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.

Which agencies issued them

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.

1076–1100 of 1434

  • HighFDA (Devices)·Z-0733-2019·2019-01-23

    Waldemar Link LINK STEM Reconstruction Prosthesis Recalled for Depth Defect

    Waldemar Link is recalling 11 LINK STEM Reconstruction Prostheses because a manufacturing defect prevents the reaming guide from reaching the intended depth, which may lead to incorrect surgical positioning.

    Product
    LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0664-2019·2019-01-02

    Abbott Alinity i TSH Reagent Kit Recalled for Manufacturing Defect

    Abbott is recalling Alinity i TSH Reagent Kits due to a manufacturing issue that may damage bottle necks, potentially causing reagent loading failures on the instrument.

    Product
    Alinity i TSH Reagent Kit, List Number 07P4830
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0665-2019·2019-01-02

    Abbott Alinity i Free T4 Reagent Kit Recalled for Manufacturing Defect

    Abbott is recalling 294 units of Alinity i Free T4 Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument loading failures.

    Product
    Alinity i Free T4 Reagent Kit, List Number 07P7030
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-0655-2019·2018-12-26

    Nidek RT-5100 Refractor Recalled for Incomplete Lens Bonding

    Nidek Inc. is recalling 85 RT-5100 Refractors distributed in Florida because the lens bonding was incomplete.

    Product
    RT-5100 Refractor, a component of the Epic-5100 System.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0582-2019·2018-12-19

    Medtronic HeartWare HVAD Battery Charger Recalled for Incorrect Inductors

    Heartware, Inc. is recalling 2,031 HVAD System Battery Charger units because they were manufactured with incorrect inductors. The recall covers units distributed in the US and multiple international countries.

    Product
    Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an altern
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0292-2019·2018-12-19

    CAO Group Recalls BeeGentle Topical Anesthetic Due to cGMP Violations

    CAO Group, Inc. is recalling BeeGentle Honey Flavored Topical Anesthetic because of current Good Manufacturing Practice (cGMP) violations found during a recent FDA inspection.

    Product
    BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Me
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0553-2019·2018-12-12

    Zimmer Biomet Recalls 20mm Compress Device Short Anchor Plug

    Zimmer Biomet is recalling 6 units of the 20mm Compress Device Short Anchor Plug due to potential metal burrs that may prevent proper insertion of drill and transverse pins.

    Product
    Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously fai
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0528-2019·2018-12-12

    Becton Dickinson Recalls Trypticase Soy Agar Plates Due to Growth Inhibition

    Becton Dickinson is recalling 54,300 plates of Trypticase Soy Agar with 5% Sheep Blood because a manufacturing error inhibited the growth of Gram-negative organisms.

    Product
    BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0512-2019·2018-12-05

    Smiths Medical Recalls Medex High Pressure Stopcocks Due to Leak Risk

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Stopcocks because an inner body defect may cause the device to leak.

    Product
    Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0200-2019·2018-10-31

    Smith+Nephew Legion AP Femoral Cutting Block Recalled for Oversized Spring

    Smith & Nephew is recalling one lot of Legion AP femoral cutting blocks, size 6, because they were manufactured with an oversized spring.

    Product
    Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0083-2019·2018-10-31

    Lannett Recalls Hydroxyzine Hydrochloride Syrup Due to Impurities

    Lannett Company is recalling 8,324 bottles of Hydroxyzine Hydrochloride Syrup because cleaning procedures caused out-of-specification results for unknown impurities.

    Product
    HYDROXYZINE HYDROCHLORIDE — HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2019·2018-10-24

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 241 units of ECMO Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length labeling.

    Product
    ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2019·2018-10-24

    OriGen Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 73 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length labeling.

    Product
    Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0058-2019·2018-10-24

    FDA Recalls Best Choice Nasal Spray Due to Manufacturing Quality Issues

    Product Quest Manufacturing LLC is recalling 3,600 bottles of Best Choice Nasal Spray because they were manufactured under conditions that could impact product quality.

    Product
    Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 59895 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies

    OriGen Biomedical is recalling 452 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and incorrect tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2019·2018-10-24

    OriGen Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 169 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0068-2019·2018-10-10

    Surge Medical Sales Recalls Retrograde Cardioplegia Cannula Due to Stylet Error

    Surge Medical Sales is recalling 35 units of the Retrograde Cardioplegia Cannula because they were built with a rigid stylet instead of a flexible one.

    Product
    Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-3264-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling 6 units of HipLOC System 140° Plates due to an undersized bore that prevents the lag screw from fitting through the barrel.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3254-2018·2018-10-03

    Intuitive Surgical Recalls da Vinci Redundant Medical Grade Power Supply Units

    Intuitive Surgical is recalling specific da Vinci Surgical System power supply units that were manufactured incorrectly and may fail during use.

    Product
    da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasiv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3263-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling 44 units of the HipLOC Hip Fracture Fixation System due to an undersized bore that may prevent the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fix
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3211-2018·2018-09-26

    Accuray Recalls CyberKnife Calibration Film Due to Dimensional Inaccuracy

    Accuray is recalling 259 units of Ashland Box Film Ball Cube II calibration film because manufacturing defects may cause up to 0.5 mm of positional inaccuracy in CyberKnife systems.

    Product
    Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2877-2018·2018-08-29

    TriMed Ulnar Osteotomy Compression Plate Recalled for Manufacturing Defect

    TriMed Inc. is recalling 722 Ulnar Osteotomy Compression Plates because instrument holes are located on the wrong side of the plate.

    Product
    Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2876-2018·2018-08-29

    Zimmer Biomet Recalls Persona Partial Knee System Spacer Block Alignment Tower

    Zimmer Biomet is recalling 385 units of the Persona Partial Knee System Spacer Block Alignment Tower because an undersized mating feature could cause device connection issues and minor surgical delays.

    Product
    Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2794-2018·2018-08-22

    Mako Surgical Recalls Rio System Irrigation Clips Due to Tolerance Issues

    Mako Surgical Corporation is voluntarily recalling 10,606 Rio System Irrigation Clips because they are out of tolerance. The recall covers units distributed worldwide.

    Product
    Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and ref
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2742-2018·2018-08-22

    Merit Medical Systems Recalls 1mL Medallion Syringes Due to Plunger Defect

    Merit Medical Systems is recalling 22,234 units of 1mL Medallion Syringes due to a manufacturing defect in the plunger tip.

    Product
    1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide