Hazard

Manufacturing Defect recalls

1,434 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,434
Critical: 7
Severe: 107
Most recent: 2026-09-02

Of the 1,434 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 107 (7%) are Severe.

Which agencies issued them

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 1434

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-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 PREC
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-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 (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 int
Category
Medical Device
Distribution
7 states
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 (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-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 (Devices)·Z-0189-2025·2024-10-30
Smiths Medical TranStar Patient Mount Monitoring Kit recalled for pressure measurement defects
Smiths Medical recalls the medex TranStar Patient Mount Monitoring Kit (1,740 units) due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.
Product
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
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
HighFDA (Drugs)·D-0016-2025·2024-10-30
Phenylephrine Injection Recalled Due to Manufacturing Quality Violations
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
Product
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0205-2025·2024-10-30
Smiths Medical SurgiVet pressure transducer recalled for monitoring failures
Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.
Product
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Category
Medical Device
Distribution
0 states
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-0187-2025·2024-10-30
Smiths Medical Arterial Kit recalled for pressure monitoring defect
Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.
Product
medex Arterial Kit 1/EA, Product Code REF MX7827
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-0182-2025·2024-10-30
medex TranStar Pressure Transducer Recall Due to Manufacturing Defect
Smiths Medical recalls medex TranStar surgical pressure transducers worldwide due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.
Product
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
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-0017-2025·2024-10-30
Smiths Medical CADD Medication Cassette Recalled for Weld Defect Risk
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to a weakened weld joint between the medication bag and tubing, which could result in medication leakage. No injuries have been reported.
Product
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0195-2025·2024-10-30
Medex TranStar Pressure Transducer Recalled Due to Manufacturing Defect
Smiths Medical is recalling 1110 units of the medex TranStar DPT pressure transducer due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip failure within the device.
Product
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0022-2025·2024-10-30
FDA recalls epinephrine injection for manufacturing compliance violations
Fresenius Kabi Compounding recalled epinephrine 0.9% sodium chloride injections due to current good manufacturing practice violations. The recall affecting 753 bags distributed to 125 healthcare accounts was terminated on August 15, 2025.
Product
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
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