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.

26076–26100 of 50450

  • HighFDA (Drugs)·D-1125-2019·2019-04-24

    InvaGen Recalls Testosterone Cypionate Injection Due to Particulate Matter

    InvaGen Pharmaceuticals is recalling Testosterone Cypionate Injection vials due to the presence of particulate matter. The affected lots were distributed nationwide in the U.S.A.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2019·2019-04-24

    Medrobotics Flex Robotic System Obturators Recalled for Weld Failure Risk

    Medrobotics is recalling 35 Flex Robotic System obturators because a weld may break, causing the rod to separate from the cone.

    Product
    Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1146-2019·2019-04-24

    Roche Lactate Gen.2 Recalled Due to Endogenous Interference Claims

    Roche Diagnostics is recalling Lactate Gen.2 reagents because new endogenous interference claims may affect test accuracy on specific analyzers.

    Product
    Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2019·2019-04-24

    Bioventus Recalls Bioactive Bone Graft Putty Due to Sterility Risk

    Bioventus is recalling 10,793 units of Bioactive Bone Graft Putty because sterile pouches may puncture during transit, potentially introducing non-sterile devices and causing patient infection.

    Product
    BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1184-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling 193 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with specific consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2019·2019-04-24

    GE Healthcare Recalls Innova IGS 630 X-Ray Systems for Imaging Loss

    GE Healthcare is recalling 49 Innova IGS 630 Interventional Fluoroscopic X-Ray Systems due to a potential loss of x-ray imaging function when changing the field of view while releasing the footswitch.

    Product
    Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling 13 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with compatible consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2019·2019-04-24

    GE Healthcare Recalls Innova IGS 6 X-Ray Systems Due to Imaging Loss

    GE Healthcare is recalling 22 Innova IGS 6 Interventional Fluoroscopic X-Ray Systems because they may lose x-ray imaging function during specific field of view changes.

    Product
    Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2019·2019-04-24

    Pintler Medical Recalls 24 Warming Pads Due to Malfunction

    Pintler Medical LLC is recalling 24 warming pads used in operating rooms because they malfunction. The affected units were distributed to facilities in Wisconsin.

    Product
    A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-1163-2019·2019-04-24

    Methylprednisolone Ophthalmic Drops Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Methylprednisolone 1% PF Ophthalmic drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2019·2019-04-24

    Wilson-Cook Recalls Acusnare Polypectomy Snares Due to Loop Retraction Issues

    Wilson-Cook Medical Inc. is recalling 34,456 Acusnare Polypectomy Snares because the snare loop may not completely retract or may misshape.

    Product
    Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2019·2019-04-24

    Olympus Diego Elite Console Recall for Unintended RF Energy Activation

    Gyrus ACMI is recalling Olympus Diego Elite Consoles because they may inadvertently activate the RF energy feature when used with specific blades.

    Product
    Olympus Diego Elite Console MDCONS 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2019·2019-04-24

    ProSun V3 42 Tanning Beds Recalled for Potential High UV Output

    ProSun International is recalling nine specific tanning beds due to quality control documentation discrepancies that could result in high UV output.

    Product
    ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2019·2019-04-24

    Abbott Alinity i Processing Module Recalled for Safety Interlock Defect

    Abbott is recalling Alinity i Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.

    Product
    Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V320000·2019-04-23

    Jeep Wrangler Recall for Roof Top Tent Cover Detachment Risk

    American Fastbacks is recalling 2018 Jeep Wranglers with roof top tents because the cover may crack and detach while driving, creating a road hazard.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19T004000·2019-04-22

    Toyo Recalls Proxes A27 Tires Due to Tread Detachment Risk

    Toyo is recalling specific Proxes A27 tires where a rubber compound error may cause tread to detach, increasing crash risk.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V309000·2019-04-18

    2019 Mercedes-Benz Sprinter Recalled for High-Beam Software Error

    Daimler Vans USA is recalling 2019 Mercedes-Benz Sprinter vans because a software error may prevent drivers from turning off high beams, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V316000·2019-04-18

    Nissan Recalls 2019 Altima Vehicles Due to Fuel Pump Lock Ring Defect

    Nissan is recalling 2019 Altima vehicles with front-wheel drive and 2.5-liter engines because a fuel pump lock ring may not be fully engaged, potentially causing a fuel leak and fire risk.

    Product
    NISSAN — NISSAN ALTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19108·2019-04-18

    Target Recalls Wooden Toy Vehicles Due to Choking Hazard

    Target is recalling Bullseye's Playground wooden toy vehicles because wheels can detach, posing a choking hazard to children.

    Product
    Bullseye's Playground wooden toy vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19739·2019-04-18

    RH Recalls Callum Canopy Beds Due to Falling Rail Injury Hazard

    RH is recalling Callum Canopy Beds because horizontal canopy rails can detach and fall. No injuries have been reported, but consumers should stop using the beds until repaired.

    Product
    Callum Canopy Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V313000·2019-04-18

    MobilityTrans Recalls Modified Ford and Ram Vans with Defective Foldaway Seats

    Mobility Transportation Services is recalling modified Ford and Ram vans because foldaway seats may not stay locked during a crash, increasing injury risk.

    Product
    FORD — FORD, RAM, MOBILITY SPECIALISTS E-350, E-250, PROMASTER, TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2019·2019-04-17

    Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Inter-Lumen Leak

    Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to a reported leak between the cardioplegia and pressure lumens.

    Product
    Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1240-2019·2019-04-17

    Lemon Berry Scone Recalled for Undeclared Milk Allergen

    Thomas Hammer Coffee Roasters is recalling Lemon Berry Scones because the label declared butter but failed to declare milk.

    Product
    Lemon Berry Scone
    Category
    Food
    Distribution
    2 states