The Recall Desk

Hazard

Manufacturing Defect recalls

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

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.

76–100 of 917

  • HighFDA (Devices)·Z-1008-2026·2026-01-07

    BVI Leos Laser Endoscopy System Recall: Missing USB Cable Ferrites

    The BVI Leos Laser and Endoscopy System is being recalled because ferrites were omitted from the USB cable assembly, potentially causing electromagnetic interference. Five units were distributed in Florida, Michigan, Oklahoma, Texas, and Wisconsin.

    Product
    BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2026·2025-12-31

    Cook Ring Transjugular Intrahepatic Access Sets Recalled for Manufacturing Defects

    Cook Incorporated is recalling 15 units of Ring Transjugular Intrahepatic Access Sets due to manufacturing defects. Affected devices may have been cut to incorrect length, improperly trimmed, and inadequately inspected.

    Product
    Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0995-2026·2025-12-31

    Rosch-Uchida Transjugular Liver Access Sets recalled for manufacturing defects

    Cook Incorporated is recalling 23 units of Rosch-Uchida Transjugular Liver Access Sets due to manufacturing specification defects. Devices may have been cut to incorrect lengths, improperly trimmed, or inadequately inspected.

    Product
    R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0973-2026·2025-12-31

    Zimmer Affixus Femoral Nails Recalled for Undersized Components

    Zimmer is recalling 22 Affixus Antegrade Femoral Nails due to undersized distal diameters that may cause implant fracture and complications including pain and tissue damage requiring surgery.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2026·2025-12-31

    Zimmer Affixus Femoral Nails recalled for potential implant fracture risk

    Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fracture, potentially leading to tissue damage requiring surgery. The recall affects 23 units distributed nationwide.

    Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2026·2025-12-24

    AART Malar Implant Recalled for Manufacturing Defects and Missing FDA Approval

    DSAART LLC is recalling AART Malar Implants due to manufacturing deviations and lack of FDA premarket approval. No illnesses or injuries have been reported.

    Product
    Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0938-2026·2025-12-24

    HemosIL SynthAFax Partial Thromboplastin Time Test Recalled for Manufacturing Defect

    Instrumentation Laboratory recalls HemosIL SynthAFax Partial Thromboplastin Time Tests (4,506 units) due to a manufacturing defect where recalled lots contained double the intended amount of preservative.

    Product
    HemosIL SynthAFax. Partial Thromboplastin Time Tests.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Drugs)·D-0225-2026·2025-12-17

    Drug Recall: Cinacalcet tablets contain excess nitrosamine impurity

    Cipla USA is recalling 15,744 bottles of Cinacalcet 60 mg tablets nationwide due to a manufacturing control deviation: N-nitroso-cinacalcet impurity above acceptable daily intake limits.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0218-2026·2025-12-17

    Lanthanum Carbonate Tablets Recalled Due to Failed Stability Test

    Cipla USA, Inc. is recalling Lanthanum Carbonate 1000mg chewable tablets (lot NB240314, exp. 12/31/2025) distributed nationwide due to failed hardness testing during stability studies.

    Product
    LANTHANUM CARBONATE — LANTHANUM CARBONATE (LANTHANUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0889-2026·2025-12-17

    Access 2 Reaction Vessels Recalled Due to Manufacturing Deformities

    Beckman Coulter is recalling 38,225 Access 2 Reaction Vessels that may have manufacturing deformities causing instrument errors and delays in patient test results.

    Product
    Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2026·2025-12-10

    Phantom Fibula Nail recalled due to thread specification defect

    Paragon 28 is recalling the Phantom Fibula Nail due to out-of-specification thread depths that may prevent proper mating with instrumentation, potentially requiring surgery to be aborted.

    Product
    Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0200-2026·2025-12-10

    Phenylephrine HCI Syringes Recalled Due to Manufacturing Process Violations

    Park Avenue Compounding is recalling 858 syringes of Phenylephrine HCI due to manufacturing deviations. The recall was voluntary and limited to Missouri.

    Product
    Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0216-2026·2025-12-10

    Prescription Duloxetine Recalled for Impurity Above FDA Limits

    Breckenridge Pharmaceutical recalls duloxetine capsules due to manufacturing deviations resulting in N-nitroso-duloxetine impurity above FDA recommended levels. The recall affects 7,389 bottles distributed nationwide.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0213-2026·2025-12-10

    Menthol and Zinc Oxide Topical Drug Recalled for Manufacturing Practice Deviations

    Blossom Pharmaceuticals recalls Wecare Calasoothe, an over-the-counter menthol and zinc oxide topical product, due to manufacturing practice deviations. The recall affects 2,400 containers distributed nationwide.

    Product
    MENTHOL AND ZINC OXIDE — MENTHOL AND ZINC OXIDE (MENTHOL AND ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0206-2026·2025-12-10

    Zinc oxide ointment recalled for manufacturing process deviations

    Blossom Pharmaceuticals is recalling NIVAGEN ZINC OXIDE ointment (Lot #A352318) nationwide due to manufacturing process deviations. Consumers should stop using the affected product.

    Product
    NIVAGEN ZINC OXIDE — NIVAGEN ZINC OXIDE (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·25V081000·2025-12-02

    2025 Volkswagen Atlas Transmission Defect May Cause Loss of Drive Power

    Volkswagen is recalling certain 2025 Atlas and Atlas Cross Sport vehicles because their transmissions may have been manufactured incorrectly, potentially resulting in sudden loss of drive power that increases crash risk.

    Product
    VOLKSWAGEN — 2025 VOLKSWAGEN ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0488-2026·2025-11-26

    FDA Recalls TMJ Bilateral Implants Due to Screw Hole Position Discrepancy

    TMJ Solutions Inc is recalling 63 TMJ bilateral implants (model CHG020) due to a discrepancy in screw hole positioning. The affected implants were distributed to patients in multiple U.S. states and internationally to Canada, Spain, and Brazil.

    Product
    TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0551-2026·2025-11-26

    SAFE-T-FILL Capillary Blood Collection System Recalled for Manufacturing Quality System Failures

    SAFE-T-FILL Micro Capillary Blood Collection devices are being recalled due to manufacturing quality system failures and unvalidated production processes. Approximately 103,200 units were distributed in the US and Canada.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2026·2025-11-26

    FDA Recalls SAFE-T-FILL Capillary Blood Collection Devices Due to Manufacturing Process Defect

    The FDA is recalling SAFE-T-FILL Micro Capillary Blood Collection devices because the manufacturer failed to validate its manufacturing processes, creating potential quality issues. The recall affects 50,050 units distributed nationwide.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2026·2025-11-26

    SAFE-T-FILL MicroHematocrit Capillary Tubes Recalled for Manufacturing Defects

    ASP Global recalls SAFE-T-FILL MicroHematocrit Capillary Tubes due to manufacturing under inadequate quality systems with unvalidated processes. No illnesses or injuries have been reported.

    Product
    SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2026·2025-11-26

    Medical Device Collection Tube Extender Recalled for Manufacturing Deficiencies

    ASP Global is recalling the SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004, due to manufacturing under an inadequate quality system with unvalidated processes. The recall affects 27,100 units distributed in the US and Canada.

    Product
    SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2026·2025-11-26

    Capillary Blood Collection Devices Recalled Due to Manufacturing Quality System Defects

    ASP Global recalls 9,150 SAFE-T-FILL capillary blood collection devices due to inadequate manufacturing quality and unvalidated manufacturing processes. Devices were distributed throughout the US and Canada.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2026·2025-11-26

    Greiner Vacuette Blood Collection Tubes Manufactured Without Required Gel Separator

    Greiner Bio-One is recalling 1.98 million Vacuette blood collection tubes manufactured without gel separator. The missing component can yield erroneous test results, requiring repeat testing and potentially delaying diagnosis.

    Product
    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0564-2026·2025-11-26

    SAFE-T-FILL End Caps for Blood Gas Capillaries Manufacturing Deficiency Recall

    ASP Global is recalling SAFE-T-FILL End Caps for blood gas capillaries manufactured under an inadequate quality system with unvalidated processes. Approximately 620,502 units distributed in the US and Canada may be affected.

    Product
    SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0168-2026·2025-11-26

    KleenFoam Antimicrobial Foam Soap Recalled Due to Manufacturing Control Deviation

    DermaRite Industries is recalling KleenFoam Antimicrobial Foam Soap cartridges due to manufacturing control (CGMP) deviations at the facility where contamination was found in other product lots. The product is distributed nationwide.

    Product
    KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
    Category
    Drug
    Distribution
    Distributed nationwide