Archive
525 recalls were announced in September 2025.
Of the 525 recalls this month scored against our rubric, 13% are Critical, 10% are Severe.
Which agencies issued them
Artis Pheno image-intensified fluoroscopic X-ray systems are recalled because of limited system movements after startup. 20 units are affected.
The Preventive Maintenance Kit ICEFX, batch 108159110, is recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. One unit is affected.
NOxBOXi Nitric Oxide Delivery Systems are recalled for replacement of the internal sample pump because of high failure rates. 1,667 units are affected.
CorNeat EverPatch permanent tissue-integrating surgical matrices are the subject of a retroactive labeling correction, following complaints, to include prevention and management of wound dehiscence.
ReQuest Measles IgM ELISA kits, catalog number 01-190M, are recalled because the test kit lacks premarket approval or clearance. 376 kits are affected.
Organic BABY bedtime drops, a liquid dietary supplement for ages 4 months and up, are recalled in lots 25084 and 25086 because of the potential for spoilage due to yeast contamination. 85,248 bottles are affected.
PILLAR SA Ti sterile 37 mm intervertebral body fusion devices are recalled because the outer and inner label side flaps state an incorrect width of 33 mm. 3 units are affected.
Sulfamethoxazole and Trimethoprim double strength unit dose cartons from Major Pharmaceuticals are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected on any tablets.
Hershey's Ice Cream Green Mint Chip bulk 3-gallon cans, lot 25223M, are recalled after routine testing found elevated coliform counts. 81 cans are affected.
Anabolic Research WINN-50, 90 capsules, lot 2307149, is recalled nationwide because degradation of an ingredient left the product subpotent for vitamin B12. 1,566 bottles are affected.
Neuroquell and Neuroquell Plus, 0.22 fl oz, distributed by Claire Ellen Products, are recalled for cGMP violations. 72 containers sold via the internet are affected.
Sulfamethoxazole and Trimethoprim double strength tablets distributed by Cardinal Health are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected on any tablets.
ZF North America is recalling manual transmissions with an insufficient weld that may cause fluid leaks and loss of drive power or park function.
Quality Poultry & Seafood, Inc. is recalling approximately 98,916 pounds of catfish fillet products produced without federal inspection. The products were distributed to restaurants and retail locations in Alabama, Mississippi, and Louisiana.
Polestar is recalling certain 2021-2025 Polestar 2 vehicles because the rearview camera image may not display when the vehicle is placed in reverse.
Autoliv is recalling front seat belt assemblies where a damaged torsion bar may prevent proper occupant restraint during a crash.
Ford is recalling 2016-2019 Taurus vehicles because the B-pillar door trim may detach while driving, creating a road hazard and increasing crash risk.
Daimler Vans USA is recalling 2024 Mercedes-Benz Sprinter 2500 and 3500 vehicles because longitudinal frame members may not be reinforced properly, potentially reducing crash performance.
Forest River is recalling certain 2025-2026 Spirit and Shasta Oasis recreational trailers because the 30 or 50 amp inlet wire sheathing may be inconsistently stripped, causing electrical arcing. 502 units are affected.
Ford is recalling 2015-2017 Mustangs because water and road salt may corrode front seat belt anchor pretensioner cables, increasing injury risk in a crash.
Orange EV is recalling 1,378 electric trucks because hazard warning lights may turn off when the ignition is off, increasing crash risk.
Yamaha is recalling 2024-2025 Skeeter FXR boat trailers because incomplete welds on the boarding ladder can cause failure, posing injury and crash risks.
Ford is recalling certain 2024 Bronco and Ranger vehicles because the bolts securing the high pressure fuel pump may not be tightened properly, which can result in a fuel leak. 9 units are affected.
Daimler Trucks North America is recalling a range of Freightliner, Western Star and FCCC vehicles over brake caliper mounting bolts, which can lead to a loss of brake function. 402 units are affected.
Micro Bird is recalling 2023-2025 G5 buses because door attachment rings may delaminate, causing doors to open unexpectedly and risking passenger injury.
About 110,000 Paris Hilton Mini Beauty Fridges are recalled because the electrical switch can short circuit and overheat. The firm has 27 reports of the fridge overheating and catching fire, with property damage.
Daimler Trucks North America is recalling certain Freightliner, Western Star, FCCC and Thomas Built vehicles because the tie rod castle nut and cotter pin may be improperly installed. 343 units are affected.
KTM North America is recalling certain Husqvarna Svartpilen 401, Vitpilen 401 and KTM 390 Adventure motorcycles because water could enter the e-throttle control unit and cause loss of drive power. 9,070 units are affected.
Chrysler is recalling 2018 Ram 1500, 2500, and 3500 vehicles because side curtain air bag inflators may rupture, potentially causing injury from metal fragments.
Daimler Trucks North America is recalling 2025-2026 Thomas Built Buses Saf-T-Liner C2 and Jouley models because brake caliper bolts may loosen, risking brake failure.
Hyundai is recalling certain 2025 IONIQ 5 electric vehicles because rear suspension alignment adjustment bolts may have been improperly tightened, which can cause a loss of vehicle stability control. 8 units are affected.
Daimler Trucks North America is recalling certain 2025-2026 Thomas Built Buses school buses because improperly installed steering fasteners may cause a loss of steering control.
Hyundai is recalling certain 2020-2025 Palisade vehicles because the driver, passenger and second-row window seat belt buckles may fail to latch. 568,580 units are affected.
GM is recalling certain 2026 Chevrolet Silverado EV and GMC Sierra EV vehicles because the ESC malfunction warning light may not illuminate after a fault, failing to comply with FMVSS 126. 1,191 units are affected.
Villa International is recalling certain pedestals and seat anchorages because improper welding may cause the seat assembly to loosen or detach, increasing the risk of injury.
Hyundai is recalling certain 2023-2025 IONIQ 6 electric vehicles because the charging port door panel may detach, creating a road hazard. 31,042 units are affected.
About 1,900 Shierdu children's wooden building block cactus toys are recalled because the toy is intended for children under three and contains small parts, violating the small parts ban.
About 4,700 Bariatric Fusion multivitamin bottles containing 45 mg of iron are recalled because their caps are not child-resistant, violating the Poison Prevention Packaging Act.
About 350 In My Jammers children's button up flare pajama sets are recalled because they violate mandatory standards for children's sleepwear flammability, posing a burn risk. No incidents reported.
Aprilia is recalling 720 2026 RSV4 and Tuono sports motorcycles because turn signals and tail lights may flicker or stop working, increasing crash risk.
Chrysler is recalling certain 2022-2025 Jeep Wagoneer and Grand Wagoneer vehicles because improperly installed door trim can detach and create a road hazard. 163,735 units are affected.
Micro Bird is recalling 2,454 school and transit buses because a door component may delaminate, causing the door to open unexpectedly and increasing injury risk.
Toyota is recalling a wide range of 2023-2025 Toyota and Lexus vehicles because an instrument panel software error at startup can leave the display without critical information. 591,377 units are affected.
Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, OUS, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Taylor Farms Honey Balsamic Salad Kits, 8.3 oz, are recalled for undeclared sesame and soy. The FDA classified the action as Class I. 8,284 cases are affected.
DermaRite KleenFoam Antimicrobial Foam Soap with Aloe Vera is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I. 6,973 cartridges are affected.
DLP Left Heart Vent Catheters, model 12113, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 34,549 units are affected.
IDM-ARLITE-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 25 units are affected.
Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Micro Joystick R-net wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.
The Dexcom G7 CGM iOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.
Boston Scientific is recalling WATCHMAN FXD Curve Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40800BAXUS, over software anomalies causing a blank Run screen or a false motor movement system error. 10,101 units are affected.
Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40700BAX, over software anomalies that may cause a blank Run screen or a false motor movement system error. 22,703 units are affected.
DermaRite DermaKleen Health Care Antiseptic Lotion Soap is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I. 11,321 bag-in-boxes are affected.
IDM-MULTI-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 15 units are affected.
Boston Scientific is recalling WATCHMAN TruSeal Access System DBL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Boston Scientific is recalling WATCHMAN TruSeal Access System ANT after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Boston Scientific is recalling WATCHMAN TruSeal Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation. 340,185 units are affected.
Boston Scientific is recalling WATCHMAN TruSeal Access System DBL after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Boston Scientific is recalling WATCHMAN FXD Curve Access System Dbl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Multi Joystick R-net wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.
DLP Left Heart Vent Catheters, model 12110, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 41,200 units are affected.
IDM-MICRO-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 15 units are affected.
DLP Left Heart Vent Catheters, model 12115, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 25,261 units are affected.
The Dexcom ONE+ iOS CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 39,309 units are affected.
The Dexcom G7 CGM watchOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.
Boston Scientific is recalling WATCHMAN TruSteer Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
B. Braun 0.9% Sodium Chloride Injection USP in 1000 mL containers, lot V3K770, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 47,148 containers are affected.
The Dexcom ONE+ Android CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 41,629 units are affected.
B. Braun Lactated Ringer's Injection USP in 1000 mL containers, lot J4S807, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 46,032 containers are affected.
All-round Joystick R-net Light wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.
Baxter is issuing an urgent correction for Novum IQ Large Volume Pumps over software anomalies that may result in a blank Run screen. 43,922 units are affected.
Boston Scientific is recalling WATCHMAN FXD Curve Access Sys Dbl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
DermaSarra External Analgesic containing camphor 0.5%, lot 40187.2, is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I.
DermaRite PeriGiene Health Care Antiseptic containing chloroxylenol 0.5% is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I.
Dexcom G7 and ONE+ CGM apps are recalled because the app does not give the expected Sensor Failed alert, instead silently ending the session. The FDA classified the action as Class I. 532,821 units are affected.
Boston Scientific is recalling WATCHMAN FXD Curve Access System Sgl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.
Harley-Davidson is recalling certain RH1250S Sportster S motorcycles because the upper triple clamp may fracture, which could cause a loss of control. 8,424 units are potentially affected.
Maple Nut Fudge from The Candy Barn is recalled because the specific tree nut pecan and egg are not listed in the contains statement. 665 packages across the firm's products are affected.
Volvo is recalling 2026 V60, V90, XC60, and XC90 models because damaged seat belt retractors may fail to restrain occupants in a crash.
Clean-tail Coconut Farm Raised Breaded Butterfly Shrimp in bulk master cartons, product of Indonesia, is recalled because it may be contaminated with Cesium-137. 31 cases are affected.
Smiths Medical CADD Yellow Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7300-24, may have weakened medication bag welds that could allow leakage. 289,098 units are affected.
Semaglutide 2.5 mg/mL injection, 4 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 648 vials are affected.
Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 50 mL, product code 21-7301-24, may have weakened medication bag welds that could allow leakage. 211,750 units are affected.
MediHoney HCS Surgical Adhesive Sheet dressings, catalog number 31738, lot 53824, are recalled after packaging failures were identified that could breach the sterile barrier. 4 units are affected.
MediHoney Non-Adhesive Hydrogel Sheet Dressings, catalog numbers 31620 and 31640, are recalled after packaging failures were identified that could breach the sterile barrier. 5,374 units are affected.
MediHoney Paste tubes, catalog numbers 31515 and 31535, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 141,620 units are affected.
HEB 8 oz Blueberry Flavored Yogurt Pretzels, lots 080226 and 080326, are recalled for an undeclared wheat allergen. The recall covers 468 cases of 12 packages each, distributed in Texas.
The USDA FSIS issued a public health alert for Bianco & Sons raw sirloin beef tips because the product labels failed to declare common allergens—specifically sesame and wheat—posing risks to consumers with those allergies.
Semaglutide 2.5 mg/mL injection, 2 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 642 vials are affected.
Panko Style Breaded Butterfly Shrimp in 12 lb master cartons, product of Indonesia, is recalled because the product may be contaminated with Cesium-137. 776 cases are affected.
Sterile Cover 10-Pack Shipper Box Assemblies are recalled because elastic bands in the kit may detach or fracture during surgery, risking retained foreign bodies and surgical site infection. 200 units are affected.
RefleXion X1 systems are recalled because an incorrect software configuration potentially allows more than two treatment fractions within a 12-hour period, which could lead to toxicity. 11 units are affected.
Evergreen Farm Jujube Juice in 4 fl oz foil pouches is recalled for lack of pasteurization and sanitation records. 197 cases distributed in three states are affected.
Chocolate Fudge from The Candy Barn is recalled because egg is not listed in the contains statement. 665 packages across the firm's products are affected.
MediHoney HCS Sheet Dressings, catalog numbers 31612, 31622 and 31644, are recalled after packaging failures were identified that could breach the sterile barrier. 3,583 units are affected.
Philips Azurion systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,861 units are affected.
Medtronic is recalling the InPen App for iOS and Android because software design errors could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. 6,816 units are affected.
MediHoney Hydrogel Adhesive Sheet dressings, catalog numbers 31722 and 31744, are recalled after packaging failures were identified that could breach the sterile barrier. 1,147 units are affected.
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