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.

13601–13625 of 53086

  • HighNHTSA·23V279000·2023-04-19

    Triple E RV Recalls 2020-2023 Wonder Motorhomes for Bed Bracket Defect

    Triple E RV is recalling 2020-2023 Wonder W24RTB motorhomes because an incorrectly installed bed stay bracket may fail, causing the bed lid to fall and increasing injury risk.

    Product
    TRIPLE E RV — TRIPLE E RV WONDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1384-2023·2023-04-19

    Knee Patella Drills Recalled for Incorrect Diameter Markings

    Encore Medical is recalling EMPOWR Knee Patella drills due to reversed diameter markings that could cause incorrect drill selection during surgery, leading to implant loosening or bone fracture.

    Product
    EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1371-2023·2023-04-19

    Inflatable Penile Prosthesis Recall Due to Potential Pump Failure Risk

    Coloplast is recalling certain inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure. No injuries have been reported.

    Product
    Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0719-2023·2023-04-19

    Animal Crackers in Meal Kits May Contain Metal Shavings

    E S Foods is recalling 1,044,918 meal kits nationwide due to potential bronze metal shavings in the animal crackers component. Consumers should not consume affected product.

    Product
    61498 Cheese Stick with Marinara Sauce with 2 Grains MB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0698-2023·2023-04-19

    Zone Perfect Fudge Graham bars recalled for hard plastic fragments

    Abbott Laboratories is recalling Zone Perfect Fudge Graham bars due to potential hard plastic fragments in the product. Affected bars were distributed to 36 U.S. states.

    Product
    Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-1382-2023·2023-04-19

    Philips DigitalDiagnost C50 Radiographic System Ceiling Suspension Malfunction Risk

    The Philips DigitalDiagnost C50 radiographic system's ceiling suspension may descend unintentionally if annual maintenance is skipped and power is interrupted, potentially injuring patients and operators.

    Product
    Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1390-2023·2023-04-19

    Unsterile Plain Gut Absorbable Sutures Recalled Due to Sterilization Defect

    Covidien recalled 3,228 units of Plain Gut Absorbable Sutures due to a sterilization defect. Unsterile sutures may cause infection or vision loss in eye surgery.

    Product
    Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2023·2023-04-19

    Swan-Ganz Thermodilution Catheter May Bend and Cause Monitor Error

    Edwards Lifesciences is recalling Swan-Ganz CCOmbo V thermodilution catheters because the distal end may bend beyond its intended curvature, potentially causing the patient monitoring device to display an error message.

    Product
    Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1375-2023·2023-04-19

    Titan inflatable penile prosthesis recalled due to premature pump failure risk

    Coloplast is recalling the Titan 0-Deg inflatable penile prosthesis due to decreased pump wall thickness that may cause premature device failure. The recall affects 23 units distributed worldwide.

    Product
    Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0723-2023·2023-04-19

    Animal Crackers in Meal Kits Recalled Due to Possible Metal Shavings

    E S Foods is recalling animal crackers in meal kits distributed nationwide because they may contain bronze metal shavings that could cause choking or internal injury if ingested.

    Product
    61151 Apple Muffin Top TSMB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2023·2023-04-19

    Inflatable penile prosthesis recalled due to pump wall thickness manufacturing defect

    Coloplast is recalling Titan NB inflatable penile prostheses with reduced pump wall thickness that may cause premature pump failure during normal use.

    Product
    Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Kit recalled due to reduced test specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP reagent kits due to reduced specificity that may cause false positive results. Four customer complaints documented discrepant results during validation testing.

    Product
    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0717-2023·2023-04-19

    Butterball Turkey Stick Meal Kits Recalled for Possible Metal Shavings

    E S Foods is recalling Butterball Turkey Stick meal kits nationwide due to possible bronze metal shavings in the animal crackers. Consumers should not consume these products.

    Product
    61404 Butterball Turkey Stick MB (meal box)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0803-2023·2023-04-19

    Protein bars recalled nationwide for undeclared cashew allergen

    Wellness Natural USA Inc. is recalling SimplyProtein peanut butter chocolate crispy bars sold at Costco due to undeclared cashew allergen. 2.46 million boxes are affected.

    Product
    SimplyProtein¿ Peanut Butter Chocolate Crispy 15-1.41 OZ (40 g) bar. (UPC 6 86207 00914 7) Sold in 15-count variety pack with two other flavors (Lemon Coconut and Chocolate Sea Salt) NET WT 21/16 OZ (600 g). Outside carton UPC 6 86207 80906 8. Packaged in a carboard box.…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2023·2023-04-19

    Chromic Gut Absorbable Sutures recalled due to sterilization failure

    Covidien is recalling Chromic Gut Absorbable Sutures due to a sterilization process failure that may result in unsterile product. Use of affected sutures may cause infection or, in eye surgery, vision loss.

    Product
    Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0726-2023·2023-04-19

    Animal Crackers in Meal Kits Recalled for Metal Shaving Contamination

    E S Foods is recalling animal crackers in meal kits nationwide due to potential bronze metal shavings. Consumers should not consume affected products and should return them to retailers.

    Product
    61246 Cheerios Cereal Bar BB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0722-2023·2023-04-19

    Meal Kits With Animal Crackers Recalled for Metal Shavings

    E S Foods is recalling meal kits nationwide due to potential bronze metal shavings in the animal crackers component. No illnesses have been reported.

    Product
    61119 RS Cinnamon Toast Crunch BB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2023·2023-04-19

    Thermodilution Catheter May Bend During Use, Causing Monitor Errors

    Edward Lifesciences Swan-Ganz thermodilution catheters may bend during use, potentially causing patient monitoring devices to display error messages. The FDA has recalled 326 affected units distributed nationwide.

    Product
    Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1351-2023·2023-04-19

    Outset Tablo Hemodialysis System Recall Due to Software Manufacturing Defect

    Outset Medical is recalling 374 Tablo hemodialysis systems due to a software malfunction introduced during manufacturing. The defect causes frequent high conductivity dialysate alarms in devices distributed nationwide.

    Product
    Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1364-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Premature Pump Failure Risk

    Coloplast is recalling 13 units of the Titan Touch NB Scrot Zero 18cm inflatable penile prosthesis due to decreased wall thickness that could cause premature pump failure.

    Product
    Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0720-2023·2023-04-19

    Meal Kits Recalled Due to Potential Metal Shavings in Animal Crackers

    E S Foods is recalling meal kits nationwide due to potential bronze metal shavings in animal crackers. The recall affects approximately 1,044,918 units.

    Product
    61520 Cheese Stick with 2 Grains and 1 Cup Fruit MB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled Due to Pump Failure Risk

    Coloplast is recalling the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis due to decreased wall thickness in the pump, which may cause premature failure with repeated use.

    Product
    Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2023·2023-04-19

    Inflatable Prosthesis Pump Assembly Recalled for Premature Failure Risk

    Coloplast is recalling 9 Titan Pump Assemblies for inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure during normal use.

    Product
    Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide