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.

326–350 of 1434

  • HighFDA (Devices)·Z-1622-2024·2024-05-01

    TRIDENTII HEMI hip implant recalled for acetabular shell manufacturing defect

    Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER48D hip implant because the acetabular shell may have excessive deburring, resulting in a smooth surface on the shell edge.

    Product
    TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1631-2024·2024-05-01

    Hip replacement acetabular shell recalled for excessive deburring

    Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER58F hip replacement acetabular shells due to excessive deburring. The manufacturing defect affects units distributed nationwide and internationally.

    Product
    TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2024·2024-05-01

    Hip replacement acetabular shells recalled for deburring defect

    Howmedica is recalling hip replacement acetabular shells that may have excessive deburring, resulting in a smooth surface on the shell edge. The recall affects devices distributed nationwide and internationally.

    Product
    TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1625-2024·2024-05-01

    TRIDENTII HEMI Hip Implant Acetabular Shell Deburring Defect Recall

    Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER54E hip implant due to excessive deburring on the acetabular shell edge that may affect implant performance. The recall involves 225 units distributed nationwide and internationally.

    Product
    TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1627-2024·2024-05-01

    Hip Implant Acetabular Shell May Have Excessive Deburring Manufacturing Defect

    Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER66H hip implants because the acetabular shell may have excessive deburring, creating a smooth surface on the edge of the shell.

    Product
    TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2024·2024-05-01

    Vanguard Knee System Tibial Bearing Recalled for Manufacturing Damage

    Biomet is recalling the Vanguard Knee System AS Tibial Bearing (Model 189082) due to possible damage during manufacturing. Affected units were distributed worldwide including the United States.

    Product
    Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2024·2024-05-01

    NexGen CR-Flex Femoral Components Recalled for Bonding Defect

    Zimmer is recalling 5,546 units of NexGen CR-Flex Femoral Components due to a manufacturing defect where the fiber metal pad fails to bond properly to the substrate. Patients with these implants should contact their healthcare provider.

    Product
    NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2024·2024-05-01

    Hip Implant Acetabular Shell Recalled for Manufacturing Defect

    Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER50D hip implant shells due to excessive deburring that may create a smooth edge, potentially affecting implant fit. Affected units were distributed nationwide and internationally.

    Product
    TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0465-2024·2024-05-01

    FUL-GLO Fluorescein Sodium Ophthalmic Strips Recalled for API Manufacturing Defect

    Nomax Inc recalls FUL-GLO Fluorescein Sodium Ophthalmic Strips (Lot 14776) nationwide due to API manufacturing specification failures. The active ingredient was not manufactured to current USP standards regarding unspecified impurities.

    Product
    FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0438-2024·2024-04-17

    FDA Recalls Lansoprazole Delayed-Release Capsules for Manufacturing Practice Deviations

    NATCO Pharma Limited is voluntarily recalling 30 bottles of Lansoprazole 15 mg delayed-release capsules due to Current Good Manufacturing Practice deviations. The product was distributed nationwide in the United States.

    Product
    Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2024·2024-04-10

    Medline Pediatric Magill Catheter Recalled for Weak Seal Risk

    Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.

    Product
    Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2024·2024-04-10

    X-Guide Handpiece Adaptor Sleeve defect affects fit on dental handpiece

    The X-Guide Handpiece Adaptor Sleeve 1 may have a manufacturing defect causing incorrect geometry that prevents proper fit on dental handpieces. Approximately 88 units are affected.

    Product
    X-Guide Handpiece Adaptor Sleeve 1, Model P010701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1459-2024·2024-04-10

    Medline Blood Pressure Units Recalled for Manufacturing Specification Non-Compliance

    Medline Industries is recalling 74,339 blood pressure units nationwide (models MDS4001, MDS4001LA, MDS4001PLUS) due to manufacturing non-compliance with specifications.

    Product
    Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2024·2024-04-10

    Abbott ARCHITECT STAT Myoglobin Reagent Kit recalled due to manufacturing defect

    Abbott is recalling certain myoglobin test kits because of manufacturing defects that could lead to incorrect results and delayed heart attack diagnosis.

    Product
    ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1393-2024·2024-04-10

    X-Guide Handpiece Adaptor Sleeve 3 Manufacturing Defect Recall

    X-NAV Technologies is recalling the X-Guide Handpiece Adaptor Sleeve 3 due to a manufacturing defect causing incorrect geometry that prevents proper fit. The recall affects 154 units distributed worldwide.

    Product
    X-Guide Handpiece Adaptor Sleeve 3, Model P010727
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1399-2024·2024-04-10

    BD Phoenix Yeast ID Panel Recalled for Incorrect Substrate Placement

    Becton Dickinson recalls BD Phoenix Yeast ID Panel units (Lot 3312180) due to misplaced esculin substrate that triggers system abortion. No injuries reported.

    Product
    BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1302-2024·2024-04-03

    Boston Scientific steerable sheath devices recalled due to manufacturing defect risk

    Boston Scientific is recalling 461 POLARSHEATH Steerable Sheath devices due to a manufacturing tooling error that may cause inner sheath delamination and potential fragment release during medical procedures.

    Product
    Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1396-2024·2024-04-03

    Certain OptiCross Coronary Imaging Catheters recalled for manufacturing defect

    Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.

    Product
    OptiCross Coronary Imaging Catheter, REF H749518080120
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-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-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-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-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
  • 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