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.

29951–29975 of 50499

  • HighFDA (Devices)·Z-0493-2018·2018-02-07

    Horiba Medical Recalls ABX PENTRA Reagent Cups Due to Fit Issues

    Horiba Medical is recalling ABX PENTRA reagent cups that may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0413-2018·2018-02-07

    Ormco/Sybronendo Recalls Elements Obturation Units and Buchanan Heat Pluggers

    Ormco/Sybronendo is recalling 25,765 Elements Obturation Units and Buchanan Heat Pluggers because the pluggers may overheat during use.

    Product
    Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0465-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2018·2018-02-07

    Baxter Recalls 500mL IntraVia Containers Due to Potential Sterility Leak

    Baxter Healthcare is recalling 29,088 units of 500mL IntraVia containers in the US and Canada because a leak may allow microbial contamination of the sterile fluid path.

    Product
    Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0435-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the device from being properly assembled.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the set screw and sleeve assembly from staying in place.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2018·2018-02-07

    Beaver-Visitec Recalls Safety Knives Due to Retracted Protective Shield

    Beaver-Visitec International Inc. is recalling specific EdgeAhead Safety Knives because the protective shield retracted, exposing the blade.

    Product
    bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0695-2018·2018-02-07

    Hom'ade Foods Recalls Mary B's Biscuits Due to Listeria Risk

    Hom'ade Foods is recalling Mary B's Made with Whole Grain Bulk Biscuits because they may be contaminated with Listeria monocytogenes.

    Product
    Mary B's Made with Whole Grain, 220CT, Bulk Biscuits
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0494-2018·2018-02-07

    Horiba Medical Recalls ABX PENTRA Reagent Cups for Fit Issues

    Horiba Medical is recalling 15 mL reagent cups for ABX PENTRA analyzers because they may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2018·2018-02-07

    MicroAire Recalls Sterile Twist Drills Due to Incorrect Size Inclusion

    MicroAire Surgical Instruments is recalling 42 sterile twist drills because one lot contained an incorrect 2.0mm drill alongside the correct 1.6mm drill.

    Product
    SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0755-2018·2018-02-07

    Wegmans Shrimp Scampi Recalled for Undeclared Soy Lecithin

    Wegmans is recalling Ready To Cook Shrimp Scampi because it may contain undeclared soy lecithin, a potential allergen.

    Product
    Wegmans Ready To Cook Shrimp Scampi, 6 oz. UPC: 2-16151-00000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0753-2018·2018-02-07

    Wegmans Tom Tom Shrimp Recalled for Undeclared Wheat

    Wegmans is recalling Ready To Cook Tom Tom Shrimp with Sauce because the product may contain undeclared wheat.

    Product
    Wegmans Ready To Cook Tom Tom Shrimp with Sauce, 11 oz UPC: 2-06048-00000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0487-2018·2018-02-07

    GE Healthcare CARESCAPE Central Station software recall for communication issues

    GE Healthcare is recalling CARESCAPE Central Station software version 2.0.2 because units may experience unexpected network communication issues after boot-up or restart.

    Product
    GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0438-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0703-2018·2018-02-07

    Whole Food Market Recalls Cheesecake Bars for Undeclared Almond Flour

    Whole Food Market is recalling 20 cases of Cheesecake Bars sold in Connecticut, Massachusetts, and Rhode Island because the product may contain undeclared almond flour.

    Product
    Cheesecake Bars, PLU number 240801, 2 oz. UPC: 0240801001992
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0484-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a manufacturing rework error may have displaced internal components, preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
    Category
    Medical Device
    Distribution
    Distributed nationwide