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.

1301–1325 of 1434

  • 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-0418-2015·2014-12-03

    Materialise Recalls Zimmer Patient Specific Instrument PERSONA CR Pin Guides

    Materialise USA LLC is recalling specific Zimmer Patient Specific Instrument PERSONA CR Pin Guides because the packaging contained incorrect components and one guide exceeded size specifications.

    Product
    Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0226-2015·2014-12-03

    Synthes Recalls Titanium Polyaxial Reduction Heads for Spine Screws

    Synthes (USA) Products LLC is recalling 24 Titanium Polyaxial Reduction Heads for Matrix Spine Screws because the inner diameter may not have been machined to the correct specification.

    Product
    Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0527-2015·2014-11-26

    Formulations For Life Recalls Vision Assure Extra Strength Vision Formula

    Formulations For Life is recalling Vision Assure Extra Strength Vision Formula dietary supplements due to lack of Good Manufacturing Practices and misbranding.

    Product
    FORMULATIONS FOR LIFE Vision Assure Extra Strength Vision Formula DIETARY SUPPLEMENT, 1) 60 VEGETARIAN CAPSULES, 2) 120 VEGETARIAN CAPSULES. Distributed by: Formulations for Life Hauppauge, New York 11788 USA.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0197-2015·2014-11-19

    Integra Titan Reverse Shoulder System Cutting Templates Recalled for Manufacturing Error

    Integra LifeSciences Corp. is recalling 12 units of Reverse Shoulder System cutting templates because the threaded handle was welded backwards, resulting in an incorrect cutting angle.

    Product
    Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the hume
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0134-2015·2014-11-05

    Cooper Vision Recalls ProClear Toric Contact Lenses for Axis Defect

    Cooper Vision is recalling ProClear Toric contact lenses because routine quality monitoring found that some lots were manufactured with the cylinder axis outside allowable specifications.

    Product
    ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0021-2015·2014-10-15

    Biomet Compress Face Reamer Recalled for Missing Helix Angle

    Biomet, Inc. is recalling four Compress Face Reamer units because they were missing the required 4x21 degree helix angle.

    Product
    Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2604-2014·2014-09-17

    Wright Medical Recalls CLAW II Orthopedic Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling 178 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.

    Product
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2573-2014·2014-09-10

    Pioneer Surgical Technology Recalls Streamline CT Set Screws

    Pioneer Surgical Technology is recalling 11 sets of Streamline CT Cervico-Thoracic System set screws because some thread profiles were not within specifications.

    Product
    STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2258-2014·2014-08-27

    Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

    Smith & Nephew is recalling 601 units of Trigen Intertan nails because a manufacturing error caused the proximal lag screw hole to be positioned incorrectly.

    Product
    TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 13MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling specific Uni*Fuse Infusion Systems because they may contain a guidewire that is too long. The recall covers 36 units distributed in the US and internationally.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2242-2014·2014-08-27

    Biomet Recalls Vanguard 360 Femoral Boss Reamers Due to Sizing Defect

    Biomet is recalling 461 Vanguard 360 Femoral Boss Reamers because they were manufactured oversized and may not fit into mating components.

    Product
    Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2172-2014·2014-08-20

    Medtronic Recalls Ascenda Intrathecal Catheters Due to Retainer Ring Defect

    Medtronic is recalling specific lots of Ascenda Intrathecal Catheters and Revision Kits because a retainer ring component may not meet specifications, risking catheter disconnection.

    Product
    Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2014·2014-07-30

    Exactech Recalls NOVATION Femoral Stems Lacking Plasma Coating

    Exactech is recalling 10 NOVATION Femoral Stems because they lack the specified plasma coating. The devices were distributed worldwide.

    Product
    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2103-2014·2014-07-30

    Terumo TenderFlow Pediatric Venous Cannulae Recalled for Loose Fiber Particulate

    Terumo CVS is recalling specific lots of TenderFlow Pediatric Venous Cannulae due to loose fiber particulate exceeding specifications found during inspection.

    Product
    Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2095-2014·2014-07-30

    Terumo Recalls Sarns Aortic Arch Cannulas Due to Loose Fiber Particulate

    Terumo CVS is recalling 120 units of Sarns Flexible Aortic Arch Cannulas because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1992-2014·2014-07-16

    Amerigel Wound Dressing Recalled for Manufacturing Process Concerns

    Kova Laboratories is recalling Amerigel Wound Dressing 1 oz. tubes because they may not have been manufactured pursuant to a validated process protocol and CGMP.

    Product
    Amerigel Wound Dressing 1 oz. tube
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1931-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1935-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1938-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1933-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1936-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1937-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide