Catheter Trays 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.

CliniClean Pericare Wipes included in certain BD urinary catheter trays may contain residual manufacturing lubricant. If used on a patient, the contaminated wipes could cause localized skin irritation, redness, or mild inflammation.

Certain surgical catheter trays sold by Cardinal Health 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.

CliniClean Pericare Wipes included in certain BD Urinary Catheter Trays may contain residual lubricant from manufacturing. If used on a patient, these wipes could cause localized skin irritation, redness, or mild inflammation.

BD Urinary Catheter Trays sold with CliniClean Pericare Wipes may contain wipes contaminated with lubricant from manufacturing. If used on a patient, the contaminated wipes could cause skin irritation, redness, or mild inflammation.

Certain surgical kits containing CliniClean Pericare Wipes in BD Urinary Catheter Trays may have residual manufacturing lubricant on the wipes. If used on a patient, the contaminated wipes could cause localized skin irritation, redness, or mild inflammation.

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.