The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

6001–6025 of 21595

  • ModerateUSDA FSIS·pha-04022021-01·2021-04-02

    USDA Issues Public Health Alert for Raw Ground Chorizo Sausage

    USDA FSIS issued a public health alert for raw ground chorizo sausage due to possible contamination with hard crystalline material. No illnesses have been reported.

    Product
    FSIS Issues Public Health Alert for Raw Ground Chorizo Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1300-2021·2021-03-31

    Cardinal Health Recalls In-View Clear Leggings Due to Manufacturing Variance

    Cardinal Health is recalling In-View Clear Leggings Sterile because a manufacturing variance causes the plastic film to stick, potentially preventing proper application.

    Product
    In-View Clear Leggings Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1291-2021·2021-03-31

    Corin Trinity Acetabular System Recalled for Incorrect Size Labeling

    Corin Ltd is recalling 23 units of the Trinity Acetabular System because the size indicated on the packaging and patient stickers is incorrect.

    Product
    Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1288-2021·2021-03-31

    Siemens Recalls 29 Interventional Fluoroscopic X-Ray Systems for Shutdowns

    Siemens is recalling 29 interventional fluoroscopic X-ray systems because the power supply may cause the computer to shut down unexpectedly.

    Product
    Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1295-2021·2021-03-31

    Ortho-Clinical Diagnostics Recalls VITROS TIBC Calibrator Kits Due to Performance Shift

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 4 and Fe Slides because TIBC results may be approximately 80 ug/dL lower than expected.

    Product
    VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1290-2021·2021-03-31

    Corin Trinity Hip Prosthesis Heads Recalled for Incorrect Size Labeling

    Corin Ltd is recalling 23 units of Trinity Biolox Delta Ceramic Heads due to incorrect size labeling on packaging and patient stickers.

    Product
    Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titani
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2021·2021-03-31

    Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

    Baxter Healthcare is recalling 1,650 Prismaflex Control Units used for renal replacement therapy because tubing performance variability may cause alarms during or after system self-tests.

    Product
    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1304-2021·2021-03-31

    Cardinal Health Recalls Femoral Angiography Drapes Due to Sticking Defect

    Cardinal Health is recalling non-sterile femoral angiography drapes because a manufacturing defect causes them to stick, preventing proper application.

    Product
    Femoral Angiography Drape Bulk Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1277-2021·2021-03-31

    Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

    Baxter Healthcare is recalling Prismaflex Control Units because tubing variability may cause alarms during self-tests. The units are used for Continuous Renal Replacement Therapy.

    Product
    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1302-2021·2021-03-31

    Cardinal Health Recalls In-View Clear Leggings Due to Sticking Defect

    Cardinal Health is recalling In-View Clear Leggings because a manufacturing variance causes the plastic film to stick, preventing proper application.

    Product
    In-View Clear Leggings Bulk Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0304-2021·2021-03-24

    Spironolactone Tablets Recalled Due to Potential Labeling Mix-Up

    Bryant Ranch Prepack is recalling 12 bottles of Spironolactone 50 mg tablets because they may contain 25 mg tablets due to a labeling error.

    Product
    Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1249-2021·2021-03-24

    Medline Recalls RNA Medical Hemoglobin Control Product Due to Shipment Compromise

    Medline Industries is recalling 4 units of RNA Medical Hemoglobin Control product because the product was compromised during shipment. The recall affects distribution in Kentucky, Pennsylvania, and Ohio.

    Product
    RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1255-2021·2021-03-24

    R&D Systems Recalls Quantikine IVD Human sTfR Immunoassay Kits

    R&D Systems is recalling 156 Quantikine IVD Human sTfR Immunoassay kits due to low standard signals and out-of-specification controls.

    Product
    Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0308-2021·2021-03-24

    Breckenridge Recalls Omeprazole Capsules Due to Unknown Impurities

    Breckenridge Pharmaceutical is recalling 3,146 bottles of Omeprazole Delayed-Release Capsules, 20 mg, due to out-of-specification results for unknown impurities.

    Product
    Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0301-2021·2021-03-24

    Akorn Recalls Gabapentin Oral Solution Due to Impurity Specifications

    Akorn, Inc. is recalling Gabapentin Oral Solution because it failed impurity specifications during stability testing. The product was distributed nationwide.

    Product
    Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0344-2021·2021-03-24

    Minnesota Milk Bank Recalls Pasteurized Donor Human Milk

    Minnesota Milk Bank for Babies is recalling specific batches of pasteurized donor human milk due to potential trace amounts of dextromethorphan.

    Product
    MN Milk Bank for Babies Pasteurized Donor Human Milk. Volumne 4.0 fl oz., 120 mL
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0363-2021·2021-03-24

    Electrolit Fruit Punch Recalled for Undeclared Red Dye

    Laboratorios Pisa is recalling Electrolit Fruit Punch bottles and 6-packs because they contain undeclared FD&C Red No. 40.

    Product
    Electrolit Ponche/Fruit Punch; in 625 mL/21 oz and 300ML/10oz bottles; and Electrolit Fruit Punch 6 Pack, 625mL/21 oz; Packaged in a polypropylene bottle with volume capacity 625 mL and a polypropylene lid and liner with a high-density polyethylene safety ring.
    Category
    Food
    Distribution
    22 states
  • ModerateFDA (Drugs)·D-0300-2021·2021-03-24

    Direct Rx Recalls Nortriptyline HCL Capsules Due to cGMP Deviation

    Direct Rx is recalling 17 bottles of Nortriptyline HCL 10 mg capsules because the active ingredient was taken from an unqualified supplier lot.

    Product
    Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0333-2021·2021-03-17

    Sapphire Exchange Recalls Yum Crumbs for Undeclared Red #40

    The Sapphire Exchange is recalling Yum Crumbs, Strawberry Shortcake, due to undeclared Red #40. The voluntary recall covers 3,421 bottles distributed domestically.

    Product
    YUM CRUMBS, STRAWBERRY SHORTCAKE, 12 oz and 32 oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1188-2021·2021-03-17

    Siemens Dimension Vista HDLC Reagent Cartridges Recalled for Erroneous Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista HDLC reagent cartridges due to discolored reagents that may cause erroneous test results.

    Product
    Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1189-2021·2021-03-17

    Physio-Control Recalls LIFEPAK CR2 Defibrillators Due to Missing Lid Magnets

    Physio-Control is recalling 89,763 LIFEPAK CR2 defibrillators because missing lid magnets may cause premature battery depletion.

    Product
    PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is det
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1187-2021·2021-03-17

    Tosoh Thyroglobulin Antibody Calibrator Recalled for Calibration Failures

    Tosoh Bioscience Inc is recalling specific lots of Thyroglobulin Antibody Calibrators because some combinations with AIA PACKS resulted in unacceptable calibration values.

    Product
    Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the dia
    Category
    Medical Device
    Distribution
    Distributed nationwide