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.

40776–40800 of 50511

  • HighFDA (Devices)·Z-2098-2014·2014-07-30

    Terumo Recalls Sarns Soft-arc Aortic Cannula Due to Loose Fiber Particulate

    Terumo CVS is recalling 20 units of Sarns Soft-arc Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2014·2014-07-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Electrolyte Error Codes

    Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 Lactate Cartridges because they may display error codes for electrolyte parameters.

    Product
    RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2014·2014-07-30

    Terumo Recalls Sarns D4 Aortic Arch Cannulae Due to Particulate

    Terumo CVS is recalling Sarns D4 Aortic Arch Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14242·2014-07-29

    Philips Recalls Lightolier Glass Lenses Due to Laceration Hazard

    Philips Lighting is recalling Lightolier AF4SY decorative glass lenses because they can shatter and cause cuts. Consumers should remove the lenses and contact Philips for a free replacement.

    Product
    Philips "Lightolier" brand AF4SY Decorative Glass Lens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14E049000·2014-07-28

    Delphi Recalls Fuel Pump Modules for 2005-2010 Honda Odyssey Vehicles

    Delphi is recalling replacement fuel pump modules for 2005-2010 Honda Odysseys that may display incorrect fuel levels, increasing the risk of stalling and crashes.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V455000·2014-07-25

    KME Fire Fighting Vehicles Recalled for Seat Belt Latch Defect

    Kovatch is recalling 2013-2014 KME Panther and Predator fire fighting vehicles because seat belt buckles may fail to release, hindering emergency egress.

    Product
    KME — KME PANTHER, PREDATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-072514·2014-07-25

    Processed Breaded Chicken Products Produced Without Inspection

    USDA FSIS issued a public health alert for breaded chicken products from VU Foods, LLC, produced without inspection and deemed unfit for human consumption.

    Product
    FSIS Issues Public Health Alert for Processed Breaded Chicken Products Produced Without the Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·14E048000·2014-07-25

    Triangle Warning Signs Recalled for Inadequate Light Reflection

    W.W. Grainger is recalling triangle warning signs that may not reflect enough light, potentially failing to warn other drivers of parked vehicles.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V453000·2014-07-24

    Godwin Recalls Modified Ford Super Duty Trucks Due to Fire Risk

    Godwin is recalling certain modified Ford Super Duty trucks because oil from a PTO pressure switch may leak onto the exhaust, increasing fire risk.

    Product
    FORD — FORD F-550 SD, F-450 SD, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14241·2014-07-24

    Metabo Recalls Electric Angle Grinders Due to Laceration Hazard

    Metabo is recalling about 4,300 Ergo series 6-inch angle grinders because the on/off switch can stick in the "On" position, posing a laceration hazard.

    Product
    Metabo Ergo series 6-inch angle grinders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2014·2014-07-23

    Terumo Cardiovascular Procedure Kit Recall for Pumphead Leaks

    Terumo is recalling 256 Cardiovascular Procedure Kits because leaks were detected on the centrifugal pumphead during set-up and priming of the bypass circuit.

    Product
    Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V451000·2014-07-23

    GM Recalls 2015 SUVs for Unreinforced Roof Rail Air Bags

    General Motors is recalling 2015 Chevrolet and GMC SUVs because roof rail air bags may be punctured by roof carrier hardware, increasing injury risk.

    Product
    CHEVROLET — CHEVROLET, GMC TAHOE, YUKON, SUBURBAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2060-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP Coagulation Instruments

    Instrumentation Laboratory Co. is recalling 1,074 ACL TOP (Base) automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP (Base), automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2014·2014-07-23

    Stryker Communications Recalls SHAPE Arm Monitor Mounts

    Stryker Communications is recalling SHAPE Arm monitor mounts because the mount may detach if a lock washer and screw are missing.

    Product
    SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682400256…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2052-2014·2014-07-23

    Stryker SHAPE Arm Recall for Potential Monitor Mount Detachment

    Stryker Communications is recalling 953 SHAPE Arm components because the monitor mount may detach if a lock washer and screw are missing.

    Product
    SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2014·2014-07-23

    Baxter MiniCap with Povidone-Iodine Solution Recalled for Packaging Defects

    Baxter Healthcare is recalling 585,360 units of MiniCap with Povidone-Iodine Solution due to inadequate iodine and packaging defects.

    Product
    Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 300 CTS Coagulation Instruments

    Instrumentation Laboratory Co. is recalling ACL TOP 300 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 300 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2187-2014·2014-07-23

    Zing Nutrition Bars Recalled for Undeclared Milk in Vegan Products

    NW Nutritional Foods LLC is recalling Zing Nutrition Bars labeled as vegan or dairy-free because they contain undeclared milk.

    Product
    There are three different labels for this product. Label #1 individual bar 100% Natural Zing Nutrition Bar, DARK CHOCOLATE SUNFLOWER MINT, Gluten Free & Vegan, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #1 display Carton 100% Natural…
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2076-2014·2014-07-23

    Pioneer Surgical Technology Recalls Tritium Sternal Plate System Due to Sterility Concerns

    Pioneer Surgical Technology is recalling 5 units of the Tritium Sternal Plate System in Texas and Florida due to a lack of sterility assurance.

    Product
    Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2014·2014-07-23

    Shape HF Cardiopulmonary System Recalled for Software Upgrade Requirement

    Shape Medical Systems is recalling 800 Shape HF Cardiopulmonary Systems because a mandatory software upgrade is required before using specific Disposable Patient Interface lots to prevent erroneous testing results.

    Product
    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach

    Smith & Nephew is recalling 907 units of SUTUREFIX Ultra S devices because a breach in the sterile barrier compromises the device's sterility.

    Product
    SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide