Tennessee recalls

Several Medline medical convenience kits—including IV start kits, blood culture kits, and pediatric emergency trays—contain sterile applicators with wrinkles in the packaging that may compromise the sterile barrier. If the packaging is damaged, the contents could be exposed to microbial contamination, which could cause infection ranging from minor to serious.

Medline's Ultrasound Breast Pack (Model DYNJ63375C) contains sterilized applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the packaging is damaged, the applicators could be exposed to microbial contamination before use.

Medline Convenience Kits (Model DYNJ906437D) containing BD ChloraPrep and FREPP applicators have wrinkles in the paper packaging that may compromise the sterile barrier. If the packaging is breached, patients could be exposed to microbial contamination.

Medline's IVS Blood Culture Kits (models DYNDH1920 and DYNDH1920A) contain sterile applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the seal is breached, the applicators could be exposed to microbial contamination before use.

Medline Convenience Kits containing BD ChloraPrep Clear and FREPP Clear applicators may have packaging defects—wrinkles in the paper lid that could compromise the sterile barrier. If the packaging is compromised, the sterile applicators inside could be exposed to microbial contamination before use.

Several Medline Convenience Kits contain BD ChloraPrep Clear and FREPP Clear applicators with wrinkled paper packaging that may compromise the sterile barrier. If the packaging is breached, the applicators could be exposed to microbial contamination, which could lead to localized or serious infection in patients.

Two Medline Convenience Kits contain BD ChloraPrep Clear applicators with wrinkles in the paper packaging that may compromise the sterile barrier. If the sterile seal is breached, the applicators could be contaminated with microbes, potentially exposing patients and users to infection.

Diagnostica Stago identified a positive drift in quality control (QC) values in one lot of STA Staclot Protein S reagent within the product's stated 4-hour stability period. This drift could affect the accuracy of test results performed during that window. The issue affects reagent Lot 273074 distributed nationwide.

Halyard medical convenience kits contain Ritmed Neurological Sponges that may have unexpected variability in endotoxin levels. Endotoxins are bacterial substances that can trigger immune reactions in patients. The affected kits were distributed nationwide to surgical facilities.

AVID Medical is recalling 70 different neurological and spine surgical kits that contain Ritmed Neurological Sponges. The sponges may have unexpected variability in endotoxin levels, which could affect their safety and sterility during surgical use.

Halyard medical convenience kits contain Ritmed Neurological Sponges that may have unexpected variability in endotoxin levels. Endotoxins are bacterial substances that could trigger an immune response if present at higher-than-expected levels. About 11,763 kits across multiple surgical specialties are affected.

Philips has identified an unintended radiation issue affecting Philips Brilliance CT 64 CT scanner systems (Software 4.1.10.x) that could impact equipment performance. The issue affects multiple Philips CT system models including IQon, iCT, Ingenuity, and Brilliance CT 64.

Philips has identified an unintended radiation issue affecting Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could impact equipment performance. The issue affects specific software versions and product codes distributed in the US and US territories.

Philips has identified an unintended radiation issue affecting the IQon Spectral CT and related CT systems (iCT, Ingenuity, and Brilliance CT 64 models). This issue could affect the performance of the equipment. The problem was found in software version 4.7.7.x.

Philips has identified an unintended radiation issue affecting Philips Brilliance iCT, Brilliance iCT Upgrades, and Brilliance iCT SP CT scanner systems running software version 4.1.10.x. This issue could affect the performance and safety of the equipment.

Savor Seasonings LLC's bulk Organic Cheddar Type Seasoning tested positive for milk allergen that was not listed on the label. The affected product is packaged in 50-lb bags and distributed in Canada. This poses a serious risk to people with milk allergies.

The Hampton Grocer's Lacnola Small Batch Lactation Granola (8 oz pouches) may be contaminated with Salmonella. Two specific lot codes are affected: HGLC-102125 (expires 21 Oct 2026) and HGLC-021326 (expires 13 Feb 2027).

Teva Pharmaceuticals discovered that some bottles of trazodone 50 mg tablets contain foreign tablets or capsules mixed in with the correct medication. The issue affects one lot (1394026) with an expiration date of February 2028. No injuries have been reported.

Supernus Pharmaceuticals is recalling one lot of Trokendi XR (topiramate) 50 mg extended-release capsules because the medication did not dissolve as designed. When a medication fails to dissolve properly, the body may not absorb the full dose, potentially reducing its effectiveness.

Mylan Pharmaceuticals is recalling specific lots of Mycophenolate Mofetil for injection (500 mg/vial) because the medication failed to meet dissolution specifications—meaning the drug may not dissolve properly in the body. This could affect how well the medicine works. The recall affects two lots distributed nationwide.

Testing by Allies Group found that certain batches of The ONE SPF 50 Invisible Sunscreen Gel may not provide the SPF 50 sun protection stated on the label. The affected product was distributed nationwide in the U.S. No injuries have been reported.

Testing found that Allies Group THE ONE SPF 50 Invisible Sunscreen Gel may not provide the advertised SPF 50 sun protection. The product was distributed nationwide in the U.S. The affected sunscreen was made in the U.S.A and distributed by Allies Group Pte Ltd.

Testing found that THE ONE SPF 50 Invisible Sunscreen Gel sachets may not provide the SPF 50 sun protection stated on the label. The affected product was distributed nationwide in the U.S. No injuries have been reported.

Testing by Allies Group Inc. found that The One SPF 50 Invisible Sunscreen Gel may not provide the full SPF 50 sun protection stated on the label. The affected product was distributed nationwide in the U.S. across multiple lot codes with expiration dates through June 2029.

Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets (10 mg/10 mg, 100-count bottles) because some bottles contain unidentified foreign tablets or capsules mixed in with the correct medication. The affected lot is DMA25006 with an expiration date of 11/30/2028. This issue was discovered during quality control.

Baxter Healthcare is recalling one lot of Daptomycin in 0.9% Sodium Chloride Injection due to deviations from current good manufacturing practice (CGMP) standards during production. The affected lot (NC193856, expiring 04/18/2028) was distributed nationwide, Puerto Rico, and Chile.

Baxter Healthcare Corporation is recalling one lot of Vancomycin Injection (NDC 0338-3583-01, Lot #NC193894) due to deviations from good manufacturing practices (CGMP). The affected lot was distributed nationwide in the US, Puerto Rico, and Chile.

Baxter Healthcare Corporation is recalling three lots of Vasopressin injection due to manufacturing process deviations that do not meet FDA quality standards. The affected lots were distributed nationwide, in Puerto Rico, and Chile. No injuries have been reported.

Baxter Healthcare Corporation is recalling one lot of Clindamycin Injection USP in 5% Dextrose due to deviations from manufacturing quality standards. The affected lot was distributed nationwide, in Puerto Rico, and Chile.

Baxter Healthcare Corporation is recalling one lot of Clindamycin Injection USP in 5% Dextrose (900 mg/50 mL) due to deviations from current good manufacturing practices (CGMP). The affected lot was distributed nationwide, in Puerto Rico, and Chile. No injuries have been reported.