The Recall Desk

Archive

February 2025 recalls

506 recalls were announced in February 2025.

What the numbers show

Critical
7
Severe
122
High
357
Moderate
20

Of the 506 recalls this month scored against our rubric, 1% are Critical, 24% are Severe.

1–100 of 506

  • SevereNHTSA·25V135000·2025-02-28

    Mercedes Sprinter parking brake bracket welds can fail causing rollaway

    Daimler Vans is recalling certain 2024 Mercedes-Benz Sprinter vehicles because the parking brake cable bracket welds may fail and disengage the parking brake, failing FMVSS 105.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 2500, SPRINTER 1500, SPRINTER 4500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V126000·2025-02-28

    Ford EcoSport front half shafts can disconnect from the transmission

    Ford is recalling certain 2021-2022 EcoSport vehicles because the front axle half shafts may disconnect from the transmission, causing a loss of drive power and a possible rollaway.

    Product
    FORD — FORD ECOSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V127000·2025-02-28

    Ford Maverick control modules may miss a low 12-volt battery

    Ford is recalling certain 2022 Maverick vehicles previously repaired under 24V-590, because the body and powertrain control modules may fail to detect a change in 12-volt battery state of charge.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V130000·2025-02-28

    Ford Recalls 2021-2022 Mustang Mach-E for Battery Contactor Overheating Risk

    Ford is recalling 2021-2022 Mustang Mach-E vehicles previously repaired under recall 22V-412 because high voltage battery contactors may overheat, potentially causing loss of drive power and increasing crash risk.

    Product
    FORD — FORD MUSTANG MACH E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V125000·2025-02-28

    Audi Q4 e-tron on-board charger failure can cut drive power

    Volkswagen is recalling certain 2024-2025 Audi Q4 e-Tron and 2024 ID.4 vehicles because the on-board charger may fail and stop charging the 12-volt battery, causing a loss of drive power.

    Product
    AUDI — AUDI, VOLKSWAGEN Q4 E-TRON, Q4 SPORTBACK E-TRON, ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V129000·2025-02-28

    Mercedes-Benz Recalls Hybrid AMG Models Due to Software Error

    Mercedes-Benz is recalling 2,943 hybrid AMG vehicles because a software error may cause the high-voltage starter alternator control unit to fail, resulting in a loss of drive power.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT63 S E, AMG GLC63 S E 4MATIC+ COUPE, AMG S 63 E, AMG GT 63 S E COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V133000·2025-02-28

    Ford hybrids can shift into neutral unexpectedly losing drive power

    Ford is recalling certain 2022-2024 Maverick, 2022 Escape and 2021-2022 Lincoln Corsair vehicles previously repaired under 24V-330, because hybrid powertrain software may shift the vehicle into neutral unexpectedly.

    Product
    FORD — FORD, LINCOLN MAVERICK, ESCAPE, CORSAIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V131000·2025-02-28

    Ford Recalls 2022-2024 F-150 Lightning Vehicles Due to Battery Fire Risk

    Ford is recalling 2022-2024 F-150 Lightning electric trucks because a manufacturing defect in the high-voltage battery cells may cause an internal short circuit, increasing the risk of a fire.

    Product
    FORD — FORD F-150 LIGHTNING BEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V132000·2025-02-28

    Ford trucks may fail to apply electric trailer brakes

    Ford is recalling certain 2021-2022 F-150, 2022 Maverick, Expedition, Navigator and Super Duty vehicles previously repaired under 22V-193, because a towed trailer's electric brakes may not apply.

    Product
    FORD — FORD, LINCOLN F-150, MAVERICK, EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V134000·2025-02-28

    Ford Super Duty rearview image may not show with hitch assist

    Ford is recalling certain 2023 F-Super Duty F-250, F-350 and F-450 vehicles previously repaired under 23V-573, because the default rearview camera image may not display when using Pro Trailer Hitch Assist.

    Product
    FORD — FORD F-350 SD, F-250 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V124000·2025-02-28

    Ford Maverick brake lights can illuminate without the driver braking

    Ford is recalling certain 2022 Maverick vehicles previously repaired under 24V-730, because the ABS module may illuminate the brake lights when the driver is not braking. This fails FMVSS 108.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V123000·2025-02-28

    Ford Maverick Hybrid instrument cluster may not illuminate warning lights

    Ford is recalling certain 2022-2023 Maverick Hybrid vehicles previously repaired under 24V-140, because the instrument panel cluster may not properly illuminate warning lights or gauges.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V136000·2025-02-28

    Big Tex Recalls 2025 Trailers Due to Undersized Winch Hardware

    Big Tex Trailer Manufacturing is recalling 2025 14RB, 14RD, 16RB, and 16RD trailers because undersized winch hardware may allow the winch to detach, creating a road hazard.

    Product
    BIG TEX — BIG TEX 14RB, 16RD, 16RB, 14RD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·25157·2025-02-27

    Gas boilers recalled for carbon monoxide poisoning risk; two deaths reported

    Triangle Tube is recalling approximately 60,000 Prestige and Aerco Esteem gas boilers due to carbon monoxide release hazard. Two deaths and 25 CO leak incidents have been reported.

    Product
    Prestige Solo, Prestige Excellence, and Aerco Esteem condensing gas boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25165·2025-02-27

    TRUBLUE auto belay systems recalled due to fall hazard risk

    Head Rush Technologies is recalling approximately 410 TRUBLUE auto belay devices sold online from May 2023 through December 2024 because they can fail to retract, posing a fall hazard. One incident resulted in a fractured leg.

    Product
    TRUBLUE iQ and TRUBLUE iQ+ Auto Belays
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V121000·2025-02-27

    Motorhome exhaust tips can detach letting fumes into the cabin

    REV Recreation Group is recalling certain 2022-2025 Fleetwood and Holiday Rambler motorhomes because the engine exhaust tip may detach, allowing exhaust fumes to enter the cabin.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER FLAIR, VACATIONER, FORTIS, BOUNDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25159·2025-02-27

    Goal Zero Solar Series Combiner Cables Recalled for Fire Hazard

    Goal Zero LLC is recalling about 530 Solar Series Combiner Cables that can malfunction with Nomad-series solar panels and pose a fire hazard. The company has received two reports of fires involving property damage.

    Product
    Goal Zero Solar Series Combiner Cables for Solar Panels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25704·2025-02-27

    Wayfair Recalls Style Life Eleven Baby Loungers for Suffocation and Fall Hazards

    Wayfair recalls about 1,555 Style Life Eleven baby loungers due to suffocation, fall, and entrapment hazards that violate federal infant sleep safety standards. Stop using them and contact Wayfair for a refund.

    Product
    Style Life Eleven Baby Loungers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V120000·2025-02-27

    Volkswagen and Audi electric vehicles may not display gear position indicator

    Volkswagen is recalling certain 2021-2023 ID.4 and 2022-2023 Audi Q4 e-Tron vehicles because the instrument panel may not properly display the transmission gear lever indicator, failing FMVSS 102.

    Product
    AUDI — AUDI, VOLKSWAGEN Q4 SPORTBACK E-TRON, ID.4, Q4 E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25161·2025-02-27

    P.J. Salvage Children's Pajama Sets and Robes Recalled for Flammability Violation

    P.J. Salvage recalled approximately 9,400 children's pajama sets and robes sold at Nordstrom Rack because they violate federal flammability regulations, posing a risk of burn injuries to children. No injuries have been reported.

    Product
    P.J. Salvage Pajama Sets and Robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25156·2025-02-27

    Canyon Speedmax CF Triathlon Bicycles Recalled for Fork Cracking Hazard

    Canyon Bicycles USA recalls about 1,400 Speedmax CF triathlon bicycles due to fork steerer tubes that can crack or break, creating a fall hazard. The company is offering free repairs at authorized service centers.

    Product
    Canyon Speedmax CF Triathlon Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25164·2025-02-27

    ARVA Neo BT Pro Avalanche Transceivers Recalled for Battery Drain Risk

    ARVA Neo BT Pro Avalanche Transceivers with defective fuses may lose battery power during use, preventing emergency transmission in avalanche rescues. About 1,067 units sold between September 2022 and January 2025 are affected.

    Product
    ARVA Neo BT Pro Avalanche Transceivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25158·2025-02-27

    Forever 21 Children's Pajamas Recalled for Flammability Violations

    Forever 21 recalled about 24,700 children's pajamas sold nationwide from November 2023 through November 2024 due to flammability violations. The pajamas don't meet federal safety standards for children's sleepwear and pose a burn injury risk.

    Product
    Forever 21 Children's Pajamas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V122000·2025-02-27

    Orange EV Recalls HUSK-E Trucks Due to Incorrect Weight Rating Placard

    Orange EV is recalling 2023-2024 HUSK-E XP terminal trucks because the rear weight rating placard is incorrect and tires may be inadequate, increasing crash risk.

    Product
    ORANGE EV — ORANGE EV HUSK-E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25166·2025-02-27

    Costway recalls Babyjoy high chairs due to suffocation and entrapment hazards

    Costway is recalling about 4,400 Babyjoy high chairs due to suffocation and entrapment hazards. The chairs were designed or marketed for infant sleep with excessive incline and have unsafe gaps where children can become trapped.

    Product
    Babyjoy High Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25162·2025-02-27

    Kichler Ellerbeck Wall Sconces Recalled Due to Electric Shock Risk

    Kichler Lighting has recalled approximately 2,760 Ellerbeck Wall Sconces because electrical wires can become damaged at the adjustable joints, creating a risk of electric shock. No injuries have been reported.

    Product
    Ellerbeck Wall Sconces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1152-2025·2025-02-26

    Philips Allura Xper Patient Table Mattress Defect Fall Risk

    Philips is recalling the Allura Xper FD10C patient examination table due to a mattress defect that may allow patients to fall from the table. The device was distributed worldwide.

    Product
    Allura Xper FD10C; Catalog number: 722001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1144-2025·2025-02-26

    Allura Xper FD20 Fluoroscopy Table Mattress Issue Causes Fall Risk

    Philips recalls Allura Xper FD20 fluoroscopy patient tables due to a mattress issue that may cause patients to fall during procedures.

    Product
    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1070-2025·2025-02-26

    Vascular Tack Endovascular System recalled for deployment and migration risks

    Spectranetics' Intact Vascular Tack Endovascular System may fail to deploy properly or migrate in blood vessels, potentially causing ischemia and requiring additional intervention.

    Product
    Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 15613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1146-2025·2025-02-26

    Surgical Operating Table Recalled Due to Patient Fall Risk

    Philips Medical Systems is recalling the Allura Xper FD20 Biplane OR Table due to a mattress defect that could cause patients to fall during surgery. 3 units are affected globally.

    Product
    Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1142-2025·2025-02-26

    Medical imaging device patient table mattress may cause patient falls

    Philips is recalling Allura Xper FD10 imaging devices because the patient table mattress may not securely hold patients during procedures, creating a fall hazard. The recall affects 2,274 units worldwide, including 459 in the U.S.

    Product
    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1160-2025·2025-02-26

    Azurion 7 M20 Patient Tables Recalled for Patient Fall Risk

    Philips recalls Azurion 7 M20 patient tables due to a mattress defect that could cause patients to fall. Approximately 1,480 units in the US and 2,741 units overseas are affected.

    Product
    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1145-2025·2025-02-26

    Philips Allura Xper FD20 Biplane Patient Fall Risk Recall

    Philips Allura Xper FD20 Biplane x-ray tables are being recalled due to a mattress defect that could cause patients to fall. The recall affects 479 units distributed worldwide.

    Product
    Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0567-2025·2025-02-26

    ZAARAH HERBALS Shatavari Powder recalled for elevated lead contamination

    ZAARAH HERBALS brand Shatavari Powder is recalled due to elevated lead contamination at 6.50 mg/kg. The affected batch was distributed in NY, NJ, CT, and CA.

    Product
    ZAARAH HERBALS brand SHATAVARI POWDER; 100% ASPARAGUS RACEMOSUS; (Supports Female Reproductive System); Supreme Fine Powder 100g (3.5 oz); Manufactured by FALCON SYSTEM OF AYUREVEDIC PRODUCTS Auto Nagar, Belgaum, Karnataka 590015 (INDIA); Manufactured for: ZAARAH HERBALS, USA; pa
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1155-2025·2025-02-26

    Philips Azurion 5 M12 Patient Table Recalled for Fall Risk

    Philips Medical Systems is recalling Azurion 5 M12 imaging tables due to a mattress defect that could allow patients to fall from the table.

    Product
    Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1149-2025·2025-02-26

    Philips recalls Allura patient table mattress due to fall hazard

    Philips is recalling Allura Xper patient table mattresses because a defect could cause patients to fall. The recall involves 302 units distributed globally.

    Product
    Allura Xper FD20/15; Catalog numbers: 722058
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1158-2025·2025-02-26

    Philips Azurion 7 B20 imaging system patient fall hazard from table mattress

    Philips Azurion 7 B20 imaging systems are recalled because the patient table mattress may allow patients to fall. This FDA Class I recall affects 1,314 units distributed worldwide.

    Product
    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1148-2025·2025-02-26

    Philips Allura Xper FD20/10 Imaging System Patient Table Mattress Fall Risk

    Philips is recalling the Allura Xper FD20/10 imaging system due to a defect in the patient table mattress that could allow patients to fall during procedures. The Class I recall affects 87 units distributed globally, including 22 in the US.

    Product
    Allura Xper FD20/10; Catalog numbers: 722029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1153-2025·2025-02-26

    Philips Azurion 3 M12 Medical Table Recalled for Patient Fall Risk

    Philips is recalling Azurion 3 M12 patient tables due to possibility of patient falling from the table related to the mattress. The recall affects 263 units distributed in the US and internationally.

    Product
    Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0569-2025·2025-02-26

    Jack & the Green Sprouts Alfalfa Sprouts Recalled for Listeria Contamination Risk

    Jack & the Green Sprouts Alfalfa Sprouts are being recalled due to potential Listeria monocytogenes contamination. Affected products are distributed in Iowa, Minnesota, and Wisconsin.

    Product
    Jack & the Green Sprouts Alfalfa Sprouts. Net Weight 5 oz. (152g). UPC 7 63247-19891 5. Keep Refrigerated. Product of USA. River Falls, WI 54022.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0230-2025·2025-02-26

    Phenylephrine HCl Injection Recall Due to Particulate Matter

    Provepharm Inc. is recalling Phenylephrine HCl Injection vials (Lot 24020027) due to the presence of particulate matter. The affected medication was distributed nationwide.

    Product
    Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1157-2025·2025-02-26

    Philips Azurion 7 B12 examination tables recalled due to patient fall risk

    Philips Medical Systems is recalling Azurion 7 B12 examination tables due to a mattress-related patient fall risk. The recall affects 602 total units, including 94 in the US and 508 internationally.

    Product
    Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1150-2025·2025-02-26

    Philips Allura Xper FD20/20 Imaging Table Mattress Recall

    Philips is recalling 114 units of the Allura Xper FD20/20 imaging table due to mattress defects that could cause patients to fall. 33 units are in the US; 81 are internationally distributed.

    Product
    Allura Xper FD20/20; Catalog numbers: 722038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0245-2025·2025-02-26

    Fentanyl Transdermal Patches Recalled for Defective Delivery System

    Alvogen has recalled Fentanyl Transdermal System patches (25 mcg/h) nationwide due to a manufacturing defect where patches may be stacked together in a single pouch. Patients using affected lots should contact their healthcare provider.

    Product
    FENTANYL SYSTEM — FENTANYL SYSTEM (FENTANYL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1159-2025·2025-02-26

    Azurion 7 M12 Patient Tables: Fall Risk from Defective Mattress

    Philips Azurion 7 M12 patient tables are recalled due to a mattress defect that could cause patients to fall. Approximately 1,837 units are affected globally.

    Product
    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1147-2025·2025-02-26

    Operating room table recalled due to mattress-related patient fall risk

    Philips Allura Xper FD20 OR Table units (catalog numbers 722023, 722035) are recalled due to a mattress defect that could cause patients to fall during procedures.

    Product
    Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1151-2025·2025-02-26

    Philips Allura CV20 Patient Table: Fall Risk from Mattress Defect

    Philips is recalling the Allura CV20 patient table due to a mattress defect that could allow patients to fall. The recall affects 111 units distributed worldwide.

    Product
    Allura CV20; Catalog numbers: 722031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0564-2025·2025-02-26

    Paras Premium Golden Raisins Recalled for Undeclared Sulfites

    Paras Premium Golden Raisins are being recalled due to undeclared sulfites (56.8mg per serving), which can cause serious allergic reactions in sensitive individuals.

    Product
    Paras Premium Golden Raisins; 7 oz and 14 oz; INGREDIENTS: RAISINS; ALLERGEN STATEMENT: Processed in a gluten-free and peanut-free plant; UPC: 818051014811 and 818051014828
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1156-2025·2025-02-26

    Philips Azurion 5 M20 tables recalled due to patient fall risk

    Philips is recalling Azurion 5 M20 imaging tables worldwide due to a mattress defect that could cause patients to fall from the table. This FDA Class I recall involves 632 units.

    Product
    Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1154-2025·2025-02-26

    Philips Azurion 3 M15 Patient Tables Recalled for Patient Fall Risk

    Philips recalls Azurion 3 M15 imaging tables due to mattress defects that could cause patients to fall from the examination table.

    Product
    Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1143-2025·2025-02-26

    Philips Allura Xper Fluoroscopy Device Patient Table Mattress Fall Risk

    Philips Medical is recalling certain Allura Xper FD10/10 fluoroscopy systems because the patient table mattress could cause patients to fall during procedures. The recall affects devices worldwide.

    Product
    Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1161-2025·2025-02-26

    Philips Allura Centron patient table mattress defect poses fall risk

    Philips is recalling Allura Centron patient examination tables due to a mattress defect that poses a fall risk. Eighty units have been distributed internationally.

    Product
    Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0565-2025·2025-02-26

    THREE RIVERS Tutti-Frutti Candy Recalled for Undeclared Yellow Dyes

    THREE RIVERS brand Tutti-Frutti candy contains undeclared FD&C Yellow 5 and Yellow 6 dyes that were not listed on the label. Consumers allergic or sensitive to these colorants should not consume the product.

    Product
    THREE RIVERS brand TUTTI-FRUTTI; INGREDIENTS Papaya Cubes, Sugar, Citric Acid (E-330), Potassium Sorbate (E-202), FD&C Red #40, FD&C Blue #1, Curcumine #E-100, Annatto #E-160b; Imported & Distributed by SHATA TRADERS; Net Weight - 250 g, 8.81 OZ, 0.55 LBS; UPC: 7 93283 75373 1
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0235-2025·2025-02-26

    Atomoxetine Capsules Recalled Due to Excess N-Nitroso Impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. The nationwide recall affects 80,160 bottles.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2025·2025-02-26

    RayStation Radiation Therapy Planning Software Recall for Density Calculation Inconsistency

    RayStation radiation therapy planning software contains an inconsistency in how it calculates density uncertainty for proton and light ion treatments. This affects versions 4.5 through 2024B and could impact treatment plan accuracy.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2025·2025-02-26

    Augustine HotDog return electrode connector cables electrode contact error recall

    Augustine Temperature Management is recalling HotDog return electrode accessory connector cables (Model A136) used with warming blankets and mattresses. Users reported error M-0B-125 indicating improper neutral electrode contact.

    Product
    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0237-2025·2025-02-26

    Atomoxetine Capsules Nationwide Recall for N-Nitroso Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling 39,168 bottles of Atomoxetine 100 mg capsules nationwide due to manufacturing deviations that resulted in N-Nitroso impurity exceeding FDA recommended limits. No illnesses have been reported.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2025·2025-02-26

    Medline Intubation Kits Recalled Due to Reduced Skin Barrier Wear

    Medline is recalling 70 intubation convenience kits distributed in California and New York due to skin barrier components with reduced wear time that may lose effectiveness sooner than intended.

    Product
    Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1198-2025·2025-02-26

    Patient Warming Mattress Connector Cable Intermittent Connection Defect

    Augustine Temperature Management is recalling Hot Dog Patient Warming Mattresses due to connector cable defects that may cause intermittent electrical connection after extended use, potentially affecting the device's heating function.

    Product
    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0225-2025·2025-02-26

    FDA Recalls Compounded Fentanyl Citrate IV Bags Due to Sterility Concerns

    Fagron Compounding Services is recalling 1,330 units of fentanyl Citrate IV bags (Lot C274-000040409) distributed in Pennsylvania due to lack of sterility assurance. The product may pose a contamination risk if administered.

    Product
    fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0231-2025·2025-02-26

    Atomoxetine Capsules Recalled for Elevated Nitrosamine Impurity

    Glenmark Pharmaceuticals is recalling 70,032 bottles of Atomoxetine Capsules nationwide due to N-Nitroso impurity exceeding FDA recommended limits.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0233-2025·2025-02-26

    Prescription Atomoxetine capsules recalled for N-Nitroso impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine 25 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 175,920 bottles are affected.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1186-2025·2025-02-26

    RayStation radiation therapy planning software density uncertainty calculation inconsistency

    RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in density uncertainty handling when HU-to-mass density CT calibration curves are used. No illnesses or injuries have been reported.

    Product
    Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1189-2025·2025-02-26

    Radiation Therapy Planning System Density Calculation Inconsistency in RayStation

    RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in how density uncertainty is handled in dose calculation functions for proton and light ion therapy plans.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0243-2025·2025-02-26

    Atomoxetine Capsules Recalled Due to N-Nitroso Impurity Contamination

    Glenmark Pharmaceuticals is recalling approximately 58,416 bottles of Atomoxetine 80 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. This is a Class II recall.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2025·2025-02-26

    remel Blood Agar EMB Agar Biplate Recalled for Listeria Contamination

    Remel's blood agar culture media plates (lot 213971) may contain Listeria monocytogenes contamination visible on the blood side. The affected product was distributed nationwide; users should discontinue use immediately.

    Product
    remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2025·2025-02-26

    Lorazepam tablets recalled due to failed potency and impurity specifications

    The Harvard Drug Group LLC is recalling Lorazepam 2mg tablets due to out-of-specification results in potency and impurity testing. Affected products were distributed nationwide.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0234-2025·2025-02-26

    Atomoxetine capsules recalled due to elevated N-nitroso impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine 40 mg capsules nationwide due to manufacturing deviations. Some lots contain N-nitroso Atomoxetine impurity above FDA-recommended limits.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2025·2025-02-26

    Dexcom G6 Glucose Monitoring System Receiver May Fail to Deliver Critical Alarms

    The Dexcom G6 receiver may rarely fail to deliver or delay glucose alarms due to a software error, potentially missing dangerous blood sugar events. No illnesses have been reported.

    Product
    Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2025·2025-02-26

    LIFEPAK 15 Monitor Software Error Disables Sensor Monitoring

    Physio-Control is recalling 622 LIFEPAK 15 V4 monitors due to a software error that prevents monitoring of carboxyhemoglobin and methemoglobin saturation levels in affected sensors.

    Product
    LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0227-2025·2025-02-26

    Lorazepam Tablets Recalled for Failed Impurity and Potency Specifications

    The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets due to out-of-specification results for impurities and sub-potency discovered during routine stability testing. The affected product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2025·2025-02-26

    Atomoxetine Capsules Recalled for N-Nitroso Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to N-Nitroso impurity levels exceeding FDA recommended limits. The recall affects 56,208 bottles nationwide with specific lot numbers.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2025·2025-02-26

    RayStation Radiation Therapy Software Recalled for Dose Calculation Inconsistency

    RayStation radiation therapy planning software is being recalled due to inconsistent handling of density uncertainty in dose calculations for proton and light ion treatment plans. The software defect may affect the accuracy of calculated radiation doses.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0236-2025·2025-02-26

    Atomoxetine 80 mg Capsules Recalled for N-Nitroso Impurity Contamination

    Glenmark Pharmaceuticals is recalling 87,600 bottles of Atomoxetine 80 mg capsules nationwide due to N-Nitroso Atomoxetine impurity detected above FDA-recommended limits. Consult your healthcare provider if affected.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0566-2025·2025-02-26

    Feel Good Foods Three Cheese Mac & Cheese Bites recalled due to metal pieces

    Feel Good Foods Three Cheese Mac & Cheese Bites are being recalled nationwide due to the presence of metal pieces in the frozen product. Metal fragments pose a potential choking or injury hazard.

    Product
    Feel Good Foods; Three Cheese Mac & Cheese Bites; NET WT 8oz (224g); packaged in yellow carton; 9 units per case; Frozen; UPC: 89903900280-8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2025·2025-02-26

    Medline Respiratory Intubation Kits Recalled for Reduced Skin Barrier Wear

    Medline is recalling respiratory intubation convenience kits because skin barrier components wear out faster than designed. Affected kits may require more frequent replacement than expected.

    Product
    Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0568-2025·2025-02-26

    AAHU BARAH brand Soft Plum recalled for undeclared sulfites

    AAHU BARAH brand Soft Plum is being recalled due to undeclared sulfites in the product. Consumers sensitive to sulfites should not consume this product and should return it to the point of purchase.

    Product
    AAHU BARAH brand SOFT PLUM; NET WT. 0.5 LB; Import By: AAHU BARAH USA, INC.; Soft Plum Aloo Bukahara 1/2 LB; *May Contain Sulfites As preservatives; UPC 882475049186; packaged in clear plastic bags.
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1172-2025·2025-02-26

    Augustine HotDog Return Electrode connector cables trigger contact error

    Augustine Surgical Inc. is recalling HotDog Return Electrode connector cables (Model A138) that display a 'Check Neutral Electrode Contact' error message. The recall affects 7 units distributed to Alabama, Texas, and Nevada.

    Product
    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1199-2025·2025-02-26

    Patient Warming Mattress Recalled for Cable Connection Defect

    Augustine Temperature Management recalls 3 Hot Dog patient warming mattresses (US530) due to cable connector deflection that may cause intermittent connection failure, potentially occurring after one year of use.

    Product
    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2025·2025-02-26

    Medline Medical Convenience Kits Recalled for Catheter Sterility Issue

    Medline is recalling medical convenience kits assembled with Coloplast Foley and prostatic catheters that were recalled due to a potential sterility issue detected during testing.

    Product
    Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1181-2025·2025-02-26

    AnchorFast Guard Endotracheal Tube Fasteners Recalled Due to Tube Migration Risk

    Hollister is recalling AnchorFast Guard endotracheal tube fasteners because decreased skin barrier wear time could cause tube migration. The recall affects multiple lot numbers distributed in the US and Canada.

    Product
    AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2025·2025-02-26

    Hot Dog Patient Warming Mattress Connector Cable Deflection Recall

    Augustine Temperature Management is recalling 4 units of the Hot Dog Patient Warming Mattress due to connector cable deflection that causes intermittent connection failures after approximately one year of use.

    Product
    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1185-2025·2025-02-26

    Radiation Therapy Planning Software Correction for Density Uncertainty in Dose Calculations

    RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations within dose planning functions affecting proton and light ion treatments in versions 4.5 through 2024B.

    Product
    Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2025·2025-02-26

    Medical Diagnostic Culture Media Recalled for Listeria Contamination

    Remel, Inc recalls blood agar culture media used in diagnostic laboratories for potential Listeria monocytogenes contamination. The affected lot was distributed nationwide.

    Product
    remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0240-2025·2025-02-26

    Prescription Drug Recall: Atomoxetine Capsules Due to Impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine 25mg capsules nationwide due to manufacturing deviations resulting in N-Nitroso Atomoxetine impurity above FDA limits. Consumers should contact their healthcare provider or pharmacist.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0570-2025·2025-02-26

    Bacon Flavored Popcorn Seasoning Recall Due to Undeclared Soy Allergen

    Wabash Valley Farms and Rural King bacon flavored popcorn seasoning products are being recalled because soy allergen is not declared on the label, posing a risk to consumers with soy allergies.

    Product
    Bacon flavored Popcorn Seasoning packaged under the following brands and sizes: 1. Wabash Valley Farms, Net Wt. 4.2 oz (119.1g), UPC 0 19669-00303 1. Dist. by: Wabash Valley Farms, Monon, IN 47959. Made in U.S.A. 2. Wabash Valley Farms, Net Wt. 1 oz. (28g), UPC 0 19669-
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0571-2025·2025-02-26

    Wegmans Organic Almonds Recalled for Incorrect Back Label Stating Cashews

    Wegmans Organic Almonds are being recalled due to an incorrect back label identifying the product as cashews instead of almonds. This mislabeling poses a risk for consumers with tree nut allergies.

    Product
    Wegmans, Organic Almonds Dry Roasted Salted, 12oz clear bag, 12 bags per case.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0226-2025·2025-02-26

    Lorazepam Tablets Recalled Due to Sub-Potency and Failed Stability Testing

    The Harvard Drug Group is recalling Lorazepam Tablets USP 0.5mg due to sub-potency and failed stability test results. Approximately 82,281 cartons are affected nationwide and in Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0244-2025·2025-02-26

    Atomoxetine Prescription Capsules Recalled for Impurity Above FDA Recommended Level

    Glenmark Pharmaceuticals is recalling 58,368 bottles of Atomoxetine Capsules 100 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. The recall affects bottles distributed nationwide.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2025·2025-02-26

    Irix-A Lumbar Fusion Implants Recalled for Incorrect Expiration Dates

    XTANT Medical Holdings is recalling Irix-A Lumbar Fusion System implants due to incorrect expiration date labeling on sterile spacers. Fourteen units were distributed in Arizona, California, Colorado, Louisiana, Ohio, Texas, West Virginia, and Australia.

    Product
    Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2025·2025-02-26

    Medical device recall: RayStation radiation therapy software dose calculation inconsistency

    RayStation radiation therapy treatment planning software contains an inconsistency in density uncertainty calculations that may affect dose accuracy for proton and light ion treatments. The issue affects systems using HU-to-mass density CT calibration curves from RayStation versions 4.5 through 2024B.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1192-2025·2025-02-26

    RayStation radiation therapy planning software density uncertainty computational defect

    RayStation treatment planning software versions 4.5 through 2024B may incorrectly handle density uncertainty in radiation dose calculations for proton and light ion therapy. An inconsistency in three key functions could affect treatment planning accuracy.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2025·2025-02-26

    3M V.A.C. VIA Negative Pressure Wound Therapy System Recalled for Leak Alarm Malfunctions

    KCI USA is recalling approximately 2,169 units of the 3M V.A.C. VIA negative pressure wound therapy system due to increased complaints about leak alarm malfunctions affecting certain units.

    Product
    3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0241-2025·2025-02-26

    Atomoxetine 40 mg Capsules Recalled for N-Nitroso Impurity Above Limits

    Glenmark Pharmaceuticals is recalling 233,040 bottles of Atomoxetine 40 mg capsules nationwide due to N-Nitroso impurity above FDA safety limits. Patients should check their medication bottles and contact their healthcare provider.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2025·2025-02-26

    RayStation radiation therapy planning software density uncertainty calculation inconsistency

    RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations affecting robust optimization and dose computation functions for proton and light ion treatment plans.

    Product
    Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1190-2025·2025-02-26

    RayStation radiation therapy software: incorrect density uncertainty calculations in dose planning

    RayStation radiation therapy planning software versions 4.5 through 2024B contains an inconsistency in density uncertainty calculations affecting proton and light ion dose computations. No illnesses reported.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0242-2025·2025-02-26

    Atomoxetine Capsules Recalled for Manufacturing Impurity Above Limits

    Glenmark Pharmaceuticals is recalling Atomoxetine Capsules, 60 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 53,952 bottles were distributed nationwide.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2025·2025-02-26

    RayStation radiation therapy software recall for density calculation inconsistency

    RayStation treatment planning software versions 4.5-2024B contain a calculation error in density uncertainty functions affecting proton and light ion treatment plans. The error could lead to incorrect dose calculations.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
    Category
    Medical Device
    Distribution
    Distributed nationwide

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