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.

19876–19900 of 50413

  • HighFDA (Devices)·Z-2039-2021·2021-07-14

    FilmArray Pneumonia Panel Kits Recalled Due to Shelf-Life False Negatives

    BioFire Diagnostics is recalling FilmArray Pneumonia Panel test kits globally due to stability failures that increase false negative results between 6 and 12 months of shelf life.

    Product
    FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
    Category
    Medical Device
    Distribution
    49 states
  • 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-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 (Devices)·Z-2037-2021·2021-07-14

    Sterile Femoral Angiography Drape Recall Due to Sticking Plastic Film

    Cardinal Health is recalling sterile femoral angiography drapes because the plastic film causes drapes to stick, which may prevent proper unfolding and application during procedures.

    Product
    Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - 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-2010-2021·2021-07-14

    Luminex Verigene C. difficile Test Kit Recalled for False-Negative Results

    Luminex Corporation is recalling 1,261 Verigene Clostridium difficile test kits due to potential for false-negative results. The kits may fail to detect C. difficile infections, potentially delaying diagnosis.

    Product
    Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2009-2021·2021-07-14

    Verigene Enteric Pathogens Test May Return False-Negative Results

    Luminex Corporation is recalling Verigene Enteric Pathogens diagnostic tests due to potential for false-negative results, which could miss serious bacterial infections.

    Product
    Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2021·2021-07-14

    Atellica IM 1300 Analyzer Valves Recalled Due to Manufacturing Defect

    Siemens is recalling Atellica IM 1300 diagnostic analyzer valves due to a manufacturing defect that may cause leaking and affect test result accuracy.

    Product
    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2021·2021-07-14

    Verigene Gram Negative Blood Culture Test Recalled for Risk of False-Negative Results

    Luminex Corporation is recalling 165 units of the Verigene BC-GNv2 diagnostic test worldwide due to the potential for false-negative results in blood culture testing.

    Product
    Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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-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
    48 states
  • 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-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-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-2006-2021·2021-07-14

    Luminex Verigene Respiratory Pathogens Test Recalled for False-Negative Risk

    Luminex Corporation is recalling 38,990 Verigene Respiratory Pathogens Flex nucleic acid tests due to potential false-negative results. The tests were distributed worldwide, including throughout the United States.

    Product
    Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
    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-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
  • 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-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-2043-2021·2021-07-14

    CoreValve Evolut PRO PLUS Delivery Catheter Systems recalled for actuator separation

    Medtronic is recalling CoreValve Evolut PRO PLUS Delivery Catheter Systems due to reports of actuator separation that could affect proper deployment of these cardiac devices.

    Product
    CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
    Category
    Medical Device
    Distribution
    48 states
  • 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-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