The Recall Desk

Hazard

Manufacturing Defect recalls

1,441 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,441
Critical
7
Severe
114
Most recent
2026-10-21

Of the 1,441 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 114 (8%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

201–225 of 1441

  • ModerateFDA (Drugs)·D-0066-2025·2024-12-04

    FDA Recalls Menthol Medicated Patches Due to Manufacturing Deviations

    FDA recalls THERA CARE COLD HOT MEDICATED PATCH (menthol 5%) due to manufacturing practice deviations. The voluntary recall affects 279,936 patches distributed nationwide.

    Product
    THERA CARE COLD HOT MEDICATED PATCH — THERA CARE COLD HOT MEDICATED PATCH (MENTHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0064-2025·2024-12-04

    Absorbine Jr Pain Relieving Knee Patch recalled for manufacturing deviations

    Unexo Life Sciences is recalling Absorbine Jr Pain Relieving Knee Patch nationwide due to manufacturing process deviations that do not meet FDA standards. No illnesses or injuries have been reported.

    Product
    ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0069-2025·2024-12-04

    LILAS Feminine Pain Relief Patch recalled for manufacturing violations

    Unexo Life Sciences is voluntarily recalling LILAS Feminine Pain Relief Patch nationwide due to manufacturing practice deviations affecting 363,300 patches.

    Product
    LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect

    Abbott Medical is recalling the Navitor 29mm transcatheter aortic heart valve due to a manufacturing error affecting leaflet specifications. The defect could potentially impact long-term valve durability or cause valve failure.

    Product
    Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0495-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Valve Recalled for Manufacturing Defect

    Abbott is recalling Abbott Navitor Transcatheter Aortic Heart Valves (27 mm) due to a manufacturing error causing leaflet deflection values outside specifications. This could affect valve durability and potentially cause valve failure.

    Product
    Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0494-2025·2024-11-27

    Abbott Navitor Heart Valve Recalled for Leaflet Deflection Manufacturing Defect

    Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve due to a manufacturing error in leaflet deflection that may affect valve durability and function.

    Product
    Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0493-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect

    Three Abbott Navitor 29mm transcatheter aortic heart valves were recalled due to a manufacturing error that allowed valves with leaflet deflection outside specifications to be distributed. The defect could affect valve durability or cause valve failure.

    Product
    Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0491-2025·2024-11-27

    Abbott Navitor Titan Heart Valve Recall: Manufacturing Defect

    Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.

    Product
    Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0496-2025·2024-11-27

    Siemens Atellica CH Cuvette Segment manufacturing defect may impact lab test accuracy

    Manufacturing defects in Siemens Atellica CH Cuvette Segments may cause inaccurate laboratory test results for seven analytes across 9,729 units.

    Product
    Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0056-2025·2024-11-27

    Vitamin D3 Dietary Supplement Recalled for Packaging Defect

    Safecor Health is recalling specific lots of Vitamin D3 25 mcg tablets due to a manufacturing defect where blister card-foils may separate from the blister cavity. No illnesses or injuries have been reported.

    Product
    Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0500-2025·2024-11-27

    Precice Max Orthopedic Implants Recalled for Design and Manufacturing Validation Issues

    NuVasive Specialized Orthopedics is recalling 164 Precice Max orthopedic implants distributed to Florida and Nevada due to potential design, manufacturing, and documentation validation issues.

    Product
    Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0330-2025·2024-11-20

    VYGON 100 mL IV Container Pouch Recalled for Potential Leakage

    The Metrix Company is recalling a limited number of VYGON 100 mL empty IV containers (Lot Numbers 62040-A8375 and 62040-A8432) due to leakage found during the filling process. The affected containers are distributed in multiple U.S. states and Canada.

    Product
    VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0032-2025·2024-11-06

    Cinacalcet 90 mg Tablets Recalled for Nitrosamine Impurity Above Safety Limits

    Accord Healthcare is recalling Cinacalcet 90 mg tablets nationwide due to nitrosamine impurity (N-nitroso-cinacalcet) at levels exceeding the FDA's acceptable daily intake limit. The issue stems from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0230-2025·2024-11-06

    LIFEPAK 15 Monitor/Defibrillator Recalled Due to Manufacturing Tool Defect

    Physio-Control is recalling 105 LIFEPAK 15 monitor/defibrillator systems due to a manufacturing defect caused by an out-of-tolerance tool used during assembly. Affected units were distributed in Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, and West Virginia.

    Product
    LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-0028-2025·2024-11-06

    Prescription Drug Recall: Cinacalcet Tablets for N-nitroso Impurity

    Dr. Reddy's Laboratories is recalling Cinacalcet 90 mg tablets due to N-nitroso impurity exceeding FDA limits. Patients should contact their healthcare provider.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0030-2025·2024-11-06

    Accord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Contamination

    Accord Healthcare is recalling Cinacalcet 30mg tablets nationwide due to a nitrosamine impurity (N-nitroso-cinacalcet) exceeding acceptable daily intake limits. Patients should consult their healthcare provider to confirm if their medication is affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0026-2025·2024-11-06

    Cinacalcet tablets recalled for manufacturing impurity exceeding FDA limits

    Dr. Reddy's Laboratories recalls Cinacalcet 30 mg tablets nationwide due to manufacturing defects that produced N-nitroso impurity above FDA recommended limits. Patients should contact their healthcare provider if they are taking an affected lot.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0023-2025·2024-10-30

    Injectable Thiamine Drug Recalled for Manufacturing Compliance Violations

    Fresenius Kabi Compounding recalled 1,008 bags of Thiamine HCl injectable due to current good manufacturing practice violations. The recall was voluntary and nationwide distribution affected 125 accounts.

    Product
    Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2025·2024-10-30

    Medex TranStar Pressure Transducer Recalled for Manufacturing Defect Affecting Monitoring

    Smiths Medical is recalling 3080 medex TranStar pressure transducers with a manufacturing defect that may cause inaccurate, interrupted, or absent pressure monitoring. The defect stems from leaks or chip failures in the transducer.

    Product
    medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0190-2025·2024-10-30

    medex TranStar Pressure Monitoring Kit Recalled for Manufacturing Defect

    Smiths Medical is recalling the medex TranStar 72-inch Double Monitoring Kit due to a manufacturing defect in the pressure transducer that may cause inaccurate pressure readings or monitoring interruptions. Approximately 6,590 units have been distributed worldwide.

    Product
    medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0198-2025·2024-10-30

    Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits

    Smiths Medical ASD, Inc. is recalling 900 units of medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT due to a manufacturing defect that may cause inaccurate pressure monitoring.

    Product
    medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0013-2025·2024-10-30

    CADD Medication Cassette Reservoirs Recalled for Weakened Weld Defects

    Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to weakened weld joints that may cause medication leakage during use.

    Product
    CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0016-2025·2024-10-30

    CADD Medication Cassette Reservoir Recall Due to Defective Weld Joint

    Smiths Medical is recalling CADD Medication Cassette Reservoirs with defective weld joints that may cause medication leakage. The issue affects 8,976 units distributed worldwide.

    Product
    CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0196-2025·2024-10-30

    medex TranStar Neonatal Monitoring Kit Recalled Due to Pressure Transducer Defect

    Smiths Medical is recalling the medex TranStar Neonatal Monitoring Kit due to manufacturing defects in the pressure transducer that may cause inaccurate readings or monitoring failures.

    Product
    medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
    Category
    Medical Device
    Distribution
    0 states