The Recall Desk

Hazard

Surgical Instrument 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
0
Severe
0
Most recent
2024-11-20

Of the 14 surgical instrument defect 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 surgical instrument 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

  • HighFDA (Devices)·Z-0450-2025·2024-11-20

    Surgical kits recalled for potentially detachable metal flakes

    AVID Medical is recalling Halyard VA lumbar laminectomy surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site.

    Product
    Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0451-2025·2024-11-20

    Surgical forceps and clamps recalled due to potential metal flake contamination

    AVID Medical is recalling Halyard ENT surgical convenience kits due to potential metal flakes from forceps and clamps that could enter a patient's surgical site. Metal flakes may cause local or foreign body reactions during surgery.

    Product
    Halyard ENT - Medical convenience kits Model Number: VMED011-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 units distributed nationwide and internationally.

    Product
    Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2659-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled for Reduced Sharpness in Eye Surgery

    Alcon Research LLC is recalling 2,520 CLEARCUT HP2 DB ophthalmic knives due to increased reports of reduced sharpness. The affected lot 164RY1 was distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2646-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled by Alcon Due to Sharpness Defects

    Alcon is recalling 3,721 units of its 25GA Valved Entry System ophthalmic knives due to complaint reports about sharpness. The devices were distributed nationwide and internationally to 50+ countries.

    Product
    Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2661-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling ophthalmic surgical knives (model 8065990002) due to increased complaint reports regarding sharpness. Approximately 9,384 units have been distributed domestically and internationally.

    Product
    Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2658-2023·2023-10-11

    HeartMate Left Ventricular Assist Device Coring Knife Sharpness Defect

    The Apical Coring Knife in HeartMate 3 Left Ventricular Assist System kits may be inadequately sharp, potentially extending surgical implantation time. Thoratec has distributed 2,681 affected units worldwide.

    Product
    Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1395-2023·2023-04-26

    Instrument Kit Drill Guides Have Incorrect Depth Range

    GEO Instrument Kits for EPS Plates contain drill guides marked with an incorrect depth range (30mm-60mm instead of 10mm-40mm), which could affect surgical implant placement.

    Product
    GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1406-2022·2022-07-27

    Spinal Surgery Instrument Recall: LEFT CORONAL BENDER May Deform Implants

    Aesculap Implant Systems LLC is recalling the LEFT CORONAL BENDER (TEK1939) surgical instrument used in spinal procedures because it may deform implants when used with spinal system devices.

    Product
    LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1391-2022·2022-07-27

    Surgical knee implant instrument key may become nonfunctional during assembly

    Aesculap is recalling the ENDURO SPECIAL KEY TIB.LOCK.RING (product code NP462R) used in knee replacement surgery because the key pins may be damaged during assembly, causing the instrument to become nonfunctional.

    Product
    ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2022·2021-11-24

    Beaver Xstar Crescent Knife surgical blades recalled for specification mismatch

    Beaver Visitec is recalling CustomEyes surgical kits where Crescent Knives contain bevel-up blades instead of the specified bevel-down blades. The specification error could affect surgical precision during cataract procedures.

    Product
    bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2016·2015-12-16

    Zimmer Persona EM Distal Rod Recalled for Ratchet Latching Defect

    Zimmer, Inc. is recalling 156 Persona EM Distal Rods because the ratchet teeth may not latch onto the rod. The defect could affect the stability of the surgical instrument during use.

    Product
    Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2082-2014·2014-07-30

    DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty

    DePuy Orthopaedics is recalling 814 RECLAIM Taper Protector Sleeves because the product can be difficult to remove from the Distal Stem.

    Product
    RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1433-2013·2013-06-05

    Intuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Cautery Plug Defect

    Intuitive Surgical is recalling 8mm Fenestrated Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.

    Product
    8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide