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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

38301–38325 of 40449

  • ModerateFDA (Devices)·Z-1503-2013·2013-06-12

    Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach

    Stryker is recalling 2,000 units of T4 Toga surgical drapes due to potential sterile barrier breaches identified in accelerated aging tests.

    Product
    Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2013·2013-06-12

    Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns

    Stryker is recalling 5,000 units of T4 Toga Zipper products due to potential sterile barrier breaches identified in accelerated aging tests.

    Product
    Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1515-2013·2013-06-12

    Siemens ADVIA Centaur iPTH Calibrator Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.

    Product
    ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1494-2013·2013-06-12

    Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T4 Toga pullovers because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1479-2013·2013-06-12

    Bion Enterprises IgG FITC Conjugate Recalled for Incorrect Expiration Date

    Bion Enterprises is recalling 504 units of IgG FITC Conjugate because the labeled expiration date is one year too long.

    Product
    Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1441-2013·2013-06-12

    Optovue iVue Software Recall Due to Inconsistent Color Display

    Optovue, Inc. is recalling iVue software versions 3.0 and 3.1 because color displays for Ganglion Cell Complex thickness are inconsistent across different report types.

    Product
    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1477-2013·2013-06-12

    Bion Enterprises IgG Conjugate Recalled for Incorrect Expiration Date Labeling

    Bion Enterprises Ltd is recalling 207 units of IgG Conjugate because the labeled expiration date is one year too long.

    Product
    Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1478-2013·2013-06-12

    Bion Enterprises IgM Conjugate Recalled for Incorrect Expiration Date Labeling

    Bion Enterprises is recalling 201 units of IgM Conjugate because the labeled expiration date is one year too long.

    Product
    Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1372-2013·2013-06-05

    AsthmaNefrin Starter Kit Recalled for Choking Hazard

    Nephron Pharmaceuticals is recalling AsthmaNefrin Starter Kits because a component may dislodge and cause a choking hazard.

    Product
    AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1371-2013·2013-06-05

    FDA Recalls EZ Breathe Atomizers Due to Choking Hazard

    Nephron Pharmaceuticals is recalling EZ Breathe Atomizers because a component may dislodge, creating a choking hazard.

    Product
    EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1373-2013·2013-06-05

    Nephron Pharmaceuticals Recalls EZ Breathe Medication Cups Due to Choking Hazard

    Nephron Pharmaceuticals is recalling EZ Breathe Medication Cups because a component may dislodge, creating a potential choking hazard.

    Product
    EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2013·2013-06-05

    Zimmer Recalls NEXGEN Complete Knee Solution Tibial Drills

    Zimmer, Inc. is recalling 69 units of NEXGEN Complete Knee Solution Tibial Drills because the outside diameter may be oversized, preventing them from passing through the drill guide.

    Product
    NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1406-2013·2013-06-05

    AngioDynamics Recalls VenaCure EVLT NeverTouch Procedure Kits Due to Sizing Error

    AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because the packaged micro Introducer may be the wrong French size.

    Product
    AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2013·2013-06-05

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

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

    Product
    8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Recalled for Catheter Breakage Risk

    Stryker Orthobiologics is recalling 17 units of the Aliquot Plunger, 8", due to reported catheter breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2013·2013-06-05

    Stryker Orthobiologics Aliquot Beveled Needle Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 12 units of the Aliquot Beveled Needle due to reported catheter breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2013·2013-06-05

    AngioDynamics Recalls Micro Introducer Kits Due to Potential Size Mismatch

    AngioDynamics is recalling Micro Introducer Kits because the packaged sheath or dilator may be the incorrect French size.

    Product
    AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2013·2013-06-05

    RayStation Therapy Treatment Planning System Recalled for Image Offset Errors

    RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System software versions 2.0, 2.5, and 3.0 because imported medical images may be offset by one pixel, potentially leading to incorrect dose calculations.

    Product
    RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1404-2013·2013-06-05

    Canon RK-F2 Ref-Keratometer Recalled for Abnormal Refractive Power Readings

    Canon Inc. is recalling 384 RK-F2 Ref-Keratometers because the device may display abnormal refractive power values in approximately 5% of cases.

    Product
    Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 414 Aliquot Plungers because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2013·2013-06-05

    Fisher & Paykel Recalls ICON CPAP Units Due to Power Issue

    Fisher & Paykel Healthcare is recalling 1,407 ICON CPAP units because they may become inoperable, interrupting treatment for obstructive sleep apnea.

    Product
    Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2013·2013-06-05

    Heart Sync Recalls Radiotransparent Defibrillation Electrodes Due to Equipment Damage

    Heart Sync, Inc. is recalling Vermed Radiotransparent Defibrillation Electrodes because a supplier defect may prevent the device from delivering appropriate electrical shocks to patients.

    Product
    Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac…
    Category
    Medical Device
    Distribution
    13 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
  • HighFDA (Devices)·Z-1434-2013·2013-06-05

    Heart Sync C100-Physio Defibrillation Electrodes Recalled for Potential Energy Delivery Failure

    Heart Sync, Inc. is recalling C100-Physio defibrillation electrodes due to a supplier issue that may prevent the device from delivering appropriate electrical shocks.

    Product
    Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1438-2013·2013-06-05

    TZ Medical Recalls Defibrillation Electrodes Due to Defective White Wire

    TZ Medical Inc. is recalling P-211-M1 and P-214-M1 defibrillation electrodes because they may contain a defective white wire on the connector assembly.

    Product
    adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing…
    Category
    Medical Device
    Distribution
    Distributed nationwide