The Recall Desk

Hazard

Coating Defect recalls

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

What the numbers show

Total
14
Critical
1
Severe
0
Most recent
2025-10-22

Of the 14 coating defect recalls we have scored against our rubric, 1 (7%) 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 coating 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.

1–14 of 14

  • CriticalFDA (Devices)·Z-0043-2026·2025-10-22

    Thoracic endovascular grafts recalled over coating scrapings that may embolize

    Cook Medical is recalling 695 Zenith Alpha 2 Thoracic Endovascular Grafts because affected devices may contain PTFE coating scrapings that could be released during deployment.

    Product
    Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-173 ZTA2-P-42-173-W ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-1
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Devices)·Z-2620-2025·2025-10-01

    Surgical light systems recalled over powder coating stress lines and chipping

    Chromophare surgical light systems and an associated upgrade kit are being recalled because stress lines in the powder coating indicate that the coating can chip.

    Product
    Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1741-2025·2025-05-21

    Halyard CHRIST SUTURE KIT surgical needles coating defect recall

    AVID Medical is recalling Halyard CHRIST SUTURE KIT units due to a raw material issue in the needle coating that may cause silicone to be removed during use, potentially affecting surgical performance.

    Product
    Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1742-2025·2025-05-21

    Halyard SUTURE PACK CABG Cardiovascular Kit Needle Coating Issue

    AVID Medical is recalling Halyard SUTURE PACK CABG Cardiovascular Procedure Convenience Kits due to a raw material defect in the surgical needle coating that may reduce needle performance or cause coating removal during use.

    Product
    Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2024·2024-06-12

    Synchro2 Guidewires: PTFE coating damage from improper backloading technique

    Stryker Neurovascular is recalling certain lots of Synchro2 Guidewires due to PTFE coating damage caused by backloading through an introducer accessory with manufacturing variations. Affected users should discontinue the backloading technique.

    Product
    The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2022·2022-08-03

    HammerTube 2.75mm Implant Recalled for Missing Titanium Plasma Coating

    Paragon 28 recalls HammerTube implants missing their titanium plasma coating. Affected implants were distributed to facilities in Alabama, California, Georgia, Illinois, and Kentucky.

    Product
    HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2022·2022-03-02

    Shoulder Implant Stem Recalled for Defective Coating Adhesion

    Biomet is recalling Comprehensive Shoulder System Mini Humeral Stems due to defective porous plasma coating adhesion. Internal testing indicated affected parts may lack sufficient coating strength.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2022·2022-03-02

    Biomet Shoulder Stem Implants Recalled for Coating Adhesion Defect

    Biomet is recalling certain shoulder stem implants due to potential insufficient adhesion strength in the porous plasma coating. An improper rework process may have compromised the coating's integrity.

    Product
    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0357-2020·2019-11-20

    TriMed Hex Driver Recall Due to Epoxy Coating Defect

    TriMed Inc. is recalling 467 Hex Drivers because the epoxy coating may pop off. The recall covers units distributed nationwide and to several foreign countries.

    Product
    TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0328-2017·2016-11-16

    SentreHeart Recalls FindrWIRZ Guidewire Systems Due to Coating Defects

    SentreHeart Inc is recalling FindrWIRZ Guidewire Systems because the lubricious coating delaminated and flaked off three units in Germany.

    Product
    FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1047-2014·2014-03-05

    Medline Recalls Angio Pack #2 Surgical Kits Due to Coating Defect

    Medline Industries is recalling 768 units of Angio Pack #2 surgical kits because a guidewire component has a potential for its coating to flake off.

    Product
    ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2014·2014-03-05

    Medline Recalls Surgical Kits with Potential Coating Defect on Guidewires

    Medline Industries is recalling 10 surgical kits containing guidewires with a potential coating defect. The kits were distributed to specific US states.

    Product
    STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1053-2014·2014-03-05

    Medline Recalls Sterile Sample Cath Lab Packs Due to Coating Defect

    Medline Industries is recalling 10 units of Sterile Sample Cath Lab Packs because a guidewire component has a potential for its coating to flake off.

    Product
    STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide