The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

4601–4625 of 52939

  • HighFDA (Food)·F-0729-2025·2025-04-30

    Spermidine Dietary Supplement Recalled for Undeclared Wheat Allergen

    Supplement Manufacturing Partner Inc. is recalling Spermidine Maximum Strength 10 mg dietary supplement (Lot 12792402-44) because it contains undeclared wheat, a major allergen not listed on the label.

    Product
    Spermidine, Maximum Strength, 10 mg per serving, Support healthy Aging, Dietary Supplement, 120 Capsules, oral consumption, shelf life: 24 months, PETE/White/150cc Plastic bottle/lid, 120 count.Supplement Facts: Spermidine 3HCL 10mg*** Other Ingredients: Hydroxypropyl Methylcellu
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1655-2025·2025-04-30

    CELL-DYN Ruby hematology analyzer system expiration date validation

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers (model 08H67-13) because expired reagents can be used without proper notification when their expiration dates are scanned or entered into the system.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1657-2025·2025-04-30

    Globus Medical MAGEC 2 Rod recalled for incorrect outer diameter assembly

    Globus Medical is recalling MAGEC 2 Rod model MC2-5090S devices because certain units were assembled with a 5.5mm outer diameter rod instead of the required 5.0mm specification.

    Product
    MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2025·2025-04-30

    Rover Mobile X-ray System internal fastening mechanism failure potential

    Micro-X Ltd. is recalling Rover Mobile X-ray System units (models MXU-RV71, MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Affected units were distributed in New Jersey, Washington, and Puerto Rico.

    Product
    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring med
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1670-2025·2025-04-30

    Rover Mobile X-ray System internal fastening mechanism failure risk

    Micro-X Ltd. is recalling the Rover Mobile X-ray System (model MXU-RV35) due to a potential failure of the internal fastening mechanism within the generator. Five units distributed in New Jersey, Washington, and Puerto Rico are affected.

    Product
    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagno
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1663-2025·2025-04-30

    Skytron Freedom Monitor Mount Hardware Recall for Inadequate Thread Engagement

    The mounting hardware supplied with the Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount does not provide adequate thread engagement to support the weight of the frame and monitor, creating a risk of hardware failure and separation.

    Product
    Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1651-2025·2025-04-30

    Stryker Latitude EV Humeral Revision Stem Trial with Incorrect Marking

    A specific lot of Stryker Latitude Humeral Trial Stems has incorrect laser marking and color indicator, potentially resulting in implantation of the wrong device size and orientation.

    Product
    stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1581-2025·2025-04-30

    Zenition 70 Radiological System Wireless Foot Switch Recall

    Philips is recalling Zenition 70 radiological systems with wireless foot switches that may stick in the active position when released, potentially causing unintended radiation emission during medical procedures.

    Product
    Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0720-2025·2025-04-30

    Chicken Salad Recalled Due to Undeclared Milk Allergen

    Cromer Food Services is recalling chicken salad sandwiches because milk was not declared on the label. Consumers with milk allergies are at risk.

    Product
    CFS CROMER FOOD SERVICES, INC. Anderson, SC 29621 CHICKEN SALAD On White NET WT. 4.3 OZ CONTAINS: EGGS, WHEAT, SOY UPC 31166 & UPC 13172
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0737-2025·2025-04-30

    Cuban-Style Black Bean Soup recalled for potential wood contamination

    Request Foods Incorporated is recalling Cuban-Style Black Bean Soup due to potential contamination with wood. The product was distributed in Illinois and Michigan.

    Product
    Cuban-Style Black Bean Soup, 4 / 4lb pouches, Net Wt. 16lb
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1582-2025·2025-04-30

    Veradius Unity wireless foot switch pedal may emit unintended radiation

    Philips North America is recalling Veradius Unity foot switch pedals that may become stuck in the active position, causing unintended radiation emission during medical procedures.

    Product
    Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0733-2025·2025-04-30

    Magic Flame Hulled Sunflower Kernels Bakery Grade Recall

    JJ Nuts, LLC is recalling Magic Flame Hulled Sunflower Kernels due to glass fragments found in the finished product.

    Product
    MAGIC FLAME, HULLED SUNFLOWER KERNELS, BAKERY GRADE, 501b. Bag, Three ply Paper bags, 1100 Paper bags x 50 Ib. on 20 pallets. Store in dry warehouse, room temperature
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0734-2025·2025-04-30

    S Martinelli Apple Juice Recalled for Potential Patulin Contamination

    S Martinelli & Company is recalling approximately 7,234 cases of apple juice in 10 oz bottles due to potential contamination with patulin. Consumers who have purchased affected product should not consume it.

    Product
    Apple Juice; clear/translucent bulbous/round glass bottle with white metal screw top lid; (4 - 10 oz bottles per pack; 6 packs per case)
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-1583-2025·2025-04-30

    Zenition 70 Medical Device Recall: Unintended Radiation Exposure Risk

    Philips is recalling Zenition 70 systems with Vascular Extension option and Wireless Foot Switch due to potential for unintended radiation exposure in healthcare facilities.

    Product
    Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1660-2025·2025-04-30

    Philips Brilliance CT Big Bore X-Ray System Gantry Motion Collision Hazard

    Philips is recalling Brilliance CT Big Bore computed tomography systems due to unintended motion in the interventional control that may cause the gantry or table to collide with operators or patients.

    Product
    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2025·2025-04-30

    VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System C-Ring Break

    Maquet Cardiovascular is recalling the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System due to a ceramic C-Ring component that may break during use. At least 12 user complaints were reported as of March 3, 2025.

    Product
    The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens washer tube, and Harvesting Tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1650-2025·2025-04-30

    InPen Smart Insulin Pen Recall Due to Incorrect Assembly

    Medtronic MiniMed is recalling InPen smart insulin pens that may have been incorrectly assembled, potentially causing the insulin cartridge to not fit or the cartridge holder to be difficult to remove. Users without backup insulin could experience temporary hyperglycemia.

    Product
    InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1639-2025·2025-04-30

    BD PYXIS MEDBANK Automated Dispensing Cabinet Software Defect

    CareFusion's BD PYXIS MEDBANK and MEDFLEX automated dispensing cabinets may experience a software issue during bin restocking that doubles bin quantities, potentially delaying access to medications and supplies.

    Product
    BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2025·2025-04-30

    CELL-DYN Ruby hematology analyzer expiration date software defect

    Abbott Laboratories is recalling CELL-DYN Ruby hematology analyzers because a software defect allows expired reagents to be used without user notification. The system may incorrectly update expiration dates to current or future dates, contrary to the operator's manual.

    Product
    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0732-2025·2025-04-30

    MO-CHA Premium Non-Dairy Creamer Recalled for Undeclared Milk Allergen

    MO-CHA brand Premium Non-Dairy Creamer is recalled because the label does not declare milk as an allergen, despite milk being present in the product. Consumers with milk allergies are at risk of adverse reaction.

    Product
    MO-CHA brand Premium Non-Dairy Creamer; INGREDIENTS Glucose syrup, Refined vegetable oil, Whey powder, Sugar, Casein, Emulsifier (471, 481i), Stabilizer(340ii, 452i), Anti-caking agent(551), Food flavor; Shelf Life: 24 months; Net Weight (NET WT): 2.2 lbs (1kg); IMPORTED BY Momo
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·25E031000·2025-04-29

    Dainese Recalls AGV DOT Tourmodular Helmets Due to Chin Guard Defect

    Dainese is recalling AGV DOT Tourmodular helmets because the chin guard plate may break, allowing the helmet to loosen or detach during a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V280000·2025-04-25

    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, failing FMVSS 111.

    Product
    POLESTAR — POLESTAR POLESTAR 2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25E028000·2025-04-25

    Carrier Recalls Aspen Auxiliary Power Units Due to Fire Risk

    Carrier is recalling specific Aspen Auxiliary Power Units because corrosion on the positive terminal block may cause a short circuit and increase the risk of a fire.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V277000·2025-04-25

    Forest River Recalls 2025 Stealth and XLR Fifth Wheels for Wiring Defect

    Forest River is recalling 2025 Stealth and XLR fifth wheel travel trailers because a front exterior lamp wire lacks proper circuit protection, increasing fire risk.

    Product
    FOREST RIVER — FOREST RIVER STEALTH, XLR TOYHAULER 5TH WHEEL
    Category
    Vehicle
    Distribution
    Distributed nationwide