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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18826–18850 of 40124

  • ModerateFDA (Devices)·Z-0579-2020·2019-12-04

    Boston Scientific Recalls NC Emerge Monorail PTCA Catheters for Coating Defect

    Boston Scientific is recalling NC Emerge Monorail PTCA Dilatation Catheters because they may be missing a hydrophilic coating step during manufacturing.

    Product
    NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0537-2020·2019-12-04

    Helena Laboratories Recalls Collagen Reagent Due to Potential Contamination

    Helena Laboratories is recalling Collagen Reagent kits because vials may contain particulate matter or microbial growth.

    Product
    Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0548-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 109 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0556-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 139 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0514-2020·2019-12-04

    Stryker X-Change Medial Wall Mesh Small Recall for Incorrect Contents

    Howmedica Osteonics Corp. is recalling 40 units of Stryker X-Change Medial Wall Mesh Small (6-Petal) because boxes contain the 4-Petal version instead.

    Product
    Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0558-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0557-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling

    Boston Scientific is recalling 271 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0544-2020·2019-12-04

    Abbott Alinity i Accessory Kit Recalled for Potential Sensor Cracks

    Abbott is recalling Alinity i accessory kits because environmental stress may cause cracks in the bulk solution level sensor.

    Product
    Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0555-2020·2019-12-04

    Boston Scientific Recalls Pancreatic Stents with Incorrect Shelf Life Labeling

    Boston Scientific is recalling Advanix Pancreatic Stents labeled with a 36-month shelf life instead of the approved 18-month duration.

    Product
    Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0578-2020·2019-12-04

    Boston Scientific Recalls Guidezilla II Catheters Due to Missing Coating

    Boston Scientific is recalling Guidezilla II Guide Extension Catheters because they may lack a hydrophilic coating, potentially affecting device performance.

    Product
    Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0582-2020·2019-12-04

    Bard PowerPort isp M.R.I. Implantable Port Recalled for Incorrect Sheath Size

    Bard Peripheral Vascular Inc is recalling 900 units of PowerPort isp M.R.I. Implantable Ports because they were packaged with the incorrect introducer sheath size.

    Product
    PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0546-2020·2019-12-04

    Spineart JULIET Ti OL Cage Recalled for Incorrect Inner Blister Label

    Spineart SA is recalling 14 JULIET Ti OL cages due to a mismatch between the inner blister pack label and the external box label.

    Product
    Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0576-2020·2019-12-04

    Spectranetics AngioSculpt Balloon Catheter Recalled for Incorrect Outer Carton

    Spectranetics Corporation is recalling three AngioSculpt PTCA Scoring Balloon Catheters because the incorrect outer carton box was used for the product.

    Product
    Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0420-2020·2019-11-27

    Edwards Lifesciences Recalls EZ Glide Aortic Cannula Due to Connector Separation Risk

    Edwards Lifesciences is recalling EZ Glide Aortic Cannulae because the cannula may separate from its connector, potentially causing significant blood loss during surgery.

    Product
    EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0498-2020·2019-11-27

    Philips HeartStart XL+ Defibrillator Recall Due to Switch Failure

    Philips is recalling HeartStart XL+ Defibrillators because a faulty switch may cause the device to fail or deliver incorrect shock energy.

    Product
    HeartStart XL+ Defibrillator/Monitor, Model 861290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0510-2020·2019-11-27

    Applied Medical Recalls GelPOINT Path Transanal Procedural Packs Due to Insulation Shift

    Applied Medical Resources Corp is recalling GelPOINT Path Transanal Procedural Packs because the tip insulation on the electrosurgical probes may shift unintentionally.

    Product
    GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2020·2019-11-27

    Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

    Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 951 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are used in angiographic procedures.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect

    Cook Inc. is recalling 791 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide