The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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25326–25350 of 26130

  • HighFDA (Devices)·Z-2035-2021·2021-07-14

    Cesarean Birth Drapes Recalled Due to Sticking Plastic Film

    Cardinal Health is recalling 1,638 units of Sterile Cesarean Birth Drapes due to defective plastic film that prevents proper unfolding and application during surgery.

    Product
    Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0768-2021·2021-07-14

    Jersey Cookie Monster Ice Cream recalled for undeclared soy

    Greenwood Ice Cream is recalling Jersey Cookie Monster Ice Cream because the ingredient statement does not include soy, posing a risk to consumers with soy allergies.

    Product
    JERSEY COOKIE MONSTER ICE CREAM 3 GALLONS (11.34 LITERS) MFG: GREENWOOD ICE CREAM CO LTD 4829 PEACHTREE ROAD, ATLANTA, GA 30341 UPC 0 12609 06378 0
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2003-2021·2021-07-14

    VISIONIST CRT-P Pacemaker Recalled Due to Battery Depletion Risk

    Boston Scientific has recalled 5,920 VISIONIST CRT-P pacemakers due to hydrogen gas buildup that can compromise a capacitor and cause accelerated battery depletion. Affected patients should contact their healthcare provider for device evaluation.

    Product
    VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2040-2021·2021-07-14

    FilmArray Pneumonia Diagnostic Kits Recalled for False Negative Results

    BioFire Diagnostics is recalling 3,559 FilmArray Pneumonia Panel plus test kits globally due to stability failures causing increased false negative results between 6 and 12 months after manufacturing, potentially missing pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-2008-2021·2021-07-14

    Verigene Gram Negative Blood Culture Test Recalled for Potential False-Negative Results

    Luminex Corporation is recalling 17,110 units of the Verigene Gram Negative Blood Culture test (Model 20-006-021) due to potential false-negative results that may fail to detect Gram-negative bacterial infections.

    Product
    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0767-2021·2021-07-14

    Firebird Artisan Mills Brown Rice Flour Recalled for Salmonella Risk

    Firebird Artisan Mills Gluten Free Organic Brown Rice Flour (50 lb bags, Lot #F21-00198) is recalled due to potential Salmonella contamination. The affected product was distributed to CA, IA, IL, and NY.

    Product
    Firebird Artisan Mills Gluten Free Organic Brown Rice Flour, Net Wt: 50 lb / 22.7 kg. 500 North St W., Harvey, ND 58341
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2042-2021·2021-07-14

    Medtronic CoreValve Evolut PRO Delivery Catheter Actuator Separation Recall

    Medtronic is recalling 67,339 CoreValve Evolut PRO Delivery Catheter Systems manufactured before July 11, 2020, due to reports of actuator separation that could affect device function.

    Product
    CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Food)·F-0769-2021·2021-07-14

    Milo's Sauce 5-Gallon Pails Recalled for Undeclared Fish Allergen

    Southern Classic Food Group LLC is recalling Milo's Sauce in 5-gallon pails due to undeclared fish allergen. Consumers with fish allergies should not consume the affected product.

    Product
    Milo's Sauce 5 gallon pails 24 pails per pallet
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2002-2021·2021-07-14

    VALITUDE CRT-P Pacemaker Recalled Due to Potential Accelerated Battery Depletion

    Boston Scientific VALITUDE CRT-P pacemakers (models U125 and U128) may experience hydrogen release that compromises the capacitor, causing accelerated battery depletion. Patients should consult their healthcare provider.

    Product
    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2001-2021·2021-07-14

    Altrua 2 Pacemakers at Risk from Hydrogen-Induced Battery Failure

    Boston Scientific is recalling 2,952 Altrua 2 pacemaker units (models S701, S702, S722) distributed worldwide due to hydrogen release that can damage the capacitor and accelerate battery depletion.

    Product
    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2032-2021·2021-07-14

    Nonsterile Femoral Angiography Drapes Recalled Due to Sticking Plastic Film Defect

    Cardinal Health is recalling 26,250 units of Nonsterile Femoral Angiography Drapes due to a manufacturing defect causing the drapes to stick and preventing proper application. This may compromise surgical site protection.

    Product
    Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2021·2021-07-14

    Cesarean Birth Drapes recalled due to defective plastic film causing sticking

    Cardinal Health is recalling Cesarean Birth Drapes due to a plastic film defect. The defect causes the drapes to stick, preventing proper unfolding and application during surgery.

    Product
    Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2021·2021-07-14

    Atellica analyzer valves recalled for manufacturing defect affecting diagnostic accuracy

    Siemens recalls Atellica analyzers (CH 930, IM 1300, IM 1600) due to valve manufacturing defects that may cause leaking and affect clinical test result accuracy.

    Product
    Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2021·2021-07-14

    Vivorte Bone Void Filler Recalled for Incorrect Expiration Date

    Vivorte, Inc. is recalling Trabexus EB bone filler due to an incorrect expiration date on product labels. The label shows expiration of 02-15-2019, but the actual expiration is 12-18-2018.

    Product
    Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2007-2021·2021-07-14

    Verigene Gram-Positive Blood Culture Test Recalled for Potential False-Negative Results

    Luminex Corporation is recalling the Verigene BC-GP blood culture test (Model 20-006-018) due to the potential for false-negative results. Approximately 36,416 units have been distributed worldwide.

    Product
    Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2021·2021-07-14

    Accolade Pacemakers Recalled for Hydrogen-Related Battery Depletion

    Boston Scientific is recalling Accolade pacemaker models L300, L301, L310, L311, L321, and L331 due to latent hydrogen release that compromises the capacitor and accelerates battery depletion.

    Product
    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2038-2021·2021-07-14

    Angiography and Cesarean Birth Drapes recalled due to sticking defect

    Cardinal Health is recalling Nonsterile Femoral Angiography and Cesarean Birth Drapes (15,360 units) because plastic film causes sticking that may prevent proper unfolding and application.

    Product
    Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2021·2021-07-14

    Siemens Atellica Analyzer Valves Recalled for Manufacturing Defect Risk

    Siemens Healthcare Diagnostics has recalled Atellica CH 930 Analyzer valves that may malfunction due to a manufacturing defect. The affected valves may wear and leak over time, potentially impacting diagnostic test accuracy.

    Product
    Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2041-2021·2021-07-14

    Medtronic CoreValve Evolut R Delivery Catheter System Recalled for Actuator Separation

    Medtronic is recalling CoreValve Evolut R Delivery Catheter Systems due to reports of actuator separation. The affected devices, manufactured before July 11, 2020, were distributed globally.

    Product
    CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-2014-2021·2021-07-14

    ADVIA Chemistry XPT System Software May Report Incorrect Patient Test Results

    Siemens Healthcare is recalling certain ADVIA Chemistry XPT systems with software version 1.4 or lower due to a default mixer failure detection setting that may allow incorrect patient lab results to be reported without alerting clinicians.

    Product
    The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2013-2021·2021-07-14

    Randox RX Imola Analyzer Software Freeze Recall - 50 Units Affected

    Randox recalls 50 RX Imola Analyser units nationwide and in Puerto Rico due to software freezing that prevents test results from displaying.

    Product
    Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2021·2021-07-14

    FREELITE Kappa Free Kit quality control bias recall

    The Binding Site Group is recalling the FREELITE Human Kappa Free Kit due to quality control bias of approximately 10% compared to assigned values. Specific lot numbers distributed worldwide are affected.

    Product
    FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1999-2021·2021-07-14

    Proponent pacemakers recalled for accelerated battery depletion risk

    Boston Scientific has recalled certain Proponent pacemaker models worldwide. Hydrogen gas may accumulate inside the device, compromising the capacitor and causing accelerated battery depletion.

    Product
    Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2033-2021·2021-07-14

    Sterile Angiography Drapes Recalled Due to Sticking Plastic Film Defect

    Cardinal Health is recalling 3,192 units of Sterile Radial/Femoral Angiography Drapes due to sticking plastic film that may prevent proper unfolding and application during surgical procedures.

    Product
    Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide