The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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1476–1500 of 27375

  • HighFDA (Devices)·Z-1093-2026·2026-01-21

    Cell wash solution recalled over fungal contamination of an affected lot

    Hologic is recalling 3,728 units of ThinPrep CytoLyt Solution over fungal contamination of the affected lot with Parengyodontium album.

    Product
    ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2026·2026-01-21

    Patient positioning systems recalled over stereotactic radiosurgery tolerance errors

    C-RAD Positioning is recalling 189 Catalyst and Catalyst+ systems because the system may indicate a patient as correctly positioned at the isocenter when it is outside tolerance.

    Product
    Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1000-2026·2026-01-14

    Organ recovery packs recalled as not suitable for organ transplant

    AVID Medical is recalling 132 Halyard Organ Recovery OR Packs, kit code LLOG1000-15, because the devices are not suitable for organ transplant.

    Product
    Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1002-2026·2026-01-14

    Mini Plus surgical kits recalled as not suitable for organ transplant

    AVID Medical is recalling 380 Halyard Mini Plus Kit South units because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.

    Product
    Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1001-2026·2026-01-14

    Organ recovery surgical packs recalled as not suitable for organ transplant

    AVID Medical is recalling 52 Halyard Organ Recovery OR Packs because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.

    Product
    Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2026·2026-01-14

    Head fixation devices recalled because a torque screw may crack or separate

    IMRIS Imaging is recalling 122 HFD100 Head Fixation Devices because a torque screw may crack or separate, which could lead to inadequate head stabilization and risk of patient injury.

    Product
    Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1032-2026·2026-01-14

    Emergency call stations recalled over missing low battery alerts

    Securitas Healthcare is recalling 1,898 Arial 900 MHz Call Stations, model CSK200-900MR, because a firmware issue may prevent a low battery alert being transmitted before the battery fails.

    Product
    Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2026·2026-01-14

    Thyroid receptor immunoassay recalled over variable results across instrument platforms

    Roche Diagnostics is recalling 1,300 Elecsys Anti-TSHR cassettes because results vary by instrument platform and calibrator lots vary, which may lead to incorrect diagnosis or treatment.

    Product
    The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocompl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2026·2026-01-14

    Telemetry monitors recalled over a failure to reconnect between access points

    Philips North America is recalling 13,470 Smart-hopping 2.0 AP 1.4 GHz patient monitors because the MX40 could not reconnect to the PIC iX when signal strength changed quickly.

    Product
    Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2026·2026-01-14

    C. difficile assay recalled over declining performance and false negative results

    Meridian Bioscience is recalling 211 units of the Revogene C. difficile assay because affected lots show a decline in performance over time, which may lead to false-negative results.

    Product
    Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2026·2026-01-14

    Oxygen masks recalled after complaints of tubing disconnecting during use

    Medline is recalling 1,611,081 Hudson RCI medium concentration oxygen masks after multiple complaints of tubing disconnecting, which may lead to shortness of breath and hypoxia.

    Product
    Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRAT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2026·2026-01-14

    Arial call stations recalled over a firmware issue affecting battery alerts

    Securitas Healthcare is recalling 5,627 Arial 900 MHz Call Stations, model CSK200-900, because a firmware issue may prevent a low battery alert being transmitted before the battery fails.

    Product
    Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2026·2026-01-14

    Patient monitors recalled over unvalidated intracranial and bladder pressure measurements

    Remote Diagnostic Technologies is recalling 7,129 Philips Tempus Pro Patient Monitors because intracranial and bladder pressure measurements have not been tested or validated for accuracy.

    Product
    Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2026·2026-01-14

    Medication dispensing servers recalled over delayed updates from enterprise systems

    CareFusion 303 is recalling 2,079 BD Pyxis ES Enterprise Server systems over a software issue that may result in equipment not receiving timely updates of patient or medication information.

    Product
    BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2026·2026-01-07

    Ultrasound probe covers recalled over defects that may cause contamination during use

    Sheathing Technologies is recalling 12 units of Sheathes3D vaginal and rectal ultrasound probe covers because product defects may result in contamination during use, posing an infection risk.

    Product
    Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0934-2026·2025-12-31

    Vapor 3000 anesthetic vaporizers recalled over an out of specification component

    Draeger is recalling 188 Vapor 3000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.

    Product
    Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0933-2026·2025-12-31

    Vapor 2000 anesthetic vaporizers recalled over an out of specification component

    Draeger is recalling 431 Vapor 2000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.

    Product
    Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0939-2026·2025-12-31

    Ophthalmic surgical packs recalled over incomplete seals affecting sterility

    Alcon Research is recalling 151 Custom Pak ophthalmic procedure packs because the packs may have incomplete seals affecting sterility. The FDA has classified the action as Class I.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience k
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2026·2025-12-31

    Dialysis concentrate 100125 recalled because safety and efficacy cannot be assured

    Diasol is recalling 7,200 gallons of liquid concentrate for bicarbonate dialysis, product 100125-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2026·2025-12-31

    Digital radiography systems recalled over exceeding the maximum air kerma rate

    AGFA Healthcare is recalling 35 DR 800 X-ray systems because it is possible to exceed the maximum allowed air kerma rate of 88mGy/min for pulsed fluoroscopy exams.

    Product
    Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2026·2025-12-31

    Dialysis concentrate 100325 recalled because safety and efficacy cannot be assured

    Diasol is recalling 74,400 gallons of liquid concentrate for bicarbonate dialysis, product 100325-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.

    Product
    Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0965-2026·2025-12-31

    Infusion drug library software recalled over a failing change review option

    ICU Medical is recalling LifeShield Drug Library Management software because the Change Summary review option stops working for migrated libraries, which may lead to dosing or setup errors.

    Product
    LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2026·2025-12-31

    Femoral nails, 320 mm right trochanteric, recalled over undersized shaft diameter

    Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509320, because an undersized distal shaft diameter could lead to implant fatigue fracture.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide