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 the agency’s own highest classification or reported deaths or serious injuries, 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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

14676–14700 of 40151

  • ModerateFDA (Devices)·Z-1578-2021·2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect

    ICU Medical is recalling specific lots of REF CL3538 Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1565-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect and Leakage

    ICU Medical is recalling specific lots of Oncology Kits due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1586-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect

    ICU Medical is recalling specific lots of Spinning Spiros male luers because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1590-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Leakage Defect

    ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.

    Product
    REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2021·2021-05-19

    Fresenius AquaBplus Water Purification System Recalled for Installation Error

    Fresenius Medical Care is recalling 27 AquaBplus water purification systems because an installation guideline error may reduce the effectiveness of heat disinfection.

    Product
    AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1560-2021·2021-05-19

    Haag-Streit LENSTAR LS900 Software Recall for Data Mixing Errors

    Haag-Streit USA Inc is recalling Eyesuite 9.3.1 software for LENSTAR LS900 devices due to potential mixing of patient names and examination data.

    Product
    Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1587-2021·2021-05-19

    ICU Medical Recalls Bag Spike Adapters Due to Molding Defect

    ICU Medical is recalling specific lots of Bag Spike Adapters due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1575-2021·2021-05-19

    ICU Medical Recalls Smallbore Extension Sets Due to Molding Defect

    ICU Medical is recalling specific lots of smallbore extension sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1561-2021·2021-05-19

    Remel Bile Esculin Azide Agar Recalled for Growth of E. faecalis

    Remel Inc is recalling Bile Esculin Azide Agar with Vancomycin because the media allows growth of E. faecalis ATCC 29212.

    Product
    Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1589-2021·2021-05-19

    ICU Medical Recalls IV Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of IV administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1562-2021·2021-05-19

    Musculoskeletal Transplant Foundation Recalls AFT Straight Tubes Due to Filling Error

    Musculoskeletal Transplant Foundation is recalling AFT Straight Tubes that were filled only halfway instead of three-quarters, which may cause surgery delays.

    Product
    AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1563-2021·2021-05-19

    Randox Calibration Serum Level 3 Recalled for Bilirubin Bias

    Randox Laboratories is recalling 98 kits of Calibration Serum Level 3 (CAL 3) due to a positive bias in bilirubin measurements.

    Product
    Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1574-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1554-2021·2021-05-19

    Medical Action Industries Recalls Central Line Dressing Change Kits

    Medical Action Industries is recalling Central Line Dressing Change Kits due to a potential breach in the package integrity of a component.

    Product
    Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2021·2021-05-12

    Greiner Bio-One Recalls VACUETTE Blood Collection Tubes for Insufficient Draw Volume

    Greiner Bio-One is recalling VACUETTE blood collection tubes because insufficient draw volume may cause erroneous coagulation test results.

    Product
    VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2021·2021-05-12

    Medtronic Recalls CareLink SmartSync Device Manager Due to Software Error

    Medtronic is recalling 16,311 CareLink SmartSync Device Managers because a software issue may overestimate the remaining battery life of implanted cardiac devices.

    Product
    CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1533-2021·2021-05-12

    GE Healthcare Recalls Centricity Universal Viewer for Patient Data Mismatch Risk

    GE Healthcare is recalling 112 units of Centricity Universal Viewer software because a specific configuration may display comparison exams from the wrong patient.

    Product
    Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2021·2021-05-12

    Medtronic Recalls CRT-P Quad Models Due to Software Longevity Error

    Medtronic is recalling 45,411 CRT-P Quad implantable devices worldwide because a software issue overestimates battery longevity for six months before replacement is due.

    Product
    CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1535-2021·2021-05-12

    Medtronic Intellis Recharger Recalled for Potential Unintended Heating

    Medtronic is recalling 79,616 Intellis Model 97755 Rechargers worldwide due to a potential for unintended heating.

    Product
    Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator  Intellis Model 97716 Implanted Neurostimulator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1526-2021·2021-05-12

    Medtronic Recalls CRT-P Pacemakers Due to Longevity Estimation Error

    Medtronic is recalling specific implantable cardiac resynchronization therapy pacemakers because a longevity estimation error may occur in the early years of device life.

    Product
    Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1532-2021·2021-05-12

    Medtronic Abre Venous Self-expanding Sent System Recall for Incorrect Size Labeling

    Medtronic is recalling 23 Abre Venous Self-expanding Sent Systems because the device size is incorrectly printed on the device itself, though the packaging is labeled correctly.

    Product
    Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide