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.

45376–45400 of 50512

  • HighNHTSA·12V338000·2012-07-19

    Honda Recalls 2012 CR-V and 2013 Acura ILX for Door Latch Defect

    Honda is recalling 2012 CR-V and 2013 Acura ILX vehicles because a door latch cable may loosen, preventing the door from latching properly and increasing injury risk.

    Product
    ACURA — ACURA, HONDA ILX, CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2012·2012-07-18

    superDimension Systems Software Recall Due to Locatable Guide Malfunction

    superDimension, Inc. is recalling Systems with Software Version 4.0-4.9 because they fail to recognize the Locatable Guide.

    Product
    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2012·2012-07-18

    GE Axcess Cranial Screw Recalled Due to Breakage During Insertion

    GE Healthcare is recalling 15 kits of Axcess Cranial Screws because they may break during insertion, posing a potential health hazard.

    Product
    The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1967-2012·2012-07-18

    Edwards Lifesciences Recalls Rigid Suction Wands Due to Tip Detachment Risk

    Edwards Lifesciences is recalling Rigid Suction Wands (models S033 and SPC2081) because the plastic tip may detach during use.

    Product
    Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2012·2012-07-18

    Drager PT 4000 Phototherapy System Recalled for Incorrect Fuse Rating

    Draeger Medical Systems is recalling 65 Drager PT 4000 Phototherapy Systems because they contain a 16 Amp fuse instead of the specified 1.6 Amp fuse, posing a risk of overheating.

    Product
    Drager PT 4000 Phototherapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2012·2012-07-18

    Civco VirtuTRAX Electromagnetic Sensor Recall Due to Calibration Error

    Civco Medical Instruments is recalling 24 VirtuTRAX Instrument Navigator kits because incorrect sensor calibration may cause variability in projected needle paths during ultrasound procedures.

    Product
    CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080. The firm name on…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1977-2012·2012-07-18

    Abbott i-Stat Analyzer Recall for Excessive Heat in Battery Area

    Abbott Point of Care is recalling i-Stat Analyzers because the battery area can become uncomfortably hot to touch. This is a recall extension.

    Product
    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1755-2012·2012-07-18

    Inventure Foods Recalls T.G.I. Friday's Mozzarella Sticks for Metal Particles

    Inventure Foods is recalling T.G.I. Friday's Mozzarella Sticks because tiny metal particles may be present in the seasoning.

    Product
    T.G.I. Friday's Mozzarella Sticks 2.25oz, 3.5oz, and 4.8 oz. Item#30187, 30588, 30588B, 30707, 30819, 30834.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1946-2012·2012-07-18

    Argon Safedraw Venous Close Loop System Recalled for Pouch Seal Defect

    Argon Medical Devices is recalling 10 Safedraw Venous Close Loop System blood sampling sets in Missouri due to a potential pouch seal defect that may compromise the sterile barrier.

    Product
    Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1954-2012·2012-07-18

    CIVCO General Purpose Sensor Recalled for Calibration Errors

    Civco Medical Instruments is recalling 100 CIVCO General Purpose Sensors because incorrect calibration may cause variability in the projected position of the needle path.

    Product
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part…
    Category
    Medical Device
    Distribution
    6 states
  • HighCPSC·12227·2012-07-18

    Samuel Lawrence Furniture Recalls Bordeaux Sleigh Beds Due to Fall Hazard

    Samuel Lawrence Furniture is expanding a recall of Bordeaux Collection sleigh beds because the headboard or footboard hardware can loosen or detach, posing a fall hazard.

    Product
    Full- and Twin-Size Bordeaux Collection Bed Frames
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1953-2012·2012-07-18

    Civco General Purpose Sensor Recalled for Calibration Errors

    Civco Medical Instruments is recalling 30 kits of General Purpose Sensors due to incorrect calibration that may cause variability in needle path projection.

    Product
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1948-2012·2012-07-18

    ArjoHuntleigh Recalls Chorus Mobile Patient Lifters Due to Injury Risk

    ArjoHuntleigh is recalling specific Chorus Mobile Patient Lifters because an exposed metal support bracket can cause injuries when the knee pad assembly is removed.

    Product
    Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1414-2012·2012-07-18

    Kleenex Luxury Foam Hand Sanitizer Recalled for Microbial Contamination

    Kimberly-Clark is recalling specific lots of Kleenex Luxury Foam Hand Sanitizer found to be contaminated with Burkholderia cepacia complex.

    Product
    Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1728-2012·2012-07-18

    Rhee Brothers Frozen Boiled Baby Clams Recalled for Norovirus Contamination

    Rhee Brothers Incorporated is recalling frozen boiled baby clams from South Korea due to potential Norovirus contamination. The product was distributed nationwide.

    Product
    Clams, Frozen Boiled Baby, in shell, 10 oz packages, 24 pkgs/carton, item #20699K. UPC 081652 206996.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1957-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Central Control Module Recall

    Terumo is recalling 992 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.

    Product
    Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2012·2012-07-18

    Philips Intellispace Portal software recalled for tumor measurement errors

    Philips Medical Systems is recalling Intellispace Portal software because tumor measurements are not recalculated when lesion contours are edited.

    Product
    Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Battery Depletion Issues

    Terumo is recalling approximately 993 Advanced Perfusion System 1 units because the battery may deplete faster than expected during shutdown, potentially causing unexpected system failure.

    Product
    System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Food)·F-1754-2012·2012-07-18

    Sienna Bakery Cookies Recalled for Undeclared Walnut Allergen

    Best Maid Cookie Company is recalling Sienna Bakery Oatmeal Walnut Raisin cookies because they may be packed in boxes labeled for a different product, resulting in an undeclared walnut allergen.

    Product
    Sienna Bakery¿ Oatmeal Walnut Raisin Gourmet Cookies, UPC 093901165992, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, RAISINS, BROWN SUGAR, OATS, WALNUTS, BUTTER, WHOLE EGGS, MARGARINE(PARTIALLY HYDROGENATED SOYBEAN AND…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1742-2012·2012-07-18

    Assi Brand Korean Oysters Recalled for Insanitary Conditions

    Korean Farm, Inc. is recalling Assi Brand oysters because they were prepared under insanitary conditions, posing a risk of contamination with filth.

    Product
    IQF Oysters 3lbs, Assi Brand, Item# 20083K,10x3 lb; Oyster Block, Assi Brand, item# 20085K, 30x1 lb; Oysters 8 oz - Tiny, Assi Brand, item# 20086, 40x8 oz; IQF Oysters 20 oz - Tiny, Assi Brand, item#20093, 20x20 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2012·2012-07-18

    Abbott i-Stat Analyzers Recalled Due to Excessive Heat in Battery Area

    Abbott Point of Care is recalling i-Stat Model 200 and 300 analyzers because they may become uncomfortably hot to touch near the battery.

    Product
    iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1952-2012·2012-07-18

    Civco VirtuTRAX Electromagnetic Sensor Recalled for Calibration Errors

    Civco Medical Instruments is recalling 221 VirtuTRAX kits because the electromagnetic sensors were incorrectly calibrated, which may cause variability in projected needle paths.

    Product
    CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1947-2012·2012-07-18

    Arjo Encore Mobile Patient Lifter Recalled for Exposed Metal Bracket Injury Risk

    ArjoHuntleigh is recalling specific Encore Mobile Patient Lifters because removing the knee pad assembly can expose a metal support bracket, posing an injury risk to patients.

    Product
    Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1747-2012·2012-07-18

    Giusto's Wheat Germ Recalled Due to Metal Fragment Contamination

    Giusto's Specialty Foods LLC is recalling 25 lb bags of raw wheat germ because the product is contaminated with metal fragments.

    Product
    Giusto's Wheat Germ, Raw, Net Wt. 25 lb, (11.34 Kg) paper bag; Item number: 154205 Giusto's 344 Littlefield Ave. South Francisco, CA 94080
    Category
    Food
    Distribution
    3 states