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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

13126–13150 of 13816

  • ModerateFDA (Devices)·Z-2408-2021·2021-09-08

    FaStep COVID-19 Test Devices Recalled for Unauthorized Laboratory Distribution

    Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.

    Product
    FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2367-2021·2021-09-08

    Palindrome RT Repair Kit voluntary withdrawal for labeling enhancements

    Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.

    Product
    Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2358-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement

    Covidien is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit to add point-of-use labeling and enhance instructions for use. The withdrawal affects specific lot numbers distributed worldwide.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2373-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kit Withdrawn for Labeling Enhancements

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to implement point-of-use labeling and enhanced instructions for use. No illnesses or injuries have been reported.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2371-2021·2021-09-08

    Palindrome Precision RT Catheter Kit Withdrawn for Labeling and Instruction Enhancements

    Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2393-2021·2021-09-08

    Steripath Luer Transport Pack Gen2 Recalled for Incorrect Instructions

    Magnolia Medical Technologies is recalling 9,400 units of Steripath Luer Transport Pack Gen2 because they were shipped with incorrect Transfer Adapter Instructions For Use (IFU).

    Product
    Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2372-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kits Withdrawn for Labeling and Instruction Updates

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2359-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Withdrawn for Labeling and Instructions Enhancement

    Covidien voluntarily withdrew Palindrome RT Chronic Catheter Kit worldwide to implement improved point-of-use labeling and enhanced instructions for use on each device.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2362-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement

    Covidien is voluntarily withdrawing specific lots of Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and enhancements to device instructions for use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2370-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kit recalled for labeling and instruction updates

    Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to add point-of-use labeling and improve Instructions for Use. No adverse events have been reported.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2369-2021·2021-09-08

    Palindrome RT Repair Kit Withdrawn for Labeling and Instruction Enhancements

    Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).

    Product
    Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2366-2021·2021-09-08

    Palindrome RT Repair Kit Withdrawn for Enhanced Labeling and Instructions

    Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.

    Product
    Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2375-2021·2021-09-08

    Covidien Palindrome Chronic Catheter Kits Withdrawn to Enhance Labeling and Instructions

    Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2363-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling and Instruction Updates

    Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2374-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Withdrawn for Labeling Updates

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance Instructions for Use.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2285-2021·2021-09-01

    Monoject Sodium Chloride Flush Syringes Recalled for Air Embolism Risk

    Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2286-2021·2021-09-01

    Sodium Chloride Flush Syringe Recalled Due to Plunger Malfunction Risk

    Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringes because the plunger may draw back after use and reintroduce air into the syringe.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2284-2021·2021-09-01

    Monoject flush syringe recall: plunger may reintroduce air into IV lines

    Cardinal Health Monoject flush syringes may have a defect allowing the plunger to draw back and reintroduce air into the syringe. The FDA issued a Class I recall for over 267 million units distributed nationwide.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2345-2021·2021-09-01

    MRI System Pressure Valve Installation Error Poses Helium Release Risk

    A wrong pressure relief valve was installed in Ingenia CX 3.0T MRI systems, which may release helium gas and cause injury to patients and staff.

    Product
    Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2021·2021-09-01

    Gore Balloon Catheter Leakage Recall Affects 3,364 Units Worldwide

    W.L. Gore is recalling 3,364 units of its Molding & Occlusion Balloon Catheter due to leakage from the guidewire lumen and y-hub that can prevent proper inflation. No injuries have been reported.

    Product
    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2021·2021-09-01

    MRI System Pressure Relief Valve Defect May Release Helium Gas

    Philips MRI systems contain an incorrectly rated pressure relief valve that may release helium gas and cause injury. The system was installed with a 42 psi valve instead of the required 3.75 psi valve.

    Product
    Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2021·2021-09-01

    MRI System Table Pads Missing Required Natural Rubber Allergen Label

    Table pads in Hitachi's ECHELON Oval MRI System contain natural rubber but lack required labeling on packaging and in user manuals. Federal regulations under 21 CFR 801.437 mandate disclosure of this material.

    Product
    ECHELON Oval MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2021·2021-09-01

    Accu-Chek SmartView Test Strips May Open During Shipment

    Roche is recalling Accu-Chek SmartView Test Strip vials that may open during shipment. The vials can be exposed to humidity, damaging the strips and potentially causing inaccurate glucose readings.

    Product
    Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
    Category
    Medical Device
    Distribution
    Distributed nationwide