The Recall Desk

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
2026-09-09

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.

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.

351–375 of 1434

  • HighFDA (Devices)·Z-1343-2024·2024-03-27

    Vascular Guidewire Introducer Sheath Recalled for Internal Hub Defect

    Angiodynamics recalls 130 MINI STICK MAX guidewire introducers due to hub voids that may prevent guidewire passage during vascular procedures. No injuries reported.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2024·2024-03-27

    MINI STICK MAX guidewire introducer defect may prevent sheath passage during procedures

    Angiodynamics is recalling MINI STICK MAX guidewire introducers (155 units) due to manufacturing defects in the sheath hub that may prevent guidewire passage.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2024·2024-03-27

    Vascular guidewire introducer recalled for manufacturing defect

    Angiodynamics recalls MINI STICK MAX vascular guidewire introducers due to internal lumen defects that may prevent the guidewire from passing through during surgery, potentially requiring device exchange.

    Product
    MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1344-2024·2024-03-27

    Guidewire Introducer Sheath with Manufacturing Defect Recalled by Angiodynamics

    Angiodynamics is recalling MINI STICK MAX guidewire introducer sheaths due to manufacturing defects that may prevent guidewire passage. The defect may cause procedural delays requiring equipment exchange during vascular interventions.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1336-2024·2024-03-27

    FDA Recalls Vascular Guidewire Introducer Due to Manufacturing Defect

    Angiodynamics is recalling 959 units of MINI STICK MAX guidewire introducers due to voids in the sheath hub that may prevent proper guidewire placement. Users may experience procedure delays and need to exchange equipment.

    Product
    MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1346-2024·2024-03-27

    Guidewire Introducer Sheath from Angiodynamics Recalled for Manufacturing Defect

    Angiodynamics is recalling 65 units of its MINI STICK MAX guidewire introducer sheath due to manufacturing defects that may prevent guidewires from passing through during surgical procedures.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1339-2024·2024-03-27

    Angiodynamics surgical guidewire recalled for manufacturing defect

    Angiodynamics is recalling 5,176 units of MINI STICK MAX guidewires due to manufacturing voids that prevent passage through the introducer during surgery. Surgeons may need to exchange the sheath to complete procedures.

    Product
    MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1335-2024·2024-03-27

    Angiodynamics Guidewire Introducer Devices Recalled for Manufacturing Defects

    Angiodynamics recalls MINI STICK MAX guidewire introducer devices due to manufacturing defects in the internal lumen that may prevent guidewire passage and delay surgical procedures.

    Product
    MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2024·2024-03-20

    CARTO VIZIGO Guiding Sheath Recalled for Manufacturing Validation Issue

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths after inadvertently mixing unvalidated devices into production. The recall affects 853 units distributed nationwide.

    Product
    CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0366-2024·2024-03-13

    Methylprednisolone Acetate Injectable Suspension Recalled for Failed Dissolution

    Eugia US LLC recalls methylprednisolone acetate injection due to failed dissolution specifications. Affected states: Ohio, Tennessee, Louisiana, and Mississippi.

    Product
    METHYLPREDNISOLONE ACETATE — METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1063-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for ventilation failure risk

    Vyaire Medical is recalling 4,572 units of AirLife Adult Manual Resuscitators due to defective components that may cause improper ventilation or complete ventilation failure, potentially resulting in hypoventilation, hypoxia, or death.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0359-2024·2024-03-06

    7 Eleven Hand Sanitizer Gel recalled for manufacturing facility deficiencies

    Seatex LLC is recalling 1,282 cases of 7 Eleven Hand Sanitizer Gel due to manufacturing facility deficiencies found during FDA inspection. The product was distributed nationwide.

    Product
    7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2024·2024-03-06

    Colonoscope Model CF-Q180AL Recalled Due to Missing Protective Adhesive

    Olympus is recalling two colonoscopes (Model CF-Q180AL, serial numbers 2602060 and 2603763) due to missing protective adhesive that normally guards against vibration, temperature changes, and shock loads.

    Product
    Colonoscope, Model Number CF-Q180AL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2024·2024-03-06

    Colonoscope Model CF-H180AL Recalled Due to Missing Protective Adhesive

    Olympus is recalling 36 colonoscopes with specific serial numbers that lack a protective adhesive, risking device failure if exposed to vibration, temperature changes, or shock loads.

    Product
    Colonoscope, Model Number CF-H180AL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0360-2024·2024-03-06

    PROBLEND Hand Sanitizer Recalled Due to Manufacturing Deficiencies

    Seatex LLC is recalling PROBLEND Hand Sanitizer (Lot 266029) nationwide due to manufacturing deficiencies identified during FDA inspection.

    Product
    PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0358-2024·2024-03-06

    7 Eleven Hand Sanitizer Recalled for Manufacturing Deficiencies

    A hand sanitizer distributed to 7-Eleven gas stations nationwide is being recalled due to manufacturing deficiencies identified during an FDA inspection. The affected product is lot 251176, distributed in the United States and Puerto Rico.

    Product
    7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-1148-2024·2024-02-28

    Patterson Procedure Earloop Masks Recalled Due to Non-Validated Production Equipment

    Patterson Procedure Earloop Masks (ASTM Level 3, blue) are being recalled because units were produced on non-validated equipment. The recall affects 180 cases with lot numbers 2339 and 2342, distributed across six states.

    Product
    PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2024·2024-02-28

    Ionolux dental cement recalled for manufacturing defect affecting curing

    Ionolux dental cement capsules may contain incorrect plungers that prevent proper curing. Affected batches distributed in the US and internationally should not be used.

    Product
    Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; 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-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-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