Maine recalls

Philips has found that the wired foot switch on certain ALLURA Xper FD20 operating room tables may fail to start X-ray imaging or may work only intermittently. This affects 4 units worldwide. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 surgical X-ray tables. The switch may fail to start X-ray imaging or may cause imaging to work only intermittently, which could disrupt surgical procedures. This affects 196 units worldwide.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 Biplane X-ray systems where imaging may not start or may work intermittently. This affects 461 units worldwide, including 198 in the US. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 X-ray systems where imaging may not start or may start intermittently. This affects specific serial numbers across three system codes. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD10/10 X-ray systems where imaging may not start or may work on and off intermittently. This affects 112 systems distributed worldwide, identified by specific serial numbers.

Philips has identified a defect in the wired foot switch on certain ALLURA Xper FD10 X-ray imaging systems that may prevent X-ray imaging from starting or cause it to work intermittently. This could delay or disrupt imaging procedures. Philips is working with healthcare facilities to resolve the issue.

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD10F X-ray imaging systems. The foot switch may fail to start X-ray imaging or may cause imaging to work intermittently, which could affect clinical procedures. The issue affects 10 systems total, with no injuries reported.

Philips has identified a problem with the wired foot switch on certain Allura Xper FD10C X-ray imaging systems. When using the foot switch, X-ray imaging may not start or may start intermittently, which could affect clinical workflow. This affects a small number of systems worldwide.

Siemens has recalled certain lots of its Atellica CH A1c_E hemoglobin test kit because when used with another reagent (RCRP) on the same analyzer, the A1c test may give lower-than-accurate results. Lower results could delay diabetes diagnosis or lead to inadequate treatment. This issue does not affect labs using separate analyzers for each test.

ReCor Medical distributed 24 units of Paradise ultrasound renal denervation catheters (Model PRDS-068-02) that did not meet quality standards and were supposed to be destroyed, not sold. The devices were distributed in nine states: California, Colorado, Florida, Kansas, Missouri, North Carolina, Ohio, Texas, and Virginia. No injuries have been reported.

ReCor Medical distributed one Paradise ultrasound renal denervation catheter (Model PRDS-068-02, Lot M4907) that did not meet manufacturing standards and was supposed to be destroyed. The device was distributed in nine U.S. states. No injuries have been reported.

Philips Respironics has recalled certain Trilogy Evo Universal home ventilators (Software Version 1.05.15.00) because the obstruction alarm may not trigger as quickly as safety standards require. In some cases, the alarm could be delayed by up to four breaths, which may prevent timely notification of a breathing tube blockage.

Philips Respironics has recalled certain Trilogy EV300 home ventilators (software version 1.05.15.00) because the obstruction alarm may not trigger quickly enough if the breathing tube becomes blocked. In rare cases, the alarm could be delayed by up to four breaths, which is longer than safety standards allow.

Some Philips Respironics Trilogy Evo O2 ventilators with software version 1.05.15.00 may not sound an obstruction alarm quickly enough if the breathing tube becomes blocked. The alarm could be delayed by up to four breaths, which could reduce the time available to respond to a blockage.

Some Philips Respironics Trilogy Evo home ventilators with Software Version 1.05.15.00 may not sound their obstruction alarm quickly enough if the breathing tube becomes blocked. The alarm could be delayed by up to four breaths, which could reduce the time a user has to respond to an airway obstruction.

Abiomed's Impella Controller may display a delayed "Purge System Blocked" alarm when used with first-generation Impella 5.5 pumps. This could prevent timely detection of a blocked purge system. The issue affects 62 controllers with specific serial numbers in software versions 8.2.2 through 8.5.

Abiomed is recalling purge cassettes used in Impella heart pump systems because Generation 1 cassettes have an increased risk of leaking during use. This affects multiple Impella pump models sold globally, with specific batch numbers identified from 2024.

Lone Star Dairy Products LLC is recalling spray dried milk powder products because Salmonella bacteria was found during testing of finished products. The recall affects specific lot codes of NFDM Low Heat, NFDM High Heat, and SMP Medium Heat products sold in 25 kg bags and 1 metric ton totes.

Some cartons of Amneal Magnesium Sulfate IV bags were mislabeled and contained Tranexamic Acid (a different medication) instead. This mix-up affects lot AH250162 with an expiration date of 8/31/2027. The error was discovered before the product reached patients.

Appco Pharma LLC is recalling specific lots of prazosin hydrochloride 5mg capsules because they contain higher-than-acceptable levels of a nitrosamine impurity (N-nitroso-prazosin). Nitrosamines are chemical contaminants that may increase health risks with long-term exposure. This is a manufacturing quality issue, not a safety defect in the drug itself.

Appco Pharma LLC is recalling specific lots of prazosin hydrochloride 2mg capsules because they contain higher-than-allowed levels of a nitrosamine impurity called N-nitroso-prazosin. Nitrosamines are chemicals that may increase cancer risk with long-term exposure. No injuries have been reported so far.

Appco Pharma LLC is recalling prazosin hydrochloride 1mg capsules (100-count bottles) because they may contain higher-than-acceptable levels of a nitrosamine impurity. This impurity was detected during manufacturing quality checks. The recall affects specific lot numbers distributed nationwide.

Multiple brands of artificial tears eye drops made by K.C. Pharmaceuticals have been recalled because the manufacturer cannot confirm the product is sterile. The affected drops are sold under store brands including Leader, Good Sense, Good Neighbor Pharmacy, TopCare, Best Choice, Kroger, Publix, and Quality Choice. No injuries have been reported.

K.C. Pharmaceuticals issued a recall of Rugby Lubricating Eye Drops and Walgreens Lubricant Eye Drops because the manufacturer cannot guarantee the products are sterile. Non-sterile eye drops can introduce bacteria or other microorganisms into the eye. The recall affects specific lots (SY24K01 and SY24K02) with expiration dates of 09/30/26.

K.C. Pharmaceuticals has recalled multiple brands of sterile redness relief eye drops because they may not meet sterility standards. The affected products were distributed nationwide under various store and pharmacy brand names. No injuries have been reported so far.

K.C. Pharmaceuticals issued a recall of sterile eye drops sold under multiple brand names (including Walgreens, Good Sense, Kroger, CVS, and others) because the manufacturer cannot confirm the products remain sterile. The affected bottles were distributed nationwide. No injuries have been reported.

K.C. Pharmaceuticals is recalling multiple brands of ultra lubricating eye drops sold nationwide because the manufacturer cannot guarantee the drops are sterile. The affected products were distributed under names including Leader, Harris Teeter, Foster & Thrive, Walgreens, CVS Health, Kroger, Publix, Meijer, Good Sense, Quality Choice, and Avenova. No injuries have been reported.

K.C. Pharmaceuticals is recalling Dry Eye Relief Eye Drops sold under multiple store brands including Geri Care, TopCare, Rite Aid, Leader, and others due to concerns that the product may not be sterile. The recall affects 15 mL bottles with specific lot numbers and expiration dates sold nationwide.

K.C. Pharmaceuticals' Advanced Relief eye drops in 0.5 fl oz bottles may not be sterile due to a manufacturing issue. The affected products were sold under multiple store brands at Walgreens, Kroger, CVS, and other retailers nationwide. No infections have been reported so far.

K.C. Pharmaceuticals has recalled multiple brands of sterile eye drops (including Best Choice, Quality Choice, Discount Drug Mart, Good Sense, Walgreens, CareOne, Equaline, TopCare, Meijer, and H.E.B.) because the manufacturer cannot guarantee the products are sterile. Non-sterile eye drops can introduce infection into the eye. The affected products were distributed nationwide and have lot number AC24E01 with expiration date 05/31/26.