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 the agency’s own highest classification or reported deaths or serious injuries, 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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10551–10575 of 27441

  • HighFDA (Devices)·Z-0363-2022·2021-12-22

    Smith & Nephew EVOS femur plates recalled for erroneous MRI instructions

    Smith & Nephew is recalling 38 EVOS femur plates because the product instructions contain erroneous MRI scanning conditions. The affected units were distributed nationwide across 14 states.

    Product
    smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2022·2021-12-22

    EVOS Medial Distal Femur Plate IFU contains erroneous MRI scanning conditions

    Smith & Nephew recalled EVOS Medial Distal Femur Plates because the Instructions for Use contain erroneous MRI scanning data that was incorrectly incorporated from a vendor report.

    Product
    smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2022·2021-12-22

    MENTOR Saline-Filled Breast Implants Recalled for Deflation Risk

    Mentor Texas is recalling 28,348 MENTOR Saline-Filled Breast Implants due to a manufacturing defect that may cause a weakened base patch, potentially leading to implant leakage or deflation.

    Product
    MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2022·2021-12-22

    FDA Updates Instructions for Miami J Select Collar Device

    Ossur Americas is updating instructions for the Miami J Select Collar (MJS-101) and Miami J Select Collar Set (MJSR-101) to provide additional guidance on device selection and proper use nationwide.

    Product
    Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2022·2021-12-22

    Medline Vascular CDS Kit Recalled for Expired Saline Component

    Medline Industries is recalling the Major Vascular CDS Convenience Kit because a 250 mL saline injectable component expired in April 2020, while the overall kit's expiration date was July 31, 2021. Medical professionals should stop using affected kits immediately.

    Product
    Major Vascular CDS Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled Due to Compromised Packaging Seals

    Cardinal Health Poly-Reinforced Surgical Gowns (XX-large, SKU 9070) are recalled due to potential open packaging seals that could compromise sterility. Approximately 29,893 units distributed worldwide may be affected.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled for Potential Packaging Seal Defects

    Cardinal Health is recalling 169,262 SmartSleeve surgical gowns due to potential package seal defects that could compromise sterility. Multiple affected lot numbers span 2020-2021 production with worldwide distribution.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0386-2022·2021-12-22

    Activforce 2 force measurement device recalled for inaccurate measurement

    Activforce 2 medical devices (145 units) are being recalled due to a manufacturing defect causing inaccurate force measurement, which may lead to incorrect treatment planning. Verify your device's serial number against the FDA recall list.

    Product
    activforce 2 package labeling: Model: Activ5-M R 201-200563
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0377-2022·2021-12-22

    Cardinal Health RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health has recalled RoyalSilk Non-Reinforced Surgical Gowns XX-large due to the potential for packaging seals to open, which could compromise product sterility. The recall affects approximately 9,990 units distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2022·2021-12-22

    RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health is recalling 270,839 units of RoyalSilk Non-Reinforced Surgical Gowns (X-large, SKU 9548) due to potential packaging seal failures that could compromise sterility.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2022·2021-12-22

    Activ5 Smart Fitness Device Recalled for Inaccurate Force Measurement

    Activbody is recalling the Activ5 smart fitness device due to manufacturing defects causing inaccurate force measurements, which may lead to incorrect treatment planning. The device was distributed nationwide.

    Product
    Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0389-2022·2021-12-22

    X-ray therapy applicator base plates may detach from device body

    Xstrahl Limited is recalling treatment applicators for Gulmay Medical 150 and Xstrahl 150 X-ray therapy systems. The base plate may detach from the applicator body, potentially affecting treatment positioning and delivery.

    Product
    Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0358-2022·2021-12-22

    EVLP Convenience Pack Recalled for Expired Injectable Component

    Medline Industries is recalling EVLP Convenience Pack/Kit due to a NaCl injectable component that expired in April 2020, despite the kit's label showing a later expiration date. Users may unknowingly use expired medication.

    Product
    EVLP Convenience Pack/Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2022·2021-12-22

    Surgical Gowns Recalled Due to Potential Packaging Seal Defects

    Cardinal Health is recalling SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns (X-Large, SKU 9041) due to potential open packaging seals that could compromise sterility. The recall affects 231,219 units distributed worldwide.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0344-2022·2021-12-15

    Puritan Bennett 980 Series Ventilators Recalled for Incorrect Capacitor Assembly

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient use.

    Product
    Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0342-2022·2021-12-15

    Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error

    Puritan Bennett 980 Series Ventilators are recalled due to an assembly error in a capacitor that may cause the device to become inoperable during use. The recall affects 278 units.

    Product
    Puritan Bennett 980 Series Ventilator, 980U1ENASAA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0339-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Assembly Defect

    Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980A3ENNISB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0343-2022·2021-12-15

    Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error

    Covidien is recalling the Puritan Bennett 980 Series Ventilator due to incorrect capacitor assembly that may cause the device to become inoperable during patient use.

    Product
    Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0341-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall Due to Manufacturing Defect

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing error where a capacitor was assembled incorrectly, which may cause the device to become inoperable during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980S3ENDICU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0346-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Capacitor Assembly Defect

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980X1ENDIPC) due to incorrect capacitor assembly that may cause the device to malfunction during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0335-2022·2021-12-15

    OsteoMed Surgical Consoles Recalled for Electrical Safety Violations

    OsteoMed OsteoPower Power Consoles and footswitches are being recalled due to non-compliance with electrical safety standard IEC 60601. The product has shocked a patient, creating a significant electrical hazard.

    Product
    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0349-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator recalled for assembly defect

    Puritan Bennett 980 Series Ventilators are recalled due to a capacitor assembly error that may cause the device to become inoperable during use. The recall affects 278 units distributed worldwide.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0352-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall - Capacitor Assembly Error

    Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) due to a capacitor assembly error that may cause the device to become inoperable during patient use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0347-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Assembly Defect

    Covidien LLC is recalling 278 units of the Puritan Bennett 980 Series Ventilator due to a manufacturing defect that may cause the device to become inoperable during clinical use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0340-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Defect

    Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error where a capacitor may have been installed incorrectly, potentially causing device inoperability during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980S1ENDICU
    Category
    Medical Device
    Distribution
    Distributed nationwide