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.

351–375 of 1441

  • HighFDA (Devices)·Z-1342-2024·2024-03-27

    Surgical Guidewire Introducer Sheath Recalled for Internal Manufacturing Defects

    Angiodynamics vascular guidewire introducers (600 units) may have internal defects preventing proper function during surgery. Defects could cause procedure delays and require device exchange.

    Product
    MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
    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
  • 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-1348-2024·2024-03-27

    Guidewire Introducer Sheath Recalled for Internal Lumen Voids

    Angiodynamics is recalling 39 units of MINI STICK MAX vascular guidewire introducers due to voids in the sheath hub that may prevent guidewire passage during surgery, potentially delaying the procedure.

    Product
    MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1321-2024·2024-03-27

    Preat Nobel RP Titanium Abutment Blank Recalled for Manufacturing Defect

    Preat Corp is recalling 561 units of RP Titanium Abutment Blanks due to a manufacturing defect where the screw seat location may be too high, resulting in shortened screw engagement into the implant.

    Product
    Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2024·2024-03-27

    Angiodynamics Guidewire Introducer Recall Due to Manufacturing Defect

    Angiodynamics recalls approximately 5,840 guidewire introducers with manufacturing defects that may prevent proper guidewire insertion during vascular procedures. The defect could cause procedural delays requiring equipment exchange.

    Product
    MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1322-2024·2024-03-27

    Dental Implant Impression Coping Recalled for Manufacturing Defect

    Thommen Medical AG is recalling impression coping units because the internal canal depth was not manufactured according to specifications, preventing firm connection to the dental implant. The product was distributed in Ohio and Kentucky.

    Product
    impression coping, repositionable, short, screw-retained, PF 4.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2024·2024-03-27

    Vascular Guidewire Introducer Recalled Due to Internal Hub Defect

    A vascular guidewire introducer is recalled because internal voids in the hub may prevent proper guidewire passage, potentially delaying surgical procedures.

    Product
    MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2024·2024-03-27

    Guidewire Introducer Recalled for Manufacturing Defect Affecting Device Function

    Angiodynamics is recalling 58 units of its MINI STICK MAX guidewire introducer due to voids in the internal lumen that may prevent proper guidewire passage. Users may experience procedural delay requiring device exchange.

    Product
    MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
    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-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
  • 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-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
  • 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…
    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 (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
  • 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 (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
  • 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
  • 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
  • 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
  • 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