Medline recalls

Medline is recalling 13 surgical drape and medical convenience kit products because the adhesive can be difficult to remove from patients and may leave residue on the skin. No injuries have been reported. The recall covers US nationwide distribution and several other countries.

Moderate·FDA·Oct 22, 202613 products

Medline Industries recalled a foot-ankle convenience kit (SKU DYNJ65395A) because one component in the kit has an incorrect or discrepant shelf-life label. The issue affects 30 kits distributed in New York. No injuries have been reported.

Moderate·FDA·Oct 21, 2026

Medline is recalling six convenience kits that contain CONMED AirSeal Access Ports, with 3,551 kits affected for each product listed. The ports may give false overpressure alerts and vent during use, which could delay or end a procedure. The kits were distributed nationwide, including AZ, CA, IN, MD, MO, NJ, OH, and WI, and no injuries have been reported.

Moderate·FDA·Oct 21, 20266 products

Medline is recalling 12 groups of surgical convenience kits, including cardiac, vascular, spinal, neuro, and ear kits. Some kits contain cannula components that do not meet ISO 80369-7 size requirements, which may cause leaking or breaking during use. No injuries have been reported.

Moderate·FDA·Oct 21, 202612 products

Medline is recalling two bariatric basic steel rollator walkers, 2,659 units in total. The front wheel assembly can disconnect from the frame, causing the front wheels to become loose or detach during use, which could lead to falls and serious injuries such as head trauma or fractures. No injuries have been reported, and the products were distributed nationwide in the US and to Canada.

Serious·FDA·Oct 14, 20262 products

Medline is recalling two products: hand control pendants and their wiring used with certain home care beds. The pendant or its wiring can overheat, which may cause smoking, sparking, melting, burning, or fire. About 771,127 units are affected, and the recall was expanded on 11/26/2025 to add products.

Serious·FDA·Oct 7, 20262 products

Medline is recalling three convenience kits, 1,057 kits in total, because their neurological sponges may contain endotoxin levels that vary unpredictably. Elevated endotoxin can cause reactions such as fever, local inflammation, low blood pressure, or nausea, and may need medical care. No injuries have been reported.

Moderate·FDA·Sep 30, 20263 products

Medline convenience kits (models DYNJ48258D and DYNJ48258F) contain Healthmark Instrument Channel Brushes with a potential sharp edge or burr on the brush end. This sharp edge could cause a cut, abrasion, or infection if the brush is handled or used.

Moderate·FDA·Sep 30, 20262 products

Medline is recalling four convenience kit products because some kits may have open seals in their sterile pouch packaging. An open seal may compromise sterility, which could lead to contamination of a sterile field or patient infection if the kit is used. The recall covers 1,196 affected units distributed nationwide, with distribution listed in Arkansas, Florida, North Carolina, Maryland, and Texas.

Moderate·FDA·Sep 23, 20264 products

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.

Serious·FDA·Sep 23, 2026

Medline is recalling seven groups of convenience kits because certain lots of sterile applicators may contain fungus (Aspergillus penicillioides). Skin preparation products contaminated with this fungus can cause serious infections, including sepsis, and death. The kits were distributed nationwide, and the FDA has classified this as a Class I recall, its most serious category.

Serious·FDA·Sep 23, 20267 products

Medline is recalling 13 convenience kits that contain BD ChloraPrep Clear 1mL applicators from specific lots. The applicator packaging may have an open or incomplete seal, so the applicator could be contaminated. Contaminated applicators can cause skin or soft tissue infections, or more serious infections, and no injuries have been reported.

Moderate·FDA·Sep 9, 202613 products

Medline is recalling 16 convenience kit products that contain BD ChloraPrep Clear or FREPP Clear antiseptic applicators. Wrinkles in the paper lidding may extend to the seal, which could break the sterile packaging and allow microbial contamination. No injuries have been reported.

Moderate·FDA·Sep 9, 202616 products

Medline is recalling 11 groups of surgical convenience kits. The kits contain a component that the manufacturer recalled because it may be contaminated. No injuries have been reported, and the kits were distributed in 18 states.

Moderate·FDA·Sep 2, 202611 products

Medline Industries distributed 45 tracheostomy tube kits (SKU DYKM2330) with incorrect component labeling. The discrepancy between the kit label and its contents could lead to confusion during use. No injuries have been reported.

Moderate·FDA·Sep 2, 2026

Medline is recalling specific lots of its medical convenience kits that contain Pilling Wecksorb Neurosponges and Neurosponge Strips. The neurosponges may have endotoxin levels above specification. The recall covers four product groups, about 6,950 kits in total, distributed in several US states. No injuries have been reported.

Moderate·FDA·Sep 2, 20264 productsExpanded Sep 30

Medline is recalling three neonatal and infant heated wire breathing circuit products, about 417,000 units in total. The heated wire connector at the humidifier can fail and show discoloration, melting, smoke, or a burning odor. Failure could cause breathing problems in infants, and no injuries have been reported.

Serious·FDA·Sep 2, 20263 products

Medline is recalling four sizes of Micro-Kill Bleach Germicidal Bleach Wipes, about 1.07 million units in total. The bleach concentration in the wipes may drop below the labeled level before the 12-month shelf life ends, which could reduce their ability to kill germs.

Moderate·FDA·Aug 19, 20264 products

Medline Industries recalled Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits because the electrical connector at the Neptune humidifier can overheat, causing discoloration, melting, smoke, or burning. When this happens, the device automatically shuts off the heated wire function, which means infants may receive unheated or unconditioned breathing gas that can damage the airway and increase the risk of respiratory complications.

Moderate·FDA·Aug 5, 2026

Medline is recalling specific medical convenience kits that include BD PurPrep 26 mL antiseptic skin prep. The prep may contain low levels of Bacillus bacteria. The recall covers four product listings, and no injuries have been reported.

Moderate·FDA·Jul 29, 20264 products

Medline is recalling nine urology convenience kits that contain Bard Silastic Foley catheters. The catheter maker recalled them because they have higher than intended amounts of raw material on the surface, which can cause staining and may be harmful. The kits were distributed nationwide, with confirmed distribution in California, Florida, Maryland, Pennsylvania, and Texas, and no injuries have been reported.

Moderate·FDA·Jul 29, 20269 products

Medline is recalling 370 medical procedure convenience kits across two product entries. The kits include pain management kits made by ICU Medical that contain bupivacaine hydrochloride in dextrose injection, which was recalled over quality issues that could make the drug less effective. No injuries have been reported, and the kits were distributed in Missouri, Colorado, and Illinois.

Serious·FDA·Jul 29, 20262 products

Medline is recalling three kit products that contain a bupivacaine hydrochloride injection, a numbing medication used in surgery. The bupivacaine maker issued a voluntary recall over quality issues, so Medline is recalling the kits that include it. About 2,417 kits are affected, distributed in OH, CA, IL, IN, FL, SC, AZ, and NJ.

Serious·FDA·Jul 29, 20263 products

Medline is recalling two total knee kits, with 163 units of each, because the Zimmer Biomet mixing bowls and spatulas packed inside were recalled for seal problems that could break sterility. Distribution was limited to California and Utah. No injuries have been reported, and the likely health effect is a short delay in surgery while another device is found.

Moderate·FDA·Jul 22, 20262 products

Specific lots of Medline reprocessed St. Jude Medical Response diagnostic electrophysiology catheters may contain small particles of residual material on surfaces that contact patients. If these particles dislodge during use, they could potentially cause blood clots, inflammation, or infection.

Serious·FDA·Jul 8, 2026

Medline is recalling 8 convenience kits that contain Swan-Ganz catheters made by Becton Dickinson (BD). BD received complaints that the blue hub on these catheters can leak or break, which may lead to infection, medication loss, or blood loss. No injuries have been reported, and the kits were distributed in AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, and WI.

Moderate·FDA·Jul 8, 20268 products

Medline is recalling 15 convenience kits that contain Huons lidocaine ampules. Huons issued the recall after an FDA inspection of its manufacturing site found quality problems with the ampules. No injuries have been reported.

Moderate·FDA·Jul 8, 202615 products

Medline is recalling 16 convenience kits that contain 10mL polycarbonate colored syringes. The company found design changes to these kits that were not cleared by the FDA, and the products were not included in an earlier report. The kits were shipped nationwide and to Barbados, and no injuries have been reported.

Moderate·FDA·Jul 1, 202616 products

Medline is recalling four groups of convenience kits, 7,738 units in total, because they include lidocaine and bupivacaine injections from supplier Arrow. Those injections were recalled after an FDA inspection of the supplier found quality issues. No injuries have been reported.

Serious·FDA·Jul 1, 20264 products

Medline recalled 30 products, including urethral catheters, catheterization trays, intermittent latex catheters, and medical procedure kits. During an internal review, the company found that some samples did not meet performance specifications, including surface irregularities, connectors that detached early from the catheter funnel, and some catheters with outer diameters outside specification. No injuries have been reported.

Moderate·FDA·Jun 24, 202630 products