The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

24326–24350 of 50442

  • HighFDA (Devices)·Z-0530-2020·2019-12-04

    Zimmer Biomet Recalls Ball Nose Guide Wires Due to Cleaning Issues

    Zimmer Biomet is recalling Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2020·2019-12-04

    Boston Scientific Recalls Rebel Monorail Coronary Stent Systems

    Boston Scientific is recalling 14,145 Rebel Monorail PtCr Coronary Stent Systems because they may be missing a hydrophilic coating step.

    Product
    Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2020·2019-12-04

    GN Hearing Recalls Behind-the-Ear Hearing Aids Due to Software Bug

    GN Hearing is recalling 590 behind-the-Ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.

    Product
    Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2020·2019-12-04

    Zimmer Biomet Recalls HHR Tess Cleats Due to Bacterial Endotoxin

    Zimmer Biomet is recalling Comprehensive HHR Tess Cleats because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2020·2019-12-04

    Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Devices Due to Bent Probe Risk

    Beckman Coulter is recalling UniCel DxH Slidemaker Stainer devices because a bent dispense probe may cause cell carryover, leading to erroneous lab results and potential inappropriate patient treatment.

    Product
    UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2020·2019-12-04

    Abbott Recalls Alinity c Carbon Dioxide Reagent Kits Due to CO2 Absorption

    Abbott is recalling Alinity c Carbon Dioxide Reagent Kits because atmospheric carbon dioxide can be absorbed into the reagent, potentially causing incorrect test results.

    Product
    Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2020·2019-12-04

    Endotronix Recalls myCordella Patient Kits for Unexpected Power-Downs

    Endotronix is recalling 58 myCordella Patient Kits because the devices have been reported to power down without user interaction.

    Product
    myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.
    Category
    Medical Device
    Distribution
    3 states
  • HighNHTSA·19V864000·2019-12-04

    Ford Recalls 2017-2019 Super Duty Trucks for Tailgate Latch Defect

    Ford is recalling 2017-2019 Super Duty trucks because water intrusion may cause the tailgate to open unexpectedly, creating a road hazard.

    Product
    FORD — FORD F-350 SD, F-250 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2020·2019-12-04

    Zimmer Biomet Recalls Comprehensive RS Cleat CAP Due to Contamination

    Zimmer Biomet is recalling Comprehensive RS Cleat CAP devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.

    Product
    Comprehensive RS Cleat CAP, Item No. 110300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2020·2019-12-04

    Zimmer Biomet Recalls Copeland HA Resurfacing Heads Due to Cleaning Issues

    Zimmer Biomet is recalling Copeland HA Resurfacing Heads because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2020·2019-12-04

    Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris

    Zimmer Biomet is recalling specific Aim/Art Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2020·2019-12-04

    Boston Scientific Recalls Emerge Monorail PTCA Catheters Due to Coating Defect

    Boston Scientific is recalling Emerge Monorail PTCA Dilatation Catheters because they may lack a required hydrophilic coating. The recall covers 14,145 devices distributed nationwide and in Canada.

    Product
    Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2020·2019-12-04

    Becton Dickinson Recalls Site~Rite 8 Ultrasound Systems Due to Battery Indicator Defect

    Becton Dickinson is recalling 2,215 Site~Rite 8 Ultrasound Systems because the battery indicator may falsely show charge, causing abrupt shutdowns without warning.

    Product
    Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2020·2019-12-04

    Zimmer Biomet Recalls Total Elbow Replacement Devices Due to Cleaning Issues

    Zimmer Biomet is recalling specific total elbow replacement devices because elevated levels of bacterial endotoxin and residual debris remain on them due to a cleaning issue.

    Product
    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0194-2020·2019-12-04

    Kroger Mushroom Stir Fry Blend Recalled for Listeria Risk

    Renaissance Food Group is recalling 1,839 units of Kroger Mushroom Stir Fry Blend in Washington and Oregon due to potential Listeria monocytogenes contamination.

    Product
    Kroger Mushroom Stir Fry Blend 10 oz. UPC 82676618482
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·19V858000·2019-12-03

    Moto Guzzi Recalls 2020 V85 TT Motorcycles for Footrest Defect

    Piaggio is recalling 399 2020 Moto Guzzi V85 TT motorcycles because footrest mounting clips may break, causing the footrest to fall off and create a road hazard.

    Product
    MOTO GUZZI — MOTO GUZZI V85 TT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19E082000·2019-12-03

    Zamzow Aero Easy Cover tarping pawl assembly recall issued

    Zamzow is recalling one Aero Easy Cover tarping pawl assembly because a missing weld may cause the part to separate, increasing injury risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V857000·2019-12-02

    Moto Guzzi Recalls 2020 V85 TT Motorcycles for Oil Leak Hazard

    Piaggio is recalling 2020 Moto Guzzi V85 TT motorcycles because a final drive seal may leak oil onto the rear tire, increasing crash risk.

    Product
    MOTO GUZZI — MOTO GUZZI V85 TT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·118-2019·2019-11-29

    Blue Grass Quality Meats Recalls Pork and Turkey Products for Undeclared Soy

    Blue Grass Quality Meats is recalling approximately 121,083 pounds of pork bacon and ready-to-eat turkey products because they contain undeclared soy, a known allergen.

    Product
    Blue Grass Provisions Co. Inc. — Blue Grass Quality Meats Recalls Pork and Turkey Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    5 states
  • 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 (Food)·F-0307-2020·2019-11-27

    Russ Davis Wholesale Recalls Steamed Vegetables for Listeria Risk

    Russ Davis Wholesale is recalling steamed broccoli, cauliflower, and carrots with butter due to potential Listeria monocytogenes contamination.

    Product
    Broccoli, Cauliflower & Carrots with Butter - 18 oz, and Broccoli & Cauliflower with Butter - 16 oz; packaged with a small generic clear label on Q & E Steamer bag.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0256-2020·2019-11-27

    Mann Packing Recalls Cauliflower Florets Due to Listeria Contamination

    Mann Packing Company is recalling various cauliflower floret products due to a positive test for Listeria monocytogenes.

    Product
    HEB Cauliflower Florets 10 oz. UPC: 41220322787 Mann's Organic Cauliflower Florets: 10 oz. UPC: 716519059995 Mann's Family Favorites Cauliflower Florets 10 oz. UPC: 716519014031 Mann's Brand: 3 lbs. UPC: 10716519040037 - Food Service 3 lbs. UPC: 10716519040013…
    Category
    Food
    Distribution
    0 states