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.

11001–11025 of 22147

  • HighNHTSA·22V209000·2024-07-03

    Keystone Cougar travel trailers recalled for outrigger tire clearance defect

    Keystone is recalling 2019-2022 Cougar travel trailers due to improper outrigger clearance that may allow tires to contact the outrigger. Damaged tires can fail and cause loss of vehicle control and increased crash risk.

    Product
    KEYSTONE — 2019 KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2024·2024-07-03

    NovaGuide 2 Ultrasound System Recall Due to Grounding Cable Disconnection Risk

    NovaGuide 2 Traditional Ultrasound systems may have grounding cables that can be inadvertently disconnected during use, creating risk of electrical shock and equipment malfunction. Twenty-eight systems have been distributed nationwide.

    Product
    NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2024·2024-07-03

    Stryker Hoffman LRF Wire Tensioner Adjustment Ring May Become Loose

    Stryker is recalling 39 Hoffman LRF Wire Tensioner devices because the adjustment ring may loosen, preventing proper tension setting. No injuries reported.

    Product
    Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2024·2024-07-03

    Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalls 46 PRIMO MRI VR SureScan implantable cardioverter defibrillators due to a manufacturing defect. Weld cracks identified during manufacturing quality checks could cause device failure.

    Product
    PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2024·2024-07-03

    Endoscopic Kittner Surgical Instrument Recalled for Sterile Barrier Defect

    ASPEN SURGICAL is recalling 1,900 units of the Endoscopic Kittner Blunt Dissecting Instrument (Model KT-9101) due to a potential defect in the sterile barrier seal.

    Product
    Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1400-2024·2024-07-03

    Wakefield Bacon, Egg & Cheese Bagels recalled for possible Listeria contamination

    Classic Delight LLC is recalling 2,311 cases of Wakefield Bacon, Egg & Cheese Bagels (Item 514711) due to possible Listeria monocytogenes contamination. The affected product was distributed across 14 states.

    Product
    (Item 514711) Wakefield Bacon, Egg & Cheese Bagel
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1426-2024·2024-07-03

    Chocolate Chunk Cookie Mix Recalled for Undeclared Coconut Allergen

    Penguin Natural Foods is recalling 'THE PERFECT CHOCOLATE CHUNK COOKIE MIX Cravings by Chrissy Teigen' because the product contains undeclared coconut. Consumers with coconut allergies face a serious health risk.

    Product
    "THE PERFECT CHOCOLATE CHUNK COOKIE MIX Cravings by Chrissy Teigen NET WT. 15.76 OZ (447g)" Packaged in a beige cardboard box, with green lettering
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2205-2024·2024-07-03

    Medtronic MIRRO MRI ICD devices recalled for manufacturing weld crack defect

    Medtronic recalls 13 MIRRO MRI VR SureScan implantable cardioverter defibrillators (ICDs) due to a manufacturing weld crack. The defect was identified and caused device failure during the manufacturing leak check quality control test.

    Product
    MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2024·2024-07-03

    Medtronic COBALT VR MRI SureScan implantable defibrillators recalled for manufacturing defect

    Medtronic is recalling 4 COBALT VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing defect involving a weld crack identified during quality control testing.

    Product
    COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2024·2024-07-03

    Implantable Cardioverter Defibrillator Recalled Due to Manufacturing Weld Defect

    Medtronic is recalling 26 MIRRO MRI DR SureScan Implantable Cardioverter Defibrillators due to a manufacturing defect involving a weld crack that could affect device function.

    Product
    MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1405-2024·2024-07-03

    Wakefield Ham, Egg & Cheese Muffins Recalled for Possible Listeria Contamination

    Classic Delight LLC is recalling 1,366 cases of Wakefield Ham, Egg & Cheese Muffins due to possible Listeria monocytogenes contamination. The affected products were distributed across 14 states.

    Product
    (Item 806604) Wakefield Ham, Egg & Cheese Muffin
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0564-2024·2024-07-03

    Buprenorphine Injection Recalled Due to Incomplete Seal Integrity Issue

    Pfizer is recalling specific lots of Buprenorphine Hydrochloride Injection due to potential incomplete crimp seals that could compromise product sterility. Patients using affected lots should consult their healthcare provider.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V207000·2024-07-03

    2022 Triumph Speed Triple RS Motorcycle Rear Brake Disc Bolts May Loosen

    Triumph is recalling 2022 Speed Triple RS and Speed Triple RR motorcycles because rear brake disc bolts may loosen, potentially preventing the wheel from rotating freely and increasing crash risk.

    Product
    TRIUMPH — 2022 TRIUMPH SPEED TRIPLE RS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1423-2024·2024-07-03

    Fresh Catch Inc. Yellowfin Tuna Recalled for High Histamine Levels

    Fresh Catch Inc. is recalling Yellowfin Tuna for high histamine levels. No illnesses have been reported.

    Product
    Fresh Catch Inc. Yellowfin Tuna, 1 loin per case packaged in carboard boxes with keep refrigerated label
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2175-2024·2024-07-03

    Endoscopic Vessel Harvesting System Recalled Due to Potential Cautery Malfunction

    Maquet Cardiovascular recalls VasoView HemoPro 2 vessel harvesting systems due to potential fluid ingress that may prevent or unintentionally activate cautery function. The recall affects 430,037 units distributed worldwide.

    Product
    The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2024·2024-07-03

    Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalled 14 COBALT HF QUAD CRT-D MRI SureScan implantable defibrillators due to a weld crack manufacturing defect detected during quality control testing.

    Product
    COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2216-2024·2024-07-03

    NovaGuide 2 Ultrasound Systems Recalled for Electrical Shock Risk

    FDA is recalling 45 NovaGuide 2 Intelligent Ultrasound systems due to a defective grounding cable that could become disconnected and cause electrical shock, electrical interference, or equipment malfunction.

    Product
    NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2186-2024·2024-07-03

    Siemens Multix TOP X-ray Table Recalled Due to Fire Risk

    Siemens is recalling 3 Multix TOP I PRO radiographic X-ray tables due to a short circuit in the Touch Display power supply unit that may cause overheating and fire.

    Product
    MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1396-2024·2024-07-03

    Classic Delight Breaded Chicken Waffle Recalled for Possible Listeria Contamination

    Classic Delight Breaded Chicken Waffle (Item 7626) for institutional use is being recalled due to possible contamination with Listeria monocytogenes. The recall affects 644 cases distributed to institutions in 14 states.

    Product
    (Item 7626) Classic Delight Breaded Chicken Waffle - INSTITUTIONAL USE ONLY
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2211-2024·2024-07-03

    Medtronic ICD Implants Recalled for Manufacturing Weld Crack Defects

    Medtronic recalls 9 units of CROME VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality control leak testing.

    Product
    CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2024·2024-07-03

    Sight OLO CBC Test Kit Lot Recalled for Bacterial Contamination

    One lot of Sight OLO CBC Test Kit is being recalled due to bacterial contamination that causes artificially elevated platelet counts. The affected kits may produce inaccurate test results.

    Product
    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2024·2024-07-03

    Patient Monitors May Fail to Display Vitals After Power Loss

    GE Healthcare is recalling certain CARESCAPE Canvas patient monitors that may fail to display vital signs after a power loss if the CPU battery has been replaced. This could delay recognition of changes in patient condition.

    Product
    CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1398-2024·2024-07-03

    Wakefield Southern Chicken Biscuit recalled for possible Listeria contamination

    Classic Delight LLC is recalling Wakefield Southern Chicken Biscuit (Item 176594) due to possible Listeria monocytogenes contamination. The product was distributed in 14 states with multiple affected lot numbers.

    Product
    (Item 176594) Wakefield Southern Chicken Biscuit
    Category
    Food
    Distribution
    0 states