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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8101–8125 of 40007

  • HighFDA (Devices)·Z-0902-2024·2024-02-07

    Knee Replacement Component Recalled for Potential Material Oxidation and Degradation

    Howmedica Osteonics is recalling TRIDENT 0 deg knee implant components manufactured with aged raw material that may have elevated oxidation levels, potentially affecting material properties.

    Product
    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2024·2024-02-07

    Custom Surgical Procedure Kits Recalled for Sterilization Assessment Failures

    American Contract Systems has recalled 2,717 custom surgical procedure kits used in neurosurgery nationwide. Components were added without proper assessment of their suitability for the sterilization process.

    Product
    Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2024·2024-02-07

    Philips Ingenia 3.0T CX MRI: Loose Coil Seal May Cause Sharp Edges

    Philips is recalling Ingenia 3.0T CX MRI machines due to potential failure of the Quadrature Body Coil seal adhesive. Loose seals may create sharp edges that risk skin injury or hair entanglement during scanning.

    Product
    Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2024·2024-02-07

    Knee replacement inserts recalled for potential material oxidation

    Howmedica Osteonics Corp. is recalling LEFT LARGE-PCA knee replacement inserts manufactured with raw material over 5 years old due to potential elevated oxidation levels that could affect material properties.

    Product
    LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0924-2024·2024-02-07

    Knee Replacement Insert May Degrade from Oxidized Raw Material

    Howmedica Osteonics is recalling PS LIPPED TIBIAL INSERT ASSY DURACON knee replacement inserts manufactured with UHMWPE raw material over 5 years old. The aged material may develop elevated oxidation that could impact material properties.

    Product
    PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2024·2024-02-07

    Knee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk

    Knee replacement tibial inserts from Howmedica may have elevated oxidation if manufactured with raw material over 5 years old, potentially affecting material properties.

    Product
    DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2024·2024-02-07

    Custom Ear, Nose and Throat Surgical Kits Recalled Due to Sterilization Validation Failure

    American Contract Systems is recalling 804 custom ear, nose and throat surgical kits nationwide because components were sterilized without validation that they could tolerate the process, potentially affecting functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2024·2024-02-07

    Custom Cardiac Procedural Kits Recalled for Inadequate Sterilization Assessment

    American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2024·2024-02-07

    Knee Replacement Implant Recalled for Potential Material Degradation Risk

    Howmedica Osteonics Corp. is recalling SCORPIO TS TIB knee replacement implants manufactured with aged raw material that may develop oxidation, potentially affecting performance.

    Product
    SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2024·2024-02-07

    EZDilate Fixed Wire Balloon Recalled for Device Failure and Foreign Body Risk

    Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.

    Product
    EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0875-2024·2024-02-07

    Knee replacement implant recalled for potential material oxidation

    Howmedica Osteonics recalls SCORPIO TS TIB knee replacement inserts (lot TA21X9) manufactured from UHMWPE material over 5 years old due to potential elevated oxidation that could affect material properties. No injuries reported.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2024·2024-02-07

    Custom OB/GYN Procedural Kits Recalled for Sterilization Process Failure

    American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2024·2024-02-07

    Knee Replacement Insert Recalled Due to Potential Material Oxidation

    Howmedica Osteonics recalls SCORPIO TS TIB INSERT knee replacement components manufactured with UHMWPE raw material over 5 years old, which may experience elevated oxidation affecting material properties. No injuries or illnesses have been reported.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2024·2024-02-07

    Knee Replacement Component Recalled Due to Raw Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0865-2024·2024-02-07

    GE Voluson IC9-RS Ultrasound Probes Recalled for Double Image Artifacts

    GE HealthCare is recalling certain IC9-RS intracavitary ultrasound probes due to a double image artifact that creates ghost images. This unrecognized artifact can lead to diagnostic errors.

    Product
    GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0920-2024·2024-02-07

    Knee replacement devices recalled due to potential material degradation

    Howmedica Osteonics Corp. recalls knee replacement devices with UHMWPE components manufactured from raw material over 5 years old due to potential oxidation that may affect material properties.

    Product
    DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2024·2024-02-07

    Knee replacement component recalled due to potential material oxidation

    Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2024·2024-02-07

    Urological procedural kits recalled due to sterilization defects

    American Contract Systems recalled 1,031 urological procedure kits nationwide due to sterilization process defects. Components may have damaged functionality, reduced drug efficacy, or elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2024·2024-02-07

    Achieva 1.5T MRI Coil Seal Adhesive May Fail Creating Sharp Edges

    Philips Achieva 1.5T MRI scanner components may experience coil seal adhesive failure, creating sharp edges that could injure patients. Affected devices have been distributed worldwide.

    Product
    Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2024·2024-02-07

    Knee Replacement Implant Component Recalled Due to Material Oxidation Risk

    The FDA is recalling SCORPIO U-DOME PATELLA knee replacement components because manufacturing used raw material over 5 years old that may have elevated oxidation levels affecting the implant's material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0845-2024·2024-02-07

    Surgical sutures recalled due to substandard gamma sterilization doses

    Covidien is recalling multiple surgical suture products because certain lots were sterilized with gamma doses exceeding approved levels. The excess radiation may reduce suture strength over time, potentially causing wound failure and bleeding.

    Product
    Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2024·2024-02-07

    Knee Replacement Implant Component Recalled for Material Degradation Risk

    Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella components due to potential oxidation in raw materials over 5 years old. No illnesses have been reported.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2024·2024-02-07

    Medline Blood Culture Kits Recalled: Expired Component Not Disclosed on Insert

    Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.

    Product
    MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0908-2024·2024-02-07

    Knee Replacement Inserts Recalled Due to Material Oxidation Risk

    Howmedica Osteonics is recalling knee replacement inserts manufactured with UHMWPE material over 5 years old, which may develop elevated oxidation levels that could affect joint stability.

    Product
    LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2024·2024-02-07

    Knee Replacement Component Recalled for Potential Material Degradation

    Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA knee replacement components due to potential oxidation in raw materials over 5 years old, which could affect material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
    Category
    Medical Device
    Distribution
    Distributed nationwide