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.

23701–23725 of 50435

  • HighFDA (Devices)·Z-1311-2020·2020-02-26

    Nobel Biocare Dental Drills Recalled Due to Packaging Seal Defects

    Nobel Biocare is recalling 264 tapered dental drills because a packaging sealing defect may compromise sterility during shelf life.

    Product
    Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0725-2020·2020-02-26

    CSM Bakery Products Recalls Simplicious Cream Cheese Icing Due to Plastic Contamination

    CSM Bakery Products is recalling 18 lb. pails of Simplicious Cream Cheese Icing because pieces of plastic polymer were introduced into the sugar system.

    Product
    18 lb. pail SIMPLICIOUS CREAM CHEESE ICING 18#PL, MDM # 10202840, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·20V113000·2020-02-26

    Thomas Built Buses Saf-T-Liner C2 Recall for Exterior Light Failure

    Daimler Trucks North America is recalling 2017-2020 Thomas Built Buses Saf-T-Liner C2 school buses because the exterior warning lights and stop sign may fail, increasing injury risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2020·2020-02-26

    Hitachi Medical Systems Recalls 18 Ultrasound Probes Due to Mis-Wiring

    Hitachi Medical Systems America Inc is recalling 18 UST-2265-2 ultrasound probes due to potential mis-wiring that may cause decreased sensitivity and lower peak velocity readings.

    Product
    UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0729-2020·2020-02-26

    CSM Bakery Products Recalls Donut Icing Due to Plastic Polymer Contamination

    CSM Bakery Products is recalling 43 lb. pails of White 'n Glossy Icing donut icing because pieces of plastic polymer were introduced into the sugar system.

    Product
    43 lb. pail WHITE 'N GLOSSY ICING donut icing, MDM # 10203280, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2020·2020-02-26

    Siemens Dimension Vista Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine reagent because it may produce falsely depressed results for patients taking phenindione.

    Product
    Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 197 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.

    Product
    Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20079·2020-02-26

    Home Depot Recalls 4-Drawer Whitewash Chests Due to Tip-Over Hazards

    Home Depot is recalling approximately 200 4-Drawer Whitewash Chests because they are unstable if not anchored to the wall, posing tip-over and entrapment hazards.

    Product
    Home Decorators Collection Print Block 4-Drawer Whitewash Chest
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2020·2020-02-26

    Philips HeartStart FRx AED Recalled for Quality Standards Violation

    Philips is recalling 44 HeartStart FRx AED units because their Printed Circuit Assemblies were not manufactured or repaired according to quality standards.

    Product
    Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1274-2020·2020-02-26

    Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0709-2020·2020-02-26

    Taspen's Organics Respiratory Tea Recalled Due to Coltsfoot Ingredient

    Green Water, LLC is recalling Taspen's Organics Respiratory Tea because it contains Coltsfoot, an ingredient not intended for internal use.

    Product
    Taspen's Organics Respiratory Tea, sold in 2 oz packages
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1301-2020·2020-02-26

    Cardinal Health Recalls Presource Procedure Packs Due to Sterility Concerns

    Cardinal Health is recalling Presource Procedure Packs containing AAMI Level 3 surgical gowns because they may not be sterile. This could increase the risk of surgical site infections.

    Product
    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2020·2020-02-26

    Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture 13-0 due to potential packaging integrity issues that may impact sterility.

    Product
    Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2020·2020-02-26

    Siemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images

    Siemens is recalling 475 Luminos Agile Max devices due to a software bug that may assign one image to two patients, potentially affecting diagnosis.

    Product
    Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2020·2020-02-26

    Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns

    Nobel Biocare is recalling 8 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2020·2020-02-26

    Siemens Recalls ADVIA Chemistry CardioPhase hsCRP Calibrator Due to Accuracy Drift

    Siemens Healthcare Diagnostics is recalling 844 units of ADVIA Chemistry CardioPhase hsCRP Calibrator because accuracy has drifted from reference materials, causing high bias in quality control and patient sample recovery.

    Product
    ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2020·2020-02-26

    Siemens Dimension Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagent because it may produce falsely low results for patients taking phenindione.

    Product
    Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0730-2020·2020-02-26

    Safeway Cream Cheese Icing Recalled for Plastic Polymer Contamination

    CSM Bakery Products is recalling 32 lb. pails of Safeway Cream Cheese Icing because pieces of plastic polymer were introduced into the sugar system.

    Product
    32 lb. pail SAFEWAY CREAM CHEESE ICING, MDM # 10203458, Distributed by Safeway Inc. PO Box 99 Pleasanton, CA 94566-0009
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0720-2020·2020-02-26

    CSM Bakery Products Recalls Frozen Chocolate Chip Cookie Dough Due to Plastic

    CSM Bakery Products is recalling specific lots of frozen chocolate chip cookie dough because pieces of plastic polymer were introduced into the sugar system.

    Product
    30 lb. cases of 480 1.0 oz frozen chocolate chip cookie dough, MDM # 10194622, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2020·2020-02-26

    Philips CombiDiagnost GCF X-ray System Software Recall

    Philips is recalling 116 CombiDiagnost GCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.

    Product
    CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2020·2020-02-26

    Siemens Atellica CH Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagent due to potential falsely depressed results for patients on phenindione therapy.

    Product
    Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2020·2020-02-26

    Siemens Ysio Max Radiographic System Recalled for Software Bug

    Siemens Medical Solutions is recalling 507 Ysio Max radiographic systems because a software bug may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0713-2020·2020-02-26

    New Seasons Market Recalls Vegetarian Lasagna Due to Undeclared Soy

    New Seasons Market LLC is recalling 30 units of Vegetarian Lasagna With Gluten-Free Pasta because BBQ sauce containing soy was used instead of marinara, and the label does not declare soy.

    Product
    Vegetarian Lasagna With Gluten-Free Pasta, New Seasons Market brand. Product is packaged in a grab "n" go aluminum containter with a clear dome lid, and labeled with a scale PLU label. UPC 252390 706998. The CORRECT label reads in part: "*** VEGETARIAN LASAGNA WITH…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1275-2020·2020-02-26

    Polysorb Suture Recall Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact sterility.

    Product
    Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide