Archive
523 recalls were announced in August 2025.
Of the 523 recalls this month scored against our rubric, 7% are Critical, 20% are Severe.
Which agencies issued them
GE HealthCare is recalling SIGNA Premier Elite (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Insightra Ultra IABP Catheter Kits are being recalled because the device carries indications and compatibility claims not reviewed by the FDA, and its instructions are inconsistent with product training.
GE HealthCare is recalling SIGNA PET/MR AIR (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 280 Signa Voyager MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE SIGNA Hero MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE HealthCare is recalling 56 SIGNA Hero MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling SIGNA PET/MR AIR Plus (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Lithium Orotate 20 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
GE HealthCare is recalling 19 Discovery MR450 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Bartels ELISA Legionella Urinary Antigen kits are being recalled because two lots have the potential to contain particulate matter. 968 kits are affected.
Lithium Orotate capsules distributed by Mecene LLC are being recalled as a downstream recall of a dietary supplement ingredient that was manufactured out of specification. About 185,482 capsules affected.
HemosIL LMW Heparin Controls, part number 0020300200, are recalled after complaints of lower than expected quality control recovery. 41,824 units are affected.
GE HealthCare is recalling 138 SIGNA Artist Evo MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 758 SIGNA Architect MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Lithium Orotate 1 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
GE SIGNA Hero Elite MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Zvu Anorectal Manometry Procedure Kits are being recalled because the outer kit label carries an incorrect expiration date, with the manufacturing date used in its place. 8 kits are affected.
GE SIGNA Premier MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
GE SIGNA Premier XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 2 units affected.
Lithium Orotate 10 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
GE HealthCare is recalling 97 SIGNA PET/MR imagers because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 1,372 Optima MR450w 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 330 Discovery MR750 3.0T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 151 SIGNA Architect AIR (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Lithium Orotate 2.5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency. The action follows a recall by the ingredient supplier.
GE Discovery MR750w 3.0T MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 519 units affected.
Lithium Orotate 5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide for failing to meet its labeled potency, following a recall by the ingredient supplier.
GE SIGNA Hero XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
BD is recalling 6,076 Pyxis MedBank and MedBank Mini automated dispensing cabinets after reports of delayed access to medication caused by the override and Add Item workflow.
Triumph is recalling certain 2024-2025 Daytona 660 motorcycles because the engine may fail due to internal damage caused by a disruption of oil flow.
Chrysler is recalling certain 2026 RAM 2500, 3500, 4500 Cab Chassis, and 5500 Cab Chassis vehicles because the instrument panel may display an incorrect brake system warning light, potentially failing to alert drivers to critical safety information.
ESR HaloLock wireless power banks are being recalled because the lithium-ion battery can overheat and ignite. Nine fires and explosions caused about $20,000 in property damage.
Jayco is recalling 2024-2025 Jay Flight SLX travel trailers because a missing furnace exhaust vent may allow carbon monoxide to enter the vehicle.
Wolfgang Puck Stainless Steel Petite Tea Kettles are being recalled because the infuser basket lid is loose and can fall off during use. Five of ten reports involved burns or scalding. About 40,000 units affected.
Werner 20' and 24' Multi-Max Pro multi-purpose ladders are being recalled because the locking mechanism can jam and not fully lock. Eighteen falls and fourteen injuries reported. About 122,250 units affected.
Drinkmate 1L Carbonation Bottles are being recalled because they can explode during use. Eight reports include four resulting in lacerations, impact injuries and hearing damage. About 106,200 units affected.
Altec is recalling 2024-2025 Aerial Device and Digger Derrick vehicles because front winch bumpers may be secured with incorrect bolts, posing a crash and injury risk.
Firefly Safe & Green 32 oz fuel bottles are being recalled because the nozzle applicator is not child-resistant as required for hydrocarbons, and the fuel is incorrectly labeled "Non-Toxic".
Three-tiered spiral children's tower toys are being recalled because the toy contains small balls and is intended for children under three, violating the small ball ban. About 260 units affected.
Electronic LED modules used with floating stairs and rails are being recalled because the module can overheat and melt, posing a fire hazard. About 2,720 units are affected.
Chrysler is recalling 2024-2025 Jeep Wrangler vehicles because a pinched antenna cable may prevent the tire pressure warning light from illuminating, increasing crash risk.
Remington brand hair dryers, model D3190DCDN, are being recalled because they lack an immersion protection device, posing a risk of electrocution or shock if dropped into water. About 56,300 units affected.
BritePro Solo Single-Use Fiber Optic Mini Handles and Blades in Macintosh and Miller sizes are being recalled because the handles may not illuminate as intended.
Bulk pecan pieces and halves are being recalled because the pecans have the potential to be contaminated with Salmonella. 32,670 lbs are affected.
Member's Mark Freeze Dried Fruit Variety Pack 15 count is being recalled after the firm received positive test results for Listeria monocytogenes during routine testing. 21,552 boxes affected.
BD Alaris Pump Infusion Sets are being recalled because the pump module used with them may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.
BD Alaris Pump Module Model 8100 with Guardrails Suite MX software is being recalled because it may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.
BritePro Solo Single-Use Fiber Optic Handles and Blades in Macintosh and Miller sizes are being recalled because the handles may not illuminate as intended.
Microbore Extension Sets with 0.2 Micron Filter are being recalled because the label indicates an air eliminating filter, but the filter fitted is not indicated for air removal. 34,825 US units affected.
Aral Silver Vobla whole dried salted roach fish is being recalled because of Clostridium botulinum in uneviscerated fish. 23 boxes are affected across sixteen states.
Item #1071 Italian layer cake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella. The source does not state a quantity.
The Plum Duo Infusion System is being recalled because two sequences of programming events and alarm interactions may cause the user interface to become unresponsive. 4,677 units are affected.
Volkswagen is recalling certain 2025 Tiguan vehicles because a tie rod bolt on the rear axle assembly may be loose, which can lead to a loss of vehicle control. 15 vehicles are affected.
Item #99272 Tres Leches Cheesecake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella.
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.
Item #3145 Hummingbird Layer Cake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella.
BritePro Solo Single-Use Fiber Optic Laryngoscope Handles, REFs 040-310AU and 040-310U, are being recalled because the handles may not illuminate as intended.
Item #1312 Carrot layer cake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella.
Parashore Pear Slices in Juice, 15 oz, are being recalled because the product is contaminated with elevated lead and cadmium. 8,160 units are affected.
BritePro Solo Mini with Pro Miller Blade Size 1.5 is being recalled because the laryngoscope handles may not illuminate as intended.
Item #2485 Assorted layer cake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella.
Item #99273 chocolate Tres Leches Cheesecake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella.
Favorite Day Bakery Frosted Sugar Cookies, 10 count, are being recalled because of foreign material, specifically wood. 803 cases are affected.
Queen Bee Gardens Whipped Honey Pure in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 112 jars are affected.
One-piece Guedel airways, size 2, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 2,800 pieces are affected.
Pinnacle 3 with TumorLOC Radiation Therapy Planning System software is being recalled because a software issue may provide incorrect dataset calculations when performing the Stopping Power Ratio. 149 serial numbers affected.
The Unsaturated Iron Binding Capacity assay is being recalled because it is not meeting the labeled hemoglobin interference claims stated in its instructions for use. 56,696 units affected.
Stryker SmartPump Tourniquet disposable cuffs are being recalled because the cuff flange may become detached from the bladder, which the manufacturer links to a risk of hemorrhage if a leak occurs during a procedure.
Doxepin Hydrochloride Capsules USP 10 mg from Alembic are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 9,492 bottles affected.
Queen Bee Gardens Whipped Honey Raspberry in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 129 jars are affected.
One-piece Guedel airways, size 3, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 8,640 pieces are affected.
Semaglutide + Cyanocobalamin 0.22 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 290 vials are affected.
Tirzepatide + Niacinamide 4.4 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 170 vials are affected.
Semaglutide + Cyanocobalamin 1.5 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 190 vials are affected.
Tirzepatide + Niacinamide 11.24 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 146 vials are affected.
epoc BGEM BUN Test Cards are being recalled because a negative sodium bias may exist in some lots, with an observed average bias of -4.4 mmol/L. 37,554 units are affected.
Semaglutide + Cyanocobalamin 0.44 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 221 vials are affected.
DASH SARS-CoV-2 & Flu A/B Tests are being recalled because a manufacturing error means the assay may result in a missed diagnosis or delay of treatment through a potential false negative. 710 units affected.
Tirzepatide + Niacinamide 8.8 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 139 vials are affected.
Tirzepatide + Niacinamide 16.6 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 155 vials are affected.
Tirzepatide + Niacinamide 6.6 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 160 vials are affected.
Duloxetine Delayed-Release 30 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 875 bottles affected.
Queen Bee Gardens Whipped Honey Huckleberry in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 24 jars are affected.
Frederik's by Meijer Artisan Baked Sea Salt flatbread crackers, 5.5 oz, are being recalled because of undeclared sesame. 1,790 retail units are affected.
Breaded Jalapeno Mac & Cheese Bites in 30 lb cases are being recalled because a supplier recalled an ingredient used in the finished product for possible Listeria monocytogenes contamination. 819 cases affected.
Cesarina Mediterranean Mix Cookies, 16 oz, are being recalled because sesame is not listed in the Contains statement. 30 cases are affected.
OH MMB Human Donor Milk is being recalled because of an inaccurate temperature reading from a thermometer on one pasteurization machine. 5,735 units in total are affected.
Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.
Semaglutide + Cyanocobalamin 2.21 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 176 vials are affected.
Duloxetine Delayed-Release 20 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 16 bottles affected.
Semaglutide + Cyanocobalamin 0.88 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 194 vials are affected.
Spironolactone Tablets USP 25 mg are being recalled because of the presence of a foreign substance identified as aluminum. 11,328 bottles are affected.
Tirzepatide + Niacinamide 2.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 236 vials are affected.
Semaglutide + Cyanocobalamin 2.67 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 158 vials are affected.
Tirzepatide + Niacinamide 13.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 143 vials are affected.
Clover Valley One Dozen Grade A Large Eggs are being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 14 units are affected.
Shamrock Farms Whole Milk, 12 fl oz, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 2 units are affected.
Minute Maid Fruit Punch, 59 fl oz, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 4 units are affected.
Milo's Lemonade, 1 gallon, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 1 unit is affected.
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