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

28601–28625 of 40357

  • HighFDA (Devices)·Z-0306-2017·2016-11-02

    Hospira Symbiq Infuser Recall for Potential White Screen Error

    Hospira is recalling Symbiq Two Channel Infusers because a white screen error during KVO titration could delay therapy and cause significant injury.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2017·2016-11-02

    Lumenis Recalls FemTouch Delivery System Due to Ineffective Cleaning Instructions

    Lumenis Limited is recalling 69 units of the FemTouch delivery system because the provided cleaning instructions may be ineffective for fully assembled devices, posing a risk of cross-contamination.

    Product
    FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0297-2017·2016-11-02

    AccessClosure Recalls PAXWIRE Occlusion Balloon System Due to Removal Risk

    AccessClosure, Inc. is voluntarily recalling the PAXWIRE Occlusion Balloon System because the device may be removed without a vascular sheath in place.

    Product
    The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0302-2017·2016-11-02

    TEM Systems Recalls ex-TEM Assay Reagents Due to Low Vial Levels

    TEM Systems Inc is recalling ex-TEM Assay reagents for the ROTEM delta system because customers reported low or empty vials.

    Product
    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2017·2016-11-02

    Siemens CMV IgM Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 CMV IgM Assay kits due to reported increased imprecision and high coefficient of variation results.

    Product
    IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2017·2016-11-02

    Pentax Video Gastroscope Recall for Updated Operation and Reprocessing Instructions

    Pentax of America Inc is recalling video gastroscopes to provide customers with the most recent Operation and Reprocessing Instructions (IFUs).

    Product
    Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2017·2016-11-02

    Zimmer Biomet Recalls Patellofemoral Joint Prosthesis Milling Handpieces

    Zimmer Biomet is recalling 703 Patellofemoral Joint Prosthesis Milling Handpieces because they may be inoperable due to lack of preventative maintenance, potentially delaying surgery.

    Product
    Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2017·2016-11-02

    Keystone Dental PrimaConnex Straight Implant Recall Due to Cover Screw Mismatch

    Keystone Dental Inc. is recalling 55 units of PrimaConnex Straight Implants because small diameter cover screws were packaged with regular diameter implants.

    Product
    Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0298-2017·2016-11-02

    TZ Medical Recalls Mis-Labeled Neptune Plus Hemostatic Pads

    TZ Medical is recalling Neptune Plus hemostatic pads because the labels incorrectly state they include an antimicrobial barrier.

    Product
    Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0319-2017·2016-11-02

    Siemens CMV IgM Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling IMMULITE CMV IgM Assay kits due to reported increases in imprecision and high coefficient of variation (CV) values.

    Product
    IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0312-2017·2016-11-02

    Becton Dickinson Recalls PhoenixSpec AP Calibrator Due to Labeling Error

    Becton Dickinson is recalling 94 units of PhoenixSpec AP Calibrator because the expiration date year is incorrectly labeled on the kit.

    Product
    PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Devices)·Z-0313-2017·2016-11-02

    Ortho-Clinical Diagnostics Recalls VITROS HBsAg Controls Due to Performance Drift

    Ortho-Clinical Diagnostics is recalling VITROS HBsAg Controls because signal/cutoff results may increase during the 5-day reconstituted timeframe, potentially affecting performance monitoring.

    Product
    VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0311-2017·2016-11-02

    Becton Dickinson Recalls PhoenixSpec Calibrator Kits Due to Labeling Error

    Becton Dickinson is recalling specific lots of BBL PhoenixSpec Calibrator kits because the kits are labeled with an incorrect expiration year, although the individual tubes have correct dates.

    Product
    PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0004-2017·2016-10-26

    Leonhard Lang Recalls Skintact Defibrillation Electrodes Due to Connection Delay

    Leonhard Lang is recalling Skintact DF29N defibrillation electrodes because they may not connect to Welch Allyn AED 10 devices promptly, delaying life-saving treatment.

    Product
    Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0119-2017·2016-10-26

    Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect

    Synergetics Inc is recalling 72 units of 25 gauge VersaVit 2.0 Core Essentials Procedure Packs because the vitrectomy cutters do not operate within correct pressure pulse specifications.

    Product
    25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0231-2017·2016-10-26

    Windstone Medical Recalls Major General Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 852 Major General Packs because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0260-2017·2016-10-26

    Windstone Medical Packaging Recalls Peri Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 115 Peri Kits (PSS1037) because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0054-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass RX Dual Access Catheters Due to Manufacturing Defect

    Vascular Solutions is recalling Twin-Pass RX Dual Access Catheters because excess manufacturing material may remain at the tip or within the distal lumen.

    Product
    Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0141-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0274-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0053-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass Catheters Due to Manufacturing Material

    Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the tip or in the distal lumen.

    Product
    Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0005-2017·2016-10-26

    Heartware Ventricular Assist System Controller Recall for Loose Connector Ports

    Heartware, Inc. is recalling Ventricular Assist System Controllers due to loose connector ports. The recall affects 4,235 units worldwide, including 7,272 in the U.S.

    Product
    HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0055-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass Dual Access Catheters Due to Manufacturing Residue

    Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the catheter tip or within the distal rapid exchange lumen.

    Product
    Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0044-2017·2016-10-26

    Teleflex Medical Recalls Willy Rusch Tracheostomy Tube Sets

    Teleflex Medical is recalling Willy Rusch Tracheostomy Tube Sets because the connector may disconnect from the tube during use.

    Product
    Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
    Category
    Medical Device
    Distribution
    Distributed nationwide