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.

1276–1300 of 1441

  • SevereFDA (Devices)·Z-1494-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 233 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2015·2015-04-29

    Churchill Medical Systems Recalls 7-Inch High Pressure Extension Sets

    Churchill Medical Systems is recalling 6,850 units of 7-inch Standard Bore High Pressure Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.

    Product
    7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2015·2015-04-29

    Churchill Medical 4-inch Microbore T-Port Set Recalled for Leaking Risk

    Churchill Medical Systems is recalling 450 units of 4-inch Microbore T-Port Sets due to a potential leak caused by insufficient bonding between components.

    Product
    4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1475-2015·2015-04-29

    Churchill Medical Systems Recalls 7-inch High Pressure Extension Sets

    Churchill Medical Systems is recalling 6,850 units of 7-inch Standard Bore High Pressure Extension Sets due to a potential leak caused by insufficient bonding.

    Product
    7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1485-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 102 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2015·2015-04-29

    Churchill Medical Systems Recalls 7-Inch High Pressure Sets Due to Leaking Risk

    Churchill Medical Systems is recalling 129,500 units of 7-inch High Pressure Sets with Bionector due to a potential for leaking caused by insufficient bonding.

    Product
    7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1360-2015·2015-04-08

    Zimmer Recalls Persona Anterior Referencing Sizers Due to Specification Nonconformance

    Zimmer, Inc. is voluntarily recalling 22 lots of Persona Anterior Referencing Sizers with Locking Boom because the devices do not conform to print specifications.

    Product
    Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer…
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Devices)·Z-1249-2015·2015-03-18

    Microport Evolution Tibial Base Recalled for Casting Tool Defect

    Microport Orthopedics is recalling 17 units of the Evolution Tibial Base knee prosthesis component due to a casting tool issue causing varying retaining wall thickness and keel offset.

    Product
    EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1246-2015·2015-03-11

    DePuy Orthopaedics Recalls Partially Agglomerated SMARTSET GHV Bone Cement

    DePuy Orthopaedics is recalling one lot of SMARTSET GHV Gentamicin Bone Cement because it is partially agglomerated, which may cause surgical delays.

    Product
    SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1219-2015·2015-03-11

    Zimmer Segmental System Hip Stem Recalled for Coating Defect

    Zimmer, Inc. is recalling specific Zimmer Segmental System hip stems because the PMMA coating may be missing or not meet specifications.

    Product
    Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1066-2015·2015-02-18

    Stryker Recalls System 6 Aseptic Housings Due to Weld Defect

    Stryker is recalling 399 System 6 Aseptic Housings because a failed test revealed a lack of a continual weld. Customers are instructed to return the product to Stryker.

    Product
    System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2015·2015-02-18

    Biomet Spine Recalls Timberline Cranial Caudal and Posterior Blades

    Biomet Spine, LLC is recalling Timberline Cranial Caudal and Posterior Blades due to an oversize set screw hex feature.

    Product
    Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0970-2015·2015-01-21

    Stelkast Recalls EXp Tibial Inserts Due to Manufacturing Defect

    Stelkast Co is recalling 553 EXp Tibial Inserts because a missing lead-in radius may make it difficult to lock the inserts into tibial trays.

    Product
    EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous…
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-0990-2015·2015-01-21

    Med Tec Recalls Short Wool Wrist Loops for Shoulder Retractors

    Med Tec Inc is recalling specific wool wrist loops for shoulder retractors because they were manufactured 7cm shorter than specifications.

    Product
    Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx The devise is intended to pull patients shoulders down for clearance when treating lateral fields to…
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0989-2015·2015-01-21

    Med Tec Recalls Short Wool Wrist Loops for Shoulder Retractors

    Med Tec Inc is recalling 11 units of a wool wrist loop component for shoulder retractors because the items were manufactured 7cm shorter than specifications.

    Product
    Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0900-2015·2015-01-07

    Zimmer Recalls Osteobond Bone Cement Due to Adhesive Transfer Defect

    Zimmer, Inc. is recalling 40 units of Osteobond Bone Cement because samples failed to meet visual requirements for adhesive transfer between the Tyvek lid and cavity.

    Product
    Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0875-2015·2014-12-31

    Zimmer Recalls Trilogy Fiber Metal Acetabular Shell Due to Thread Defect

    Zimmer Manufacturing B.V. is recalling 68 units of Trilogy Fiber Metal Acetabular Shells because the polar-hole threads were found to be undersized, preventing proper attachment to surgical instruments.

    Product
    Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0589-2015·2014-12-17

    Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper

    Smith & Nephew is recalling 24 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.

    Product
    LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0522-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0513-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0514-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0517-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states