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.

376–400 of 1441

  • HighFDA (Devices)·Z-1142-2024·2024-02-28

    Dental cement capsules recalled due to manufacturing defect affecting curing

    IonoStar Plus dental cement capsules contain an incorrect plunger due to a manufacturing error. The defect prevents proper curing of the cement, making the product unsuitable for use.

    Product
    IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0338-2024·2024-02-28

    Pure Care Foaming Mint Hand Sanitizer recalled for manufacturing deviations

    Pure Care Foaming Mint Hand Sanitizer has been voluntarily recalled due to manufacturing process deviations. The product was distributed to accounts in North Carolina and Michigan.

    Product
    Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.
    Category
    Drug
    Distribution
    2 states
  • HighNHTSA·24V138000·2024-02-23

    BMW X5 and X7 instrument panels may separate during airbag deployment

    BMW is recalling certain 2024 X5 and X7 vehicles because the instrument panel may not have been manufactured properly, which can result in improper airbag deployment or panel separation.

    Product
    BMW — BMW X7, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2024·2024-02-21

    Bone Filler Tubes Recalled Due to Manufacturing Process Defect

    The FDA is recalling 89 AFT Bone Filler Tubes due to a manufacturing process defect that could cause extrudability issues during surgery. The filling process did not demonstrate adequate capability.

    Product
    AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0857-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0852-2024·2024-02-14

    Cardinal Health Monoject Sterile Syringes Recalled for Manufacturing Change

    Cardinal Health is recalling Monoject sterile syringes due to manufacturing changes. The recall affects Luer-Lock and Enteral syringe models distributed in the US and Canada.

    Product
    Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0858-2024·2024-02-14

    Cardinal Health Monoject Sterile Syringes Removed Due to Manufacturing Change

    Cardinal Health 200, LLC is recalling all sizes of Monoject brand sterile syringes (both Luer-Lock and ENFit enteral types) due to manufacturing and rebranding changes. The recall expands previous correction actions to a complete product removal.

    Product
    Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0856-2024·2024-02-14

    Cardinal Health Monoject sterile syringes recalled due to manufacturing changes

    Cardinal Health is recalling all sizes of its Monoject sterile syringes (Luer-Lock and ENFit models) nationwide due to manufacturing and rebranding changes. The FDA classified this as a Class I recall.

    Product
    Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0851-2024·2024-02-14

    Cardinal Health Monoject Syringes and Enteral Syringes Removed

    Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0859-2024·2024-02-14

    Cardinal Health Monoject Syringes Removal Due to Manufacturing Changes

    Cardinal Health is removing Monoject brand syringes due to manufacturing changes and rebranding efforts. The removal includes Luer-Lock and ENFit connection models distributed nationwide in the US and Canada.

    Product
    Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2024·2024-02-14

    PulseSpray Infusion System O-Ring Defect May Cause Medication Leaks

    Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.

    Product
    PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0979-2024·2024-02-14

    Barco MDSC-8527 NXF Medical Display decoder functionality blocked

    Barco is recalling MDSC-8527 NXF medical displays due to I2C cable defects in manufacturing that block the MNA decoder functionality. The recall affects a limited batch distributed in New Jersey.

    Product
    Barco MDSC-8527 NXF, Part Number K9352421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0282-2024·2024-02-07

    FDA Recalls Vancomycin IV Bags Due to Dosing System Malfunction

    Denver Solutions is recalling 7,548 IV bags of vancomycin due to a manufacturing system malfunction that can deliver double doses. The product was distributed nationwide.

    Product
    VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2024·2024-02-07

    Tank hose assembly recalled for incorrect material and missing perforations

    AtriCure recalls tank hose assemblies due to manufacturing defects. Certain lots have outer sheaths missing required pin perforations and inner tubes made of incorrect material.

    Product
    Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0275-2024·2024-02-07

    FDA Recalls Budesonide Extended-Release Tablets for Failed Dissolution

    FDA has recalled approximately 10,672 bottles of Budesonide Extended-Release Tablets 9mg manufactured by Teva Pharmaceuticals due to failed dissolution specifications.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0259-2024·2024-01-31

    Fluocinolone Acetonide Ear Drops Recalled Due to Failed Specification

    Glenmark Pharmaceuticals is recalling Fluocinolone Acetonide Oil 0.01% ear drops due to failed excipient specifications. The affected lots nationwide do not meet required quality standards for isopropyl alcohol content.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0744-2024·2024-01-24

    High Pressure Rotator with O-Ring Seal Defect Recalled Worldwide

    Smiths Medical is recalling High Pressure Rotators due to a manufacturing defect affecting O-ring seals. An oversized inner diameter may cause inadequate seal integrity, risking medication under-infusion.

    Product
    HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0247-2024·2024-01-24

    Secret OUTLAST Dry Spray Antiperspirant recalled for potential benzene contamination

    Procter & Gamble is recalling Secret OUTLAST Dry Spray Antiperspirant due to a manufacturing facility deviation where other lots were found contaminated with benzene. The recalled product was manufactured at the affected facility.

    Product
    Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Completely Clean, Topical spray can 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-384-10, UPC 0 37000 74764 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2024·2024-01-24

    Medex Injection Line Rotating Adapter Recalled Due to O-Ring Defect

    Smiths Medical is recalling Medex injection line rotating adapters due to a manufacturing defect where the O-ring inner diameter may be oversized, potentially causing medication leaks during infusion.

    Product
    Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2024·2024-01-24

    Medex LOGICAL CATH LAB KIT Recalled for Oversized O-Ring Defect

    Smiths Medical is recalling the Medex LOGICAL CATH LAB KIT due to a manufacturing defect where the O-ring inner diameter may be oversized, affecting seal integrity and potentially leading to medication under-infusion.

    Product
    Medex LOGICAL CATH LAB KIT, List Number M20754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0726-2024·2024-01-24

    PRIMA TT Shoulder Implant Baseplates Recalled for Manufacturing Defect Risk

    PRIMA TT shoulder implant baseplates are being recalled by Limacorporate due to manufacturing defects in the baseplate peripheral holes that could cause the implant to loosen or the screw to move.

    Product
    PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0747-2024·2024-01-24

    Smiths Medical Injection Line Rotating Adapters Recalled for Seal Defect

    Smiths Medical is recalling specific injection line rotating adapters due to a manufacturing defect causing oversized O-rings that may lead to inadequate seal integrity and medication under-infusion.

    Product
    48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0255-2024·2024-01-24

    Secret Dry Spray Antiperspirant Recalled Due to Manufacturing Facility Contamination Risk

    The FDA is recalling certain lots of Secret Dry Spray Antiperspirant due to a manufacturing facility deviation and potential benzene contamination. All affected lots expire through September 2023.

    Product
    Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-383-10, UPC: 0 37000 72986 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0221-2024·2024-01-17

    FDA Recalls Desloratadine Tablets Due to Manufacturing Defect

    Lupin Pharmaceuticals is recalling Desloratadine 5mg tablets distributed nationwide because N-Nitroso impurity levels exceeded acceptable limits. Affected lots expire in January 2024.

    Product
    DESLORATADINE — DESLORATADINE (DESLORATADINE)
    Category
    Drug
    Distribution
    Distributed nationwide