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.

32576–32600 of 50502

  • HighFDA (Devices)·Z-1759-2017·2017-04-19

    ConMed Recalls Sterile Handpiece Sheaths Packaged as Non-Sterile

    ConMed is recalling sterile handpiece sheaths that were incorrectly packaged with non-sterile units. This error could lead to the use of non-sterile sheaths in medical procedures.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2017·2017-04-19

    Nihon Kohden Bedside Monitor Recall for Pause Function Defect

    Nihon Kohden America Inc is recalling 654 bedside monitors because the pause function on central monitors fails to automatically resume when connected to specific Life Scope G9 units.

    Product
    Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1790-2017·2017-04-19

    Windstone Eye Cataract Kits Recalled for Sterile Packaging Compromise

    Windstone Medical Packaging is recalling Eye Cataract Packs because the sterile packaging of the included eye pad may be compromised.

    Product
    Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1763-2017·2017-04-19

    Roche Recalls Cobas 8100 Modules Due to Potential Sample Spillage

    Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a software issue can cause rack crashes and sample spillage, posing a risk of exposure to infectious material.

    Product
    Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-1937-2017·2017-04-19

    Dolcetta Maple-Pepper Caramels Recalled for Undeclared Soy and Milk Allergens

    Dolcetta Artisan Sweets is recalling Maple-Pepper Caramels because they contain undeclared soy lecithin and milk. The product was distributed in Oregon and Washington.

    Product
    Maple-Pepper Caramels are caramels with maple syrup and black pepper, 3.9 oz (110g), individually wrapped in cellophane and then wrapped in a paper box.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1774-2017·2017-04-19

    Draegar Medical Systems Recalls Kappa and Scio Patient Monitors

    Draegar Medical Systems is recalling Kappa and Scio patient monitors because a low oxygen alarm may fail to sound when oxygen levels drop below the set limit.

    Product
    Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are intended to be used in the environment where patient care is provided by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2017·2017-04-19

    Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Display Error

    Merge Healthcare is recalling iConnect Enterprise Archive software because an error message can prevent users from viewing prior studies. The recall affects 333 sites nationwide and internationally.

    Product
    iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2017·2017-04-19

    Aesculap Minop InVent 30 Trocar System Recalled for Sharp Edges

    Aesculap Implant Systems LLC is recalling the Minop InVent 30 Trocar System because sharp edges may abrade insulation during use.

    Product
    AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·17V258000·2017-04-18

    Volvo Recalls 2015-2017 VHD Trucks for Incorrect Axle Weight Labels

    Volvo is recalling 2015-2017 VHD trucks because the Gross Axle Weight Rating on the certification label may be incorrect, which could lead to vehicle overloading.

    Product
    VOLVO — VOLVO VHD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17132·2017-04-13

    Polaris Recalls Ranger 900 Vehicles Due to Fire and Burn Hazards

    Polaris is recalling about 51,000 Ranger 900 recreational off-highway vehicles because a heat shield can fall off, posing fire and burn hazards.

    Product
    Polaris Ranger 900 recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17131·2017-04-13

    Bosch Recalls Roof-Mounted Solar Panels Due To Fire Hazard

    Bosch Solar Services is recalling about 28,000 roof-mounted solar panels because they can overheat and pose a fire risk. No injuries have been reported.

    Product
    Roof-mounted Bosch solar panels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17740·2017-04-13

    Polaris Recalls Sportsman ATVs Due to Electronic Power Steering Malfunction

    Polaris is recalling about 3,800 model year 2017 Sportsman and Scrambler ATVs because the electronic power steering unit can malfunction, posing a crash hazard.

    Product
    Sportsman 450, 570, 850, 1000 and Scrambler 1000 all-terrain vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2017·2017-04-12

    Philips BrightView X Gamma Camera Recall for Brake Hub Assembly Error

    Philips is recalling BrightView X 3/4 gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated…
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Food)·F-1734-2107·2017-04-12

    Nestle Butterfinger Peanut Butter Crisp Candy Bar Recall for Plastic Pieces

    Nestle USA is recalling Butterfinger Peanut Butter Crisp Chocolate Candy Bars because they may contain small rigid plastic pieces that could cause cuts or lacerations during consumption.

    Product
    Nestle Butterfinger Peanut Butter Crisp Chocolate Candy Bar in 3-pack SharePack (2.01 oz); and in 6-pack Snack Tray (4.02oz)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1877-2017·2017-04-12

    IKEA Recalls Choklad Ljus Milk Chocolate for Undeclared Allergens

    IKEA is recalling Choklad Ljus Milk Chocolate bars due to undeclared milk, hazelnut, and almond ingredients.

    Product
    Choklad Ljus Milk Chocolate Net Wt 3.5 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-1873-2017·2017-04-12

    IKEA Recalls Dark Chocolate Bars for Undeclared Milk, Almond, and Hazelnut

    IKEA is recalling specific dark chocolate bars because they contain undeclared milk, almond, and hazelnut. Consumers with allergies to these ingredients should not eat the product.

    Product
    Dark Chocolate bars Choklad Mork Dark Chocolate, Net Wt. 3.5 OZ. AND Chokland Mork Dark Chocolate 70%, Net Wt. 3.5 OZ. Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-1878-2017·2017-04-12

    IKEA Recalls Chocolate Products for Undeclared Milk, Almond, and Hazelnut Allergens

    IKEA is recalling specific chocolate products due to undeclared milk, almond, and hazelnut allergens. Consumers with allergies should not consume these items.

    Product
    Choklad Not; Milk Chocolate with hazelnut Net Wt 3.5 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-1707-2017·2017-04-12

    Philips IntelliVue MX4O Monitor Recall for Alarm Failure

    Philips is recalling IntelliVue MX4O Patient Wearable Monitors that may fail to switch to Monitor Mode with audible alarms if the connection to the central system is lost.

    Product
    Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2017·2017-04-12

    Centurion Convenience Kits Recalled Due to Sterile Packaging Breach

    Centurion Medical Products is recalling 540 Convenience Kits containing eye pads due to a potential breach in sterile packaging.

    Product
    CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1741-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.

    Product
    Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1836-2017·2017-04-12

    Kwei Chow Mustard Bamboo Shoots Recalled for Undeclared Wheat

    Kwei Chow Sauce Industry Co., Ltd. is recalling specific jars of Mustard Bamboo Shoots with chili in oil because they contain undeclared wheat.

    Product
    Kwei Chow brand Mustard Bamboo Shoots with chili in oil, net weight 7.40 Oz, sauce in glass jars, shelf stable
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1862-2017·2017-04-12

    McShare's Nutritional Premix Recalled for Undeclared Soy Ingredient

    McShare's Inc is recalling iXL Advanced Performance Matrix Nutritional Premix because it contains low levels of undeclared soy.

    Product
    iXL Advanced Performance Matrix, Nutritional Premix, Net Wt. 50 lbs., Item No. 136375.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1731-2017·2017-04-12

    Centurion Ophthalmic Dressing Kits Recalled for Sterile Packaging Breach

    Centurion Medical Products is recalling 210 ophthalmic dressing kits due to a potential breach in the sterile packaging of the included eye pads.

    Product
    OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states