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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12201–12225 of 13816

  • HighFDA (Devices)·Z-0655-2022·2022-03-09

    Digital Angiography System generator may exceed safe radiation dose rates

    Shimadzu recalled 28 Digital Angiography Systems with Generator Model D150GC-40 due to inadequate installation adjustment criteria that may cause x-ray radiation dose rates to exceed safe fluoroscopic imaging limits.

    Product
    Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
    Category
    Medical Device
    Distribution
    15 states
  • 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-0715-2022·2022-03-09

    Stryker medical implant recalled for manufacturing defect in barrier layer

    Stryker is recalling MEDPOR Titan OFW implants after one unit was found with an incorrectly placed barrier layer. The defect resulted from manufacturing error rather than design.

    Product
    MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
    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
  • 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-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-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
  • 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
  • HighFDA (Devices)·Z-0672-2022·2022-03-02

    Biomet Shoulder Implant Stem Recalled for Inadequate Coating Adhesion

    Biomet is recalling a Comprehensive Shoulder System implant component due to a defect in the porous plasma coating. The coating may not have sufficient adhesion strength, compromising the implant's structural integrity.

    Product
    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2022·2022-03-02

    Biomet Shoulder Implant Stem Coating Adhesion Defect Recall

    Biomet is recalling shoulder implant stems due to improper rework of porous plasma coating, which may lack sufficient adhesion strength. Affected units may fail if the coating detaches.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0674-2022·2022-03-02

    Comprehensive Shoulder System Mini Humeral Stem Recalled for Coating Adhesion Defect

    Biomet recalls 11 units of its Comprehensive Shoulder System Mini Humeral Stem due to potential coating adhesion defects. An unvalidated rework process was applied to vendor-coated parts, risking implant failure.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2022·2022-03-02

    Hip implant revision system recalled due to inadequate coating adhesion

    Biomet is recalling 19 units of the Arcos Modular Revision Hip System because an incorrect rework process may have weakened the coating's adhesion strength, posing a potential implant failure risk.

    Product
    Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0671-2022·2022-03-02

    Shoulder Implant Stem Coating Defect Due to Invalid Rework Process

    Biomet is recalling a shoulder implant stem due to a manufacturing defect in the porous plasma coating. Internal testing indicated the coating may not have sufficient adhesion strength after an unvalidated waterjet rework process.

    Product
    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2022·2022-03-02

    Bard Surestep Intermittent Catheter Tray Recalled for Connection Leaks

    C.R. Bard Inc recalled 1,620 units of Bard Surestep Intermittent Catheter Tray because the catheter may leak where it connects to the drain bag. No injuries have been reported.

    Product
    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2022·2022-03-02

    Medtronic Endurant Stent Graft Systems: Taper Tip Detachment Risk

    Certain Medtronic Endurant stent graft systems may have taper tips that detach from the delivery system during implant procedures, potentially requiring secondary surgical intervention.

    Product
    Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2022·2022-03-02

    Shoulder Implant Stem Recalled for Defective Coating Adhesion

    Biomet is recalling Comprehensive Shoulder System Mini Humeral Stems due to defective porous plasma coating adhesion. Internal testing indicated affected parts may lack sufficient coating strength.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
    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-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
  • 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-0658-2022·2022-03-02

    NobelReplace dental implant components recalled for driver engagement defect

    Nobel Biocare is recalling 702 NobelReplace dental implant components due to a manufacturing defect that prevents proper driver engagement. The defect could result in aborted or delayed surgical procedures.

    Product
    NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2022·2022-03-02

    Biomet Shoulder Implant Stem Recalled for Coating Adhesion Defect

    Biomet recalls 9 Comprehensive Shoulder System Mini Humeral Stems due to potential coating adhesion defects. An incorrect rework process may have compromised the porous plasma coating adhesion strength.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2022·2022-03-02

    RESODURA Matrix Onlay Recalled Due to Unsealed Packaging

    Collagen Matrix is recalling RESODURA matrix onlay dural substitutes due to outer packaging that is not properly sealed, potentially compromising sterility and creating a risk of infection.

    Product
    RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0664-2022·2022-03-02

    Stryker Color Cuff tourniquet cuff mislabeled as single-bladder when dual-bladder

    Stryker Sustainability Solutions is recalling 40 units of Color Cuff 18" tourniquet cuffs (Lot #12983349) because they are mislabeled as single-bladder when they are actually dual-bladder, creating a risk of incorrect clinical use.

    Product
    REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
    Category
    Medical Device
    Distribution
    3 states