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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12176–12200 of 13802

  • HighFDA (Devices)·Z-0701-2022·2022-03-09

    Helix Elite Molecular Standards recalled due to shelf life test failure

    Microbiologics Inc is recalling Helix Elite Molecular Standards for Inactivated Influenza A/B and Respiratory Syncytial Virus because shelf life testing failed at 24 months, potentially affecting product stability.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2022·2022-03-09

    Lacrimedics Collagen Plugs recalled for potential sterility seal compromise

    Lacrimedics is recalling Collagen Plugs (models CP3, CP4, CP5) due to potential seal integrity defects in sterile pouches. The seals may contain channels that could compromise sterility and allow contamination.

    Product
    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2022·2022-03-09

    Abbott Alinity m reaction units risk detachment during transport

    Abbott Molecular is recalling 3063 kits of Alinity m Integrated Reaction Units due to potential detachment of reaction vessels from the unit cap during transport. No injuries have been reported.

    Product
    Alinity m Integrated Reaction Units (IRU)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MR Compatibility Claims

    BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2022·2022-03-09

    Titanium Toe Joint Implant Labeling Error: Unvalidated MRI Safety Claims

    BioPro Titanium MPJ toe implants are recalled due to false documentation claiming MRI safety testing that was never performed. Patients should not undergo MRI with this implant until properly evaluated.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0702-2022·2022-03-09

    da Vinci Surgical Cannula Reducer Metal Tip May Dislodge During Surgery

    Intuitive Surgical is recalling the da Vinci Xi and X 12-8 mm Conductive Cannula Reducer because the metal tip may dislodge from the plastic shaft. If unnoticed, additional surgery may be needed, or energy leakage could cause tissue damage.

    Product
    da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2022·2022-03-09

    Titanium Toe Joint Implant Contains False MR Compatibility Claims

    BioPro recalled titanium toe implants due to incorrect claims in documentation about magnetic resonance (MR) compatibility testing that was never conducted. The FDA issued a Class II recall to address the misleading safety information.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2022·2022-03-09

    BUTLER Clear Dip Recalled for Lack of FDA Premarket Clearance

    Sunstar Americas is recalling BUTLER Clear Dip nationwide due to lack of FDA premarket clearance. The product was distributed in 22,514 units across multiple lot codes.

    Product
    BUTLER Clear Dip, 12 bottles/case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0699-2022·2022-03-09

    Helix Elite Molecular Reference Standard Recall for Failed Shelf-Life Testing

    Microbiologics Inc is recalling Helix Elite Molecular Standards for inactivated RSV A because real-time shelf life testing failed at 24 months, indicating the product may not maintain stability through its claimed expiration date.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0693-2022·2022-03-09

    Regard TOTAL HIP surgical implant recalled due to incorrect product identification labeling

    ROi CPS LLC is recalling 50 kits of Regard TOTAL HIP implants distributed in Missouri due to incorrect product identification labeling on individual kits. This mislabeling could result in the wrong implant being used in surgery.

    Product
    Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0708-2022·2022-03-09

    OPAQUE Lacrimal Plugs recalled due to sterile pouch seal defect

    Lacrimedics is recalling approximately 5,767 units of OPAQUE Lacrimal Plugs due to potential defects in the sterile pouch seal that could compromise product sterility. The affected devices were distributed nationwide and internationally.

    Product
    OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0681-2022·2022-03-09

    Acorn stairlifts recalled due to inadequate seat structural strength

    Acorn Stairlifts Inc. is recalling multiple stairlift models because the seats may not have adequate strength to consistently support users during continued use, creating a fall hazard.

    Product
    Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0711-2022·2022-03-09

    Bronchial Microbiology Brush Labeling Error—Cleared Only for Gastrointestinal Use

    Hobbs Medical is recalling 38,357 Bronchial Microbiology Brushes due to labeling that incorrectly indicates bronchial use. The device is cleared only for gastrointestinal use.

    Product
    Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the shea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2022·2022-03-09

    Titanium MPJ Toe Implant Recalled for Incorrect MR Safety Labeling

    BioPro is recalling Titanium MPJ toe implants (Lot 125651) with inaccurate labeling claiming MR compatibility when the implant has not been tested for magnetic resonance safety. Patients should consult their physician before MRI.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2022·2022-03-09

    K2M Everest MI XT Outer Dilators recalled for manufacturing defect

    K2M is recalling 686 Everest MI XT Outer Dilator units due to a manufacturing nonconformance that prevents them from fitting properly with inner dilators during surgical procedures.

    Product
    Everest MI XT Outer Dilator, Catalog Number 5101-90168
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2022·2022-03-09

    Surgical knee navigation implant recalled over sterilization failures

    Orthosoft's NavitrackER knee navigation system may lack proper sterilization. The product was distributed without passing required sterilization tests, risking infection.

    Product
    NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant Recalled for Incorrect MR Compatibility Labeling

    BioPro is recalling Titanium MPJ toe implants because instructions and patient cards falsely claim the devices are compatible with MRI imaging, when safety testing for this titanium version has not been conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0703-2022·2022-03-09

    QC Control Sets for GBS Testing Recalled Due to Contamination

    Microbiologics QC sets used for GBS testing contain a negative control contaminated with Group B Streptococcus, causing test failures. Affects 541 units distributed nationwide.

    Product
    QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Gro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0697-2022·2022-03-09

    Microbiologics QC Panel Recalled Due to Shelf Life Testing Failure

    Microbiologics Inc is recalling its Helix Elite Extended Enteric Bacterial Verification Panel because real-time shelf life testing failed at 24 months.

    Product
    Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0679-2022·2022-03-09

    DARCO Locking Bone Plate System Recalled for Incorrect Manufacturing and Distribution Dates

    Wright Medical Technology is recalling the DARCO Locking Bone Plate System because product labels contain incorrect manufacturing and distribution dates. The recall affects 12 units distributed to Japan and the United Kingdom.

    Product
    The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The var
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0704-2022·2022-03-09

    Diagnostic Quality Control Material Yields False-Positive Results in GBS Testing

    A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.

    Product
    QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Grou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2022·2022-03-09

    LYFO-DISK Quality Control Kit Lot Fails Antibiotic Resistance Specification

    A lot of LYFO-DISK quality control kit was found susceptible to Gentamicin Synergy when it should have been resistant. The 153 affected units were distributed worldwide.

    Product
    LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0666-2022·2022-03-02

    Bard SureStep Intermittent Catheter Tray recalled for potential leak defect

    C.R. Bard is recalling 2,120 units of the BARD SURESTEP INTERMITTENT CATHETER TRAY (14Fr) due to a potential leak at the catheter-to-drain-bag connection.

    Product
    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0668-2022·2022-03-02

    Collagen Dura Substitute Membrane Recalled for Compromised Sterility

    Collagen Matrix is recalling 68 units of DuraMatrix-Onlay Collagen Dura Substitute Membrane due to unsealed outer packaging that may compromise product sterility and increase infection risk.

    Product
    DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2022·2022-03-02

    Biomet Shoulder Stem Implants Recalled for Coating Adhesion Defect

    Biomet is recalling certain shoulder stem implants due to potential insufficient adhesion strength in the porous plasma coating. An improper rework process may have compromised the coating's integrity.

    Product
    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
    Category
    Medical Device
    Distribution
    Distributed nationwide