The Recall Desk

Archive

September 2025 recalls

525 recalls were announced in September 2025.

What the numbers show

Critical
68
Severe
54
High
234
Moderate
98
Low
71

Of the 525 recalls this month scored against our rubric, 13% are Critical, 10% are Severe.

Which agencies issued them

201–300 of 525

  • ModerateFDA (Drugs)·D-0622-2025·2025-09-17

    First aid iodine antiseptic recalled over broken or leaking bottles

    Iodo Blanco Iodides First Aid Antiseptic, iodine 2%, lot 230619, is recalled because of a defective container: broken or leaking bottles. 3,900 bottles distributed in Florida are affected.

    Product
    Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 70242-109-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2552-2025·2025-09-17

    Measles IgM test kits recalled for lacking premarket approval or clearance

    ReQuest Measles IgM ELISA kits, catalog number 01-190M, are recalled because the test kit lacks premarket approval or clearance. 376 kits are affected.

    Product
    Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2555-2025·2025-09-17

    Intervertebral fusion implants recalled over incorrect width printed on side labels

    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.

    Product
    PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2551-2025·2025-09-17

    Preventive maintenance kit recalled over loosely tightened desiccant tube end caps

    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.

    Product
    Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0625-2025·2025-09-17

    Cardinal Health antibiotic tablets recalled over micro-organism on packaging coil

    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.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0626-2025·2025-09-17

    Ciprofloxacin and dexamethasone otic suspension recalled following temperature abuse

    Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, lot VNF35A, distributed by Sandoz, is recalled because of temperature abuse. 1,680 bottles went to a single consignee in California.

    Product
    CIPROFLOXACIN AND DEXAMETHASONE — CIPROFLOXACIN AND DEXAMETHASONE (CIPROFLOXACIN AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2537-2025·2025-09-17

    Surgical matrix patches recalled for labeling correction on wound dehiscence management

    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.

    Product
    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2550-2025·2025-09-17

    Cryoablation systems recalled over desiccant tube caps that were not tightened

    ICEfx Cryoablation Systems are recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. 18 units are affected.

    Product
    ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0579-2025·2025-09-17

    Bulk mint chip ice cream recalled after elevated coliform counts found

    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.

    Product
    Hershey s Ice Cream, Green Mint Chip (GMC) Bulk, 3 gallons, 1 unit , bulk can- a cardboard tub with metal rings and cardboard lid
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·H-0576-2025·2025-09-17

    Baby bedtime drops recalled over potential spoilage from yeast contamination

    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.

    Product
    Organic BABY bedtime drops; sleep + immunity blend; Promotes restful sleep with natural herbs & supports immunity with elderberry & vitamin C; LIQUID DIETARY SUPPLEMENT; AGE 4 MONTHS+, NET WT. 2 OZ (60 ML)
    Category
    Food
    Distribution
    31 states
  • SevereNHTSA·25E058000·2025-09-16

    ZF Manual Transmission Recall for Potential Loss of Drive Power

    ZF North America is recalling manual transmissions with an insufficient weld that may cause fluid leaks and loss of drive power or park function.

    Product
    POWER TRAIN:MANUAL TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·029-2025·2025-09-15

    Quality Poultry & Seafood Recalls Uninspected Catfish Fillet Products

    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.

    Product
    Quality Seafood & Poultry, Inc. — Quality Poultry & Seafood, Inc. Recalls Various Catfish Fillet Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·25V615000·2025-09-15

    Polestar 2 rearview camera may not display when reversing

    Polestar is recalling certain 2021-2025 Polestar 2 vehicles because the rearview camera image may not display when the vehicle is placed in reverse.

    Product
    POLESTAR — POLESTAR POLESTAR 2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V610000·2025-09-12

    Travel trailers recalled because inlet wiring may arc and cause fire

    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.

    Product
    FOREST RIVER — FOREST RIVER SHASTA OASIS, SPIRIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V611000·2025-09-12

    Ford Recalls 2016-2019 Taurus for Detaching B-Pillar Door Trim

    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.

    Product
    FORD — FORD TAURUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V609000·2025-09-12

    Mercedes-Benz Recalls 2024 Sprinter Vans for Frame Reinforcement Defect

    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.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 3500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V612000·2025-09-12

    Orange EV Recalls Electric Trucks Due to Hazard Light Defect

    Orange EV is recalling 1,378 electric trucks because hazard warning lights may turn off when the ignition is off, increasing crash risk.

    Product
    ORANGE EV — ORANGE EV E-TRIEVER, HUSK-E, T-SERIES ELECTRIC TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V603000·2025-09-11

    Trucks and buses recalled over tie rod fasteners risking steering loss

    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.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER, THOMAS BUILT BUSES 49X, BUSINESS CLASS M2, SAF-T-LINER C2, 47X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V597000·2025-09-11

    Ford Bronco and Ranger recalled over fuel pump bolts that may leak

    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.

    Product
    FORD — FORD RANGER, BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V607000·2025-09-11

    Hyundai Palisade recalled because seat belt buckles may fail to latch

    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.

    Product
    HYUNDAI — HYUNDAI PALISADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V605000·2025-09-11

    IONIQ 5 recalled over rear suspension bolts affecting vehicle stability control

    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.

    Product
    HYUNDAI — HYUNDAI IONIQ 5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25459·2025-09-11

    Mini beauty fridges recalled after 27 reports of overheating and fire

    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.

    Product
    Paris Hilton Mini Beauty Fridges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V601000·2025-09-11

    Commercial trucks recalled over brake caliper bolts risking loss of braking

    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.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR, FCCC BUSINESS CLASS M2, CASCADIA, 47X, MT50E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V602000·2025-09-11

    Thomas Built Buses Recalls 2025-2026 Saf-T-Liner C2 Models for Brake Defect

    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.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER C2 JOULEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V604000·2025-09-11

    Thomas Built Buses Recalls School Buses Due to Steering Defect

    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.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2 JOULEY, SAF-T-LINER C2, SAF-T-LINER HDX, SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V599000·2025-09-11

    Micro Bird Recalls G5 Buses Due to Door Mechanism Defect

    Micro Bird is recalling 2023-2025 G5 buses because door attachment rings may delaminate, causing doors to open unexpectedly and risking passenger injury.

    Product
    MICRO BIRD — MICRO BIRD G5 TRANSIT BUS, G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V592000·2025-09-11

    Chrysler Recalls 2018 Ram Trucks Due to Air Bag Inflator Defect

    Chrysler is recalling 2018 Ram 1500, 2500, and 3500 vehicles because side curtain air bag inflators may rupture, potentially causing injury from metal fragments.

    Product
    RAM — RAM 2500, 1500, 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V598000·2025-09-11

    Motorcycles recalled because water in the throttle control can cause power loss

    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.

    Product
    HUSQVARNA — HUSQVARNA, KTM SVARTPILEN 401, VITPILEN 401, 390 ADVENTURE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25462·2025-09-11

    Children's pajama sets recalled for violating sleepwear flammability standards

    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.

    Product
    In My Jammers Button Up Flare Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25460·2025-09-11

    Iron multivitamin bottles recalled because caps are not child resistant

    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.

    Product
    Bariatric Fusion Iron Multivitamin Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V594000·2025-09-11

    Electric pickups recalled because stability control warning light may not illuminate

    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.

    Product
    GMC — GMC, CHEVROLET SIERRA EV, SILVERADO EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V593000·2025-09-11

    Jeep Wagoneer models recalled because door trim may detach while driving

    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.

    Product
    JEEP — JEEP GRAND WAGONEER, WAGONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V591000·2025-09-11

    Aprilia Recalls 2026 Sports Motorcycles Due to Tail Light Flickering

    Aprilia is recalling 720 2026 RSV4 and Tuono sports motorcycles because turn signals and tail lights may flicker or stop working, increasing crash risk.

    Product
    APRILIA — APRILIA RSV4 1100 E5+ FACTORY, TUONO 1100 E5+, TUONO 1100 E5+ F, RSV4 1100 E5+
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25461·2025-09-11

    Wooden cactus building block toys recalled over small parts choking hazard

    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.

    Product
    Children's Wooden Cactus Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V600000·2025-09-11

    Micro Bird Recalls School Buses Due to Door Mechanism Defect

    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.

    Product
    MICRO BIRD — MICRO BIRD G5 TRANSIT BUS, G5 SCHOOL BUS, T-SERIES SCHOOL BUS, MB II SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V595000·2025-09-11

    Toyota and Lexus vehicles recalled over instrument panel software display error

    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.

    Product
    TOYOTA — TOYOTA, LEXUS VENZA HYBRID, CROWN, RAV4, CAMRY HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0611-2025·2025-09-10

    External analgesic lotion recalled over Burkholderia cepacia contamination

    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.

    Product
    DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2436-2025·2025-09-10

    TruSteer transseptal access systems recalled over higher air embolism risk

    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.

    Product
    WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2333-2025·2025-09-10

    Syringe pumps recalled over false motor movement system error messages

    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.

    Product
    Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2431-2025·2025-09-10

    WATCHMAN TruSeal access systems recalled over air embolism during transseptal access

    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.

    Product
    WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0628-2025·2025-09-10

    Sodium chloride injection containers recalled over presence of particulate matter

    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.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0616-2025·2025-09-10

    Honey balsamic salad kits recalled over undeclared sesame and soy allergens

    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.

    Product
    Salad Kit labeled as follows: Taylor FARMS Honey Balsamic SALAD KIT, NET WT. 8.3 OZ (235g), INGREDIENTS: HONEY BALSAMIC VINAIGRETTE (soybean oil ...) SPINACH, CARROT, SEA SALT CROISSANT CROUTON (wheat flour ...) CRUMBLED FETA CHEESE (feta cheese [pasteurized milk ...] ...)…
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Devices)·Z-2448-2025·2025-09-10

    Dexcom G7 watchOS app recalled because sensor failure alerts are missing

    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.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2480-2025·2025-09-10

    Left heart vent catheters 13FR recalled because they may not retain shape

    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.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2482-2025·2025-09-10

    Left heart vent catheters recalled because they may not retain shape

    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.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2454-2025·2025-09-10

    Wheelchair joysticks recalled over unintended movement on power-up

    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.

    Product
    Micro Joystick R-net. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2457-2025·2025-09-10

    IDM-MULTI-R wheelchair controls recalled over unintended movement at power-up

    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.

    Product
    IDM-MULTI-R. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2435-2025·2025-09-10

    FXD Curve double access systems recalled over transseptal air embolism risk

    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.

    Product
    WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2334-2025·2025-09-10

    Novum IQ syringe pumps recalled over software anomalies affecting the run screen

    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.

    Product
    Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2432-2025·2025-09-10

    TruSeal DBL access systems recalled over air embolism risk without ventilation

    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.

    Product
    WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2449-2025·2025-09-10

    Dexcom ONE+ Android app recalled over missing sensor failure alerts

    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.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2459-2025·2025-09-10

    IDM-ARLITE-R wheelchair controls recalled over unintended movement on power-up

    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.

    Product
    IDM-ARLITE-R. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2456-2025·2025-09-10

    IDM-MICRO-R wheelchair controls recalled over unintended movement on power-up

    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.

    Product
    IDM-MICRO-R. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2332-2025·2025-09-10

    Novum IQ large volume pumps recalled over software anomalies causing blank screens

    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.

    Product
    Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2447-2025·2025-09-10

    Dexcom G7 iOS app recalled because sensor failure alerts do not appear

    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.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2450-2025·2025-09-10

    Dexcom ONE+ iOS app recalled because sensor failed alerts do not appear

    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.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0610-2025·2025-09-10

    Antiseptic lotion soap recalled over contamination with Burkholderia cepacia

    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.

    Product
    DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2433-2025·2025-09-10

    TruSeal ANT access systems recalled over air embolism risk without 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.

    Product
    WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2428-2025·2025-09-10

    Transseptal access systems recalled over higher air embolism risk without 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.

    Product
    WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2455-2025·2025-09-10

    Multi Joystick wheelchair controls recalled over unintended movement at power-up

    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.

    Product
    Multi Joystick R-net. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2429-2025·2025-09-10

    FXD Curve access systems recalled over air embolism risk during transseptal procedures

    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.

    Product
    WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2458-2025·2025-09-10

    All-round Joystick Light controls recalled over unintended wheelchair movement at power-up

    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.

    Product
    All-round Joystick R-net Light. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2481-2025·2025-09-10

    Left heart vent catheters 10FR recalled because they may not retain shape

    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.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2446-2025·2025-09-10

    Glucose monitor apps recalled because sensor failed alerts do not appear

    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.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0612-2025·2025-09-10

    Antimicrobial foam soap recalled over contamination with Burkholderia cepacia

    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.

    Product
    KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0627-2025·2025-09-10

    Lactated Ringer's injection containers recalled over presence of particulate matter

    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.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2426-2025·2025-09-10

    TruSeal single access systems recalled over transseptal air ingress risk

    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.

    Product
    WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2430-2025·2025-09-10

    FXD Curve access systems recalled over ventilation-related air embolism risk

    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.

    Product
    WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0613-2025·2025-09-10

    Health care antiseptic recalled over contamination with Burkholderia cepacia bacteria

    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.

    Product
    PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2434-2025·2025-09-10

    FXD Curve single access systems recalled over air embolism likelihood

    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.

    Product
    WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2427-2025·2025-09-10

    TruSeal double access systems recalled over air embolism risk under sedation

    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.

    Product
    WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2526-2025·2025-09-10

    CADD 100 mL flow stop reservoirs recalled over weakened bag welds

    Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7302-24, may have weakened medication bag welds that could allow leakage. 987,911 units are affected.

    Product
    Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0567-2025·2025-09-10

    Pecan toffee clusters recalled because pecan is missing from label

    Pecan Toffee Clusters from The Candy Barn are recalled because the specific tree nut pecan is not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    Pecan Toffee Clusters, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 5oz, flexible plastic bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2510-2025·2025-09-10

    MediHoney hydrogel adhesive sheets recalled over sterile barrier packaging failures

    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.

    Product
    Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2025·2025-09-10

    Flow stop cassette reservoirs recalled because medication bag welds may weaken

    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.

    Product
    Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0564-2025·2025-09-10

    Maple nut fudge recalled because pecan and egg are not declared

    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.

    Product
    Maple Nut Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2502-2025·2025-09-10

    Azurion imaging systems recalled because single phase UPS may fail on power loss

    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.

    Product
    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2522-2025·2025-09-10

    CADD 50 mL cassette reservoirs recalled over weakened bag welds

    Smiths Medical CADD Medication Cassette Reservoirs, 50 mL, product code 21-7001-24, may have weakened medication bag welds that could allow leakage. 29,811 units are affected.

    Product
    Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0555-2025·2025-09-10

    Korean pear juice pouches recalled over missing pasteurization and sanitation records

    Evergreen Farm Korean Pear Juice in 4 fl oz foil pouches is recalled for lack of pasteurization and sanitation records. 610 cases distributed in three states are affected.

    Product
    Evergreen Farm Korean Pear Juice, 4 fl. oz. (120ml) , Foil pouches, 25 foil pouches per case, Refrigerate product after opening
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2515-2025·2025-09-10

    Toxoplasma IgM assay kits recalled over risk of false positive results

    Platelia Toxo IgM kits, catalog number 26211, lot 4L0054, are recalled because of a risk of false positive results that could lead to unnecessary medical treatment. 35 kits are affected.

    Product
    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2025·2025-09-10

    Medication cassette reservoirs recalled over weakened bag welds causing leakage

    Smiths Medical CADD Medication Cassette Reservoirs may have weakened medication bag welds along the bag perimeter, which could result in medication leakage. 265,500 units are affected.

    Product
    Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0559-2025·2025-09-10

    Chocolate fudge recalled because egg is missing from the contains statement

    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.

    Product
    Chocolate Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0608-2025·2025-09-10

    Compounded semaglutide 0.8 mL vials recalled after testing subpotent

    Semaglutide 2.5 mg/mL injection, 0.8 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 186 vials are affected.

    Product
    Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0553-2025·2025-09-10

    Coconut breaded butterfly shrimp recalled over possible cesium-137 contamination

    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.

    Product
    Clean-tail Coconut Farm Raise Breaded Butterfly Shrimp Clean Tail (21/25 CT per pound) in bulk packaging, corrugated master cartons. Master carton case (4 x 3lb), KEEP FROZEN. Product of Indonesia, Item# 1SH0468709H
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·H-0563-2025·2025-09-10

    Peanut butter fudge recalled because egg is not listed as allergen

    Peanut Butter 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.

    Product
    Peanut Butter Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0560-2025·2025-09-10

    Chocolate walnut fudge recalled because walnut and egg are undeclared

    Chocolate Walnut Fudge from The Candy Barn is recalled because the specific tree nut walnut and egg are not listed in the contains statement. 665 packages across the firm's products are affected.

    Product
    Chocolate Walnut Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0557-2025·2025-09-10

    Jujube juice pouches recalled over missing pasteurization and sanitation records

    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.

    Product
    Evergreen Farm Jujube Juice, 4 fl. oz. (120ml) , Foil pouches, 25 foil pouches per case, Refrigerate product after opening
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·H-0568-2025·2025-09-10

    Lemon meringue pies recalled because Yellow No. 5 is undeclared

    Lemon Meringue Pie, 8-inch round, is recalled because FD&C Yellow No. 5 is undeclared on the label. The recall covers 136,252 cases distributed at retail across many states.

    Product
    Lemon Meringue Pie, 8" round. Net Wt. 27 OZ; Refrigerate after opening Item Code 31811; UPC: 8 85523 31811 1;Jessie's Lemon Meringue Pie Sugar Free Item Code 30811; UPC: 8 85523 30811 2; Jessie's Lemon Meringue Pie Item Code 08276; UPC: 0 41512 08275 7; First street Lemon…
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·H-0556-2025·2025-09-10

    Grape juice pouches recalled for lack of pasteurization and sanitation records

    Evergreen Farm Grape Juice in 4 fl oz foil pouches is recalled for lack of pasteurization and sanitation records. 78 cases distributed in three states are affected.

    Product
    Evergreen Farm Grape Juice, 4 fl. oz. (120ml) , Foil pouches, 25 foil pouches per case, Refrigerate product after opening
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·H-0561-2025·2025-09-10

    Chocolate mint fudge recalled because egg is not listed as allergen

    Chocolate Mint 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.

    Product
    Chocolate Mint Fudge, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, 10oz, packed in plastic clamshell
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·H-0566-2025·2025-09-10

    Peanut brittle recalled because peanuts and milk are missing from label

    Grandma's Old-Fashioned Peanut Brittle from The Candy Barn is recalled because peanuts and milk are missing from the contains statement. 665 packages across the firm's products are affected.

    Product
    Grandma's Old-Fashioned Peanut Brittle, The Candy Barn, 1113 Palm Ave Riverside, IA 52327, Net Wt: 4oz, flexible plastic bag
    Category
    Food
    Distribution
    1 state

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