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Medical saline recalled over potential fiberglass contamination. ByVictoria Forster, Contributor. Cancer biologist, patient engagement specialist, cancer survivor Aug 28, 2026, 04:28pm EDT Aug 28, 2026, 04:37pm EDT Summary. The FDA has announced a recall of two lots of Baxter International's 0.9% Sodium Chloride Injection, USP, a widely used intravenous saline solution. The recall is due to potential fiberglass particle contamination, which poses severe health risks including blood clots, organ damage, or even death if administered. The affected 500 mL bags, lot numbers Y495523 and Y495523A with an October 2027 expiration, were distributed across 14 states. Although no adverse events have been reported, the FDA warns of dangers like pulmonary embolism and allergic reactions. This marks the latest in a series of Baxter recalls concerning particulate contamination in injectable medical products. The U.S. Food and Drug Administration (FDA) has published a recall notice for bags of intravenous saline over concerns that the solution may contain fiberglass particles, contamination that could potentially cause blood clots, organ damage or death if administered to patients. The voluntary product recall covers two lots of '0.9% Sodium Chloride Injection, USP,' a commonly used sterile medical saline solution supplied by Baxter International in 500 mL plastic bags. According to the recall notice, the affected products have lot numbers Y495523 and Y495523A and an expiration date of October 31, 2027. The affected products were distributed to healthcare providers and distributors in 14 states between July 31 and August 3 2026, according to the company. Intravenous saline is one of the most widely used medical fluids, with applications ranging from treating dehydration and delivering medications to supporting patients undergoing medical procedures. If administered intravenously, particles in the bloodstream can have serious consequences. The FDA notice warns that particulate matter could cause blockages and clotting in blood vessels, potentially cutting off blood flow to vital organs. This could result in a pulmonary embolism, a potentially life-threatening blood clot in the lungs, as well as permanent organ damage or death. Other possible complications include local vein irritation, inflammation, worsening of existing infections and allergic reactions. Despite the potentially serious risks, Baxter said it had received no reports of adverse events related to the recalled lots as of August 25. The recall is the latest in a series of recent incidents involving injectable medical solutions with potential particulate contamination. Earlier this week, the company recalled one lot of anticoagulant sodium citrate solution over the potential presence of fiberglass particles and an injectable nutrition product over the potential presence of stainless steel particles. The Prompt: Get the week's biggest AI news on the buzziest companies and boldest breakthroughs, in your inbox.

Baxter issues voluntary nationwide recall for two lots of 0.9% Sodium Chloride Injection due to potential presence of particulate matter. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Summary. * Company Announcement Date: - August 25, 2026 * FDA Publish Date: - August 26, 2026 * Product Type: - Drugs * Reason for Announcement: - Potential presence of particulate matter identified as fiberglass in the solution. * Company Name: - Baxter International Inc. * Brand Name: - Baxter * Product Description: - 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container Company Announcement. FOR IMMEDIATE RELEASE - AUG. 25, 2026 - DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling two lots of 0.9% Sodium Chloride Injection due to the potential presence of particulate matter identified as fiberglass in the solution. Risk Statement: Intravenous administration of 0.9% Sodium Chloride Injection containing fiberglass particulate matter may lead to serious adverse health consequences. Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions. As of 8/25/2026, Baxter has not received any reports of adverse events related to this issue. The product is indicated as a source of water and electrolytes and is also indicated for use as a priming solution in hemodialysis procedures. The product is packaged in 500 mL VIAFLEX Plastic Containers, with 24 units per case. Additional information can be found in the table below. Affected Product: | Product Code | Product Description | Lot Number | Expiration Date | NDC Number | | 2B1323Q | 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container | Y495523 | 31-Oct-2027 | 0338-0049-03 | | Y495523A | The affected lots can be identified by locating the lot number and expiration date on the individual product and shipping carton, as shown in the images below. The impacted product was distributed from 7/31/2026 to 8/3/2026 to healthcare providers and distributors to select states in the United States, including Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas, and Virginia. Customers should immediately discontinue use of and return all affected units in accordance with their facility's process. Baxter is contacting customers by email with instructions on how to identify and return the impacted product. Consumers with questions regarding this recall can contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. * Complete and submit the report Online: www.fda.gov/medwatch/report.htm * Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm[2] or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 The United States Food and Drug Administration (FDA) has been notified of this action. Company contact information. * Consumers: - Baxter Healthcare Center - 888-229-0001 * Media: - Brenna Byrne - (224) 948-5353 - [email protected]

Baxter issues voluntary nationwide recall for one lot of Anticoagulant Sodium Citrate Solution due to potential presence of particulate matter. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Summary. * Company Announcement Date: - August 25, 2026 * FDA Publish Date: - August 25, 2026 * Product Type: - Drugs * Reason for Announcement: - Potential presence of particulate matter identified as fiberglass in the solution * Company Name: - Baxter International Inc. * Brand Name: - Baxter * Product Description: - Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container Company Announcement. FOR IMMEDIATE RELEASE - AUG. 25, 2026 - DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter identified as fiberglass in the solution. Risk Statement: Anticoagulant Sodium Citrate Solution is intended for use with automated apheresis devices. Administration of Anticoagulant Sodium Citrate containing particulate matter may lead to adverse health consequences, the extent and severity of harm depend on the size, number, morphology and composition of the foreign material. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory or hypersensitivity reactions, and systemic embolization that could result in tissue or organ injury. As of 8/25/2026, Baxter has not received any reports of adverse events related to this issue. The product is intended for use only with apheresis devices. It is not for direct intravenous infusion and the directions for use are contained in the owners operating and maintenance manual of the apheresis machine to be used. The product is packaged in 250 mL VIAFLEX Plastic Containers, with 36 units per case. Additional information can be found in the table below. Affected Product: | Product Code | Product Description | Lot Number | Expiration Date | NDC Number | | 2B7867Q | Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container | Y493475 | 31-Dec-2027 | 0338-9669-01 | The affected lot can be identified by locating the lot number and expiration date on the individual product and shipping carton, as shown in the images below. The impacted product was distributed from 7/2/2026 to 7/11/2026 to one customer in the United States. The customer should immediately discontinue use of and return all affected units in accordance with their facility's process. Baxter is contacting the customer by email with instructions on how to identify and return the impacted product. For general questions regarding this communication, please contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. * Complete and submit the report Online: www.fda.gov/medwatch/report.htm * Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm[2] or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 The United States Food and Drug Administration (FDA) has been notified of this action. Company contact information. * Consumers: - Baxter Healthcare Center - 888-229-0001 * Media: - Brenna Byrne - (224) 948-5353 - [email protected]