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 13802

  • 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-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-0665-2022·2022-03-02

    BD Vacutainer Luer Lok Access Device may shed particles causing false test results

    BD's Vacutainer Luer Lok Access Device may release contaminant particles that can be misidentified as red blood cells in laboratory analysis, potentially leading to false elevated RBC counts.

    Product
    BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog
    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-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-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-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-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
  • 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-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-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-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-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-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-0660-2022·2022-03-02

    Optima Coil System Recalled for Labeling and Packaging Mix-Up

    BALT USA recalls Optima Coil System embolization devices due to labeling/pouch mix-up that could result in incorrect device selection during surgical procedures. Potential harms include vessel damage and aneurysm rupture.

    Product
    The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0678-2022·2022-03-02

    ImmunoCard STAT Rotavirus diagnostic tests recalled for improper storage temperature

    Meridian BioscienceImmunoCard STAT! Rotavirus tests were shipped at room temperature instead of refrigerated, which may affect their reliability.

    Product
    meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotaviru
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0656-2022·2022-03-02

    Medline Michels Transport Medium Recalled for Improper Storage Conditions

    Medline is recalling 2,816 Michels Transport Medium prefilled containers due to improper storage in a temperature-controlled setting instead of refrigeration.

    Product
    Michels Transport Medium, 20ML Prefilled Cont
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0628-2022·2022-02-23

    Arrow-Trerotola Thrombolytic Catheter Kits Recalled for Tip Separation During Use

    Teleflex Medical is recalling 5,530 Arrow-Trerotola PTD catheter kits due to reports of tip separation during use. The hazard could prevent the device from functioning properly to remove blood clots from dialysis access grafts.

    Product
    5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0629-2022·2022-02-23

    Arrow-Trerotola Percutaneous Thrombolytic Device Set Tip Separation Recall

    Teleflex Medical Inc. is recalling Arrow-Trerotola PTD catheter sets due to reported tip separation during use. The device is used for mechanical declotting of vascular access fistulae and grafts.

    Product
    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0623-2022·2022-02-23

    Arrow-Trerotola Thrombolytic Device Tip Separation During Use Recalled

    Teleflex Medical is recalling Arrow-Trerotola PTD kits due to reports of tip separation during use. The affected device is used for declotting dialysis grafts and fistulae.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0626-2022·2022-02-23

    Arrow-Trerotola Percutaneous Thrombolytic Device Kits Recalled for Tip Separation

    Teleflex is recalling Arrow-Trerotola Percutaneous Thrombolytic Device kits worldwide due to reports of tip separation during use, affecting approximately 1,874 units.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0625-2022·2022-02-23

    Arrow-Trerotola Dialysis Catheter Recalled for Tip Separation During Use

    Arrow-Trerotola Over-The-Wire PTD catheters used in dialysis procedures are being recalled due to reports of tip separation during use. The FDA classified this as a Class I recall affecting 1,265 units worldwide.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of nati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0624-2022·2022-02-23

    Teleflex Arrow-Trerotola Percutaneous Thrombolytic Device PTD Kit recalled for tip separation

    Teleflex recalls approximately 1,400 Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) kits due to reports of tip separation during use. The medical device is used for dialysis graft declotting and has been distributed worldwide.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0622-2022·2022-02-23

    Vyaire Medical Ventilators Recalled Due to Potential Ventilation Failure

    Vyaire Medical is recalling 4,189 bellavista 1000 and 1000e ventilators worldwide due to potential cessation of ventilation under specific conditions. This FDA Class I recall poses serious risk to patients who depend on these critical care devices.

    Product
    bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0568-2022·2022-02-23

    RNAstill Specimen Collection Kits Recalled Missing FDA 510(k) Clearance

    BASE 10 GENETICS INC is recalling RNAstill Molecular Transport Medium Vials and specimen collection kits nationwide because they lack FDA 510(k) clearance. Approximately 455,791 kits were distributed across 18 states.

    Product
    RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleev
    Category
    Medical Device
    Distribution
    Distributed nationwide