The Recall Desk

Hazard

Defective Manufacturing recalls

12 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
12
Critical
0
Severe
0
Most recent
2023-11-01

Of the 12 defective manufacturing recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 defective manufacturing 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.

1–12 of 12

  • HighFDA (Devices)·Z-0068-2024·2023-11-01

    OMTMO Ovulation Test Strips Recalled for Unverified Manufacturing Quality

    Universal Meditech Inc. is recalling 40,000 OMTMO ovulation test strips because the manufacturer is closing operations and cannot provide required manufacturing and quality documentation.

    Product
    OMTMO One Step Ovulation (LH) Test Strips REF 200-07
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1085-2021·2021-02-17

    Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes

    Cardinal Health is recalling isolation gowns and lab coats due to potential defects like rips, holes, and open seams that may compromise barrier protection.

    Product
    Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1081-2021·2021-02-17

    Cardinal Health Recalls ChemoPlus Drug Spill Kits Due to Gown Defects

    Cardinal Health is recalling ChemoPlus Drug Spill Kits because the included gowns may have rips, holes, or foreign material.

    Product
    ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2020·2019-10-09

    Paltop Advanced Plus Dental Implant Recall for Surface Topography Defects

    Paltop Advanced Dental Solutions is recalling 167 dental implants because surface micro/nano topography may be inconsistent. The recall covers units distributed to 16 states.

    Product
    Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2153-2019·2019-08-14

    SenTec Standard Starter Set Recalled for Potential Electrolyte Deficiency

    SenTec AG is recalling Standard Starter Sets due to a risk of missing or reduced electrolyte application during the membrane change procedure.

    Product
    SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2019·2019-08-14

    SenTec Membrane Changer Insert Recalled for Electrolyte Application Defect

    SenTec AG is recalling Membrane Changer Inserts due to a 5% chance of missing or reduced electrolyte application during sensor changes.

    Product
    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1668-2016·2016-05-25

    Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating

    The Anspach Effort, Inc. is recalling 27 Otologic Curved Micro Diamond Ball Burrs because they may be missing the diamond coating or be the incorrect size.

    Product
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0321-2016·2015-12-02

    Medtronic Sofamor Danek Recalls Midas Rex Legend Wire Pass Tools

    Medtronic Sofamor Danek is recalling 9 Midas Rex Legend wire pass tools because the wire pass hole is missing. The tools were distributed in California, New York, Texas, and Belgium.

    Product
    Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2738-2015·2015-09-16

    Trilliant Gridlock Screw Driver Bits Recalled for Out-of-Specification Dimensions

    Trilliant Surgical Ltd. is recalling 108 units of Gridlock Screw Driver Bits because they are out of specification, which may cause screw heads to strip during surgery.

    Product
    2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1662-2015·2015-06-03

    Siemens Immulite 2000 Water Feed Kit Recall for Defective Bottle Assemblies

    Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Water Feed Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1773-2014·2014-06-18

    Stryker Wire Pass Drill Recalled for Missing Notches

    Stryker is recalling 246 sterile 1.5mm Wire Pass Drills because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0911-2013·2013-03-13

    BD Vacutainer Plus Plasma Separator Tubes Recalled for Deformed Reservoirs

    Becton Dickinson is recalling BD Vacutainer Plus Plasma Separator Tubes due to deformed tube reservoirs reported in two customer complaints.

    Product
    BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for speci
    Category
    Medical Device
    Distribution
    Distributed nationwide