The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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34051–34075 of 40325

  • HighFDA (Devices)·Z-0589-2015·2014-12-17

    Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper

    Smith & Nephew is recalling 24 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.

    Product
    LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2015·2014-12-17

    Abbott Healon EndoCoat Ophthalmic Device Recalled for Finger Grip Defect

    Abbott Medical Optics is recalling Healon EndoCoat ophthalmic devices because the finger grip can dislodge, potentially causing eye trauma during surgery.

    Product
    Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0565-2015·2014-12-17

    Pfm Medical Recalls ASEPT Peritoneal Drainage Systems for Bacterial Endotoxin

    Pfm Medical is recalling 83 units of the ASEPT Peritoneal Drainage System because the devices may exceed USP limits for bacterial endotoxin.

    Product
    ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2015·2014-12-17

    Alcon Single-Use Iris Bipolar Forceps Recalled for Lack of Sterilization

    Alcon Research, Ltd. is recalling single-use iris bipolar forceps labeled as sterile but not sterilized prior to shipment.

    Product
    Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2015·2014-12-17

    Pfm Medical Recalls ASEPT Pleural Drainage Systems for Bacterial Endotoxin

    Pfm Medical is recalling ASEPT Pleural Drainage Systems because they may exceed USP limits for bacterial endotoxin. The recall affects 120 units distributed in the US and internationally.

    Product
    ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2015·2014-12-17

    PFM Medical Recalls Veta Peritoneal Catheter Kits for Bacterial Endotoxin

    PFM Medical is recalling Veta Peritoneal Catheter Kits because they may exceed USP limits for bacterial endotoxin.

    Product
    Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0563-2015·2014-12-17

    PFM Medical Recalls Micro Introducer Kits Due to Bacterial Endotoxin Limits

    PFM Medical is recalling 100 units of Micro Introducer Kits because they may exceed USP limits for bacterial endotoxin. The devices are used for introducing therapeutic devices like PICCs.

    Product
    Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0579-2015·2014-12-17

    ArthroCare Medical Recalls Ambient HipVac and KVac Wands for Sterile Barrier Breach

    ArthroCare Medical Corporation is recalling 23,119 Ambient HipVac and KVac wands due to a potential breach of the sterile barrier caused by defective product trays.

    Product
    Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2015·2014-12-17

    Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negative Risk

    Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement because it may cause false negative Legionella test results.

    Product
    Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2015·2014-12-17

    Snug Seat Recalls Crocodile Size 3 Walking Aids Due to Bolt Failure

    Snug Seat Inc is recalling 726 Crocodile size 3 walking aids because bolts securing the handles could break, causing the handles to dislodge.

    Product
    Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0522-2015·2014-12-17

    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- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0536-2015·2014-12-17

    Instrumed Recalls External Vein Strippers Due to Regulatory Non-Compliance

    Instrumed International is withdrawing 479 external vein strippers because the company did not market them before 1976, failing to meet FDA pre-amendment requirements.

    Product
    An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0528-2015·2014-12-17

    Concentric Medical Recalls Trevo Pro 4 Stent Retrievers Due to Labeling Error

    Concentric Medical is recalling 10 units of Trevo Pro 4 Stent Retrievers because they were shipped with non-U.S. instructions for use that did not align with U.S. indications.

    Product
    Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0539-2015·2014-12-17

    Instrumed Recalls Manual Trephines for Regulatory Compliance

    Instrumed International is withdrawing 74 manual trephines from the market because the devices do not meet FDA requirements for pre-amendment marketing.

    Product
    Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0513-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0525-2015·2014-12-17

    Concentric Medical Recalls Distal Access Catheters Due to Incorrect Labeling

    Concentric Medical is recalling 87 Distal Access Catheters because they were shipped with Directions for Use containing instructions for aspiration, which are only approved outside the US.

    Product
    Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the…
    Category
    Medical Device
    Distribution
    17 states
  • 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-0532-2015·2014-12-17

    Instrumed Recalls Uterine Tenaculum Hooks for Regulatory Compliance

    Instrumed International is withdrawing 26 uterine tenaculum hooks because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0517-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0511-2015·2014-12-17

    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 validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0581-2015·2014-12-17

    Conformis iTotal CR G2 Knee Replacement System Recalled for Incorrect Serial Numbers

    ConforMIS, Inc. is recalling one unit of the iTotal CR G2 Knee Replacement System due to an incorrect serial number on the tibial insert packaging.

    Product
    Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0543-2015·2014-12-17

    Instrumed Recalls Cushing Burr Instruments for Regulatory Non-Compliance

    Instrumed International is withdrawing Cushing burrs because the company failed to meet FDA requirements for marketing pre-amendment devices.

    Product
    Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0512-2015·2014-12-17

    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- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0569-2015·2014-12-17

    Stryker 1488 HD 3-Chip Camera Recall for Colored Screen Image

    Stryker Endoscopy is recalling 1,965 1488 HD 3-Chip Cameras because a colored screen image may occur in certain operating room environments.

    Product
    1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy…
    Category
    Medical Device
    Distribution
    Distributed nationwide