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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11601–11625 of 39932

  • HighFDA (Devices)·Z-0089-2023·2022-10-26

    Dimension Vista HDLC Reagent Cartridge Recalled for Inaccurate Lab Results

    Siemens is recalling 1,592 units of Dimension Vista HDLC reagent cartridges due to potential for erroneous test results. Affected cartridges may produce falsely high or low HDL cholesterol measurements.

    Product
    Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2023·2022-10-26

    Medicina ENFit enteral syringe recall due to material specification defect

    Medicina is recalling ENFit 1ml enteral syringes because the plunger was manufactured with polyethylene instead of approved polypropylene. This material defect could affect plunger function and device safety.

    Product
    Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2023·2022-10-26

    Medicina Reusable Oral Syringe recalled for incorrect plunger material

    Medicina Uk Ltd is recalling Medicina Reusable Oral Syringe 2.5ml units because plunger components were manufactured with polyethylene instead of the specified polypropylene material.

    Product
    Medicina Reusable Oral syringe 2.5ml Code: OTH25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0111-2023·2022-10-26

    Medicina Oral Tip Syringe recalled for unapproved plunger material

    Medicina Uk Ltd is recalling Medicina Oral Tip Syringe 2.5ml nationwide because the plunger component was manufactured with polyethylene instead of the approved polypropylene material.

    Product
    Medicina Oral Tip Syringe 2.5ml Code: OT25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0117-2023·2022-10-26

    MitraClip G4 and TriClip G4 Cardiac Devices Recalled for Clip Locking Malfunction

    Abbott has recalled MitraClip G4 and TriClip G4 cardiac repair devices due to clip locking malfunctions that may prevent proper device deployment. These malfunctions could lead to failed procedures and serious complications including device embolization.

    Product
    Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0103-2023·2022-10-26

    Optima Coil System Pouch Labels Do Not Match Carton Labels

    BALT USA is recalling Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10 due to a labeling discrepancy where pouch labels do not match carton labels. These endovascular devices require verification before use.

    Product
    Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0108-2023·2022-10-26

    Medicina ENFit Enteral Syringes Recalled for Incorrect Plunger Material

    Medicina Uk Ltd is recalling Medicina ENFit 5ml Reusable Enteral Syringes because the plunger component was manufactured with polyethylene instead of the specified polypropylene material.

    Product
    Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0001-2023·2022-10-19

    Jiangsu Well Biotech COVID-19 test kits distributed without FDA authorization

    Approximately 620,000 COVID-19 rapid test devices were distributed in the U.S. without FDA Emergency Use Authorization or approval. Consumers should not use these unauthorized test kits.

    Product
    Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0052-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Kit Recalled for Mislabeled Expiration Dates

    Hobbs Medical recalls Freeman Pancreatic Flexi-Stent kits with incorrect expiration dates on the label, which extends the stated shelf life and could allow use of expired devices.

    Product
    Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent label displays incorrect expiration date

    Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on their labels. The labeling error extends the shelf life beyond the intended timeframe.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6584
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0030-2023·2022-10-19

    Hobbs Helical Retrieval Basket Recall Due to Incorrect Expiration Date

    Hobbs Medical is recalling Helical Retrieval Baskets (Catalog 4822) with incorrect expiration dates on device labels. The mislabeled dates extend the shelf life, risking use of expired devices that may not perform as intended.

    Product
    Hobbs Helical Retrieval Basket Catalog Number: 4822
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0044-2023·2022-10-19

    Biliary Pigtail Stent Kits Recalled Due to Incorrect Expiration Date Labels

    Hobbs Medical recalls Biliary Pigtail Stent Kits with labeling showing incorrect expiration dates that extend the shelf life. Affected kits were distributed to US and international customers from March 2018 to September 2020.

    Product
    Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent recalled for incorrect expiration date labeling

    Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on product labels. The labeling error extends the stated shelf life, potentially allowing use of degraded devices.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6567
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0084-2023·2022-10-19

    Prismaflex ST Renal Therapy Sets Recalled for Mistranslated Safety Instructions

    Baxter Healthcare is recalling 1,068,560 Prismaflex ST renal replacement therapy sets nationwide. The recall is due to a mistranslation in the Estonian instructions that contains contradictory information about patient weight restrictions.

    Product
    Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0041-2023·2022-10-19

    Hobbs Medical Recalls Biliary Stent Kits Due to Mislabeled Expiration Dates

    Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits with incorrect expiration dates displayed on device labels. Affected devices distributed from March 2018 through September 2020 may be used beyond their validated shelf life.

    Product
    Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0031-2023·2022-10-19

    Hobbs Helical Retrieval Basket recalled for incorrect expiration date

    Hobbs Medical recalled 10 units of its Helical Retrieval Basket due to mislabeled expiration dates that extend the product's shelf life, affecting devices distributed in the US and select countries between 2018 and 2020.

    Product
    Hobbs Helical Retrieval Basket Catalog Number: 4824
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2023·2022-10-19

    Hobbs Posi-Stop Injection Needle recalled for incorrect expiration date labeling

    Hobbs Medical recalled Posi-Stop Injection Needles with incorrect expiration dates on labels, potentially allowing use of units past actual expiration. The recall affects 17 units distributed in the US and several countries.

    Product
    Hobbs Posi-Stop Injection Needle Catalog Number: 4722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2023·2022-10-19

    Hobbs Biliary Pigtail Stent Kits recalled for incorrect expiration date

    Hobbs Medical recalls biliary stent kits with incorrect expiration dates that extend shelf life. The kits were distributed from 2018 to 2020 in the US and select countries.

    Product
    Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2023·2022-10-19

    Hobbs Medical Polypectomy Snare recalled for incorrect expiration date on label

    Hobbs Medical is recalling its Polypectomy Snare for an incorrect expiration date on the label that extends shelf life. Affected devices were distributed in the US and other countries from March 2018 to September 2020.

    Product
    Hobbs Medical Polypectomy Snare Catalog Number: 4563
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2023·2022-10-19

    Hobbs Biliary Pigtail Stent Kits Recalled Due to Incorrect Expiration Date Label

    Hobbs Medical is recalling Biliary Pigtail Stent Kits distributed from March 2018 to September 2020 due to incorrect expiration date labels that extend the shelf life beyond the actual safe period.

    Product
    Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0035-2023·2022-10-19

    Hobbs Medical Grasping Forceps Recalled for Incorrect Expiration Dates

    Hobbs Medical Grasping Forceps (Catalog 5008) were distributed with incorrect expiration dates that extend shelf life beyond the device's actual safe use period. Affected units with lot numbers ending in 'R' were distributed from March 2018 to September 2020.

    Product
    Hobbs Medical Grasping Forceps Catalog Number: 5008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2023·2022-10-19

    Hobbs Scope Introducer Recalled for Incorrect Label Expiration Date

    Hobbs Medical is recalling 140 units of its Hobbs Scope Introducer due to incorrect label expiration dates that extend the shelf life. Affected devices were distributed in the US and internationally from March 2018 to September 2020.

    Product
    Hobbs Scope Introducer Catalog Number: 4650
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0010-2023·2022-10-19

    Hobbs Medical Spray Catheter Recalled for Incorrect Expiration Date

    Hobbs Medical is recalling Spray Catheter devices due to incorrectly labeled expiration dates that extend shelf life beyond the actual safe-use period. The recall affects 275 units distributed between March 2018 and September 2020.

    Product
    Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0064-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent recalled for incorrect expiration date

    Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on labels that extend perceived shelf life beyond actual device longevity.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6582
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0066-2023·2022-10-19

    Freeman Pancreatic Stent Recall: Incorrect Expiration Date on Device Labels

    Freeman Pancreatic Flexi-Stents with incorrect expiration dates on labels may be used beyond their validated shelf life. The recall affects devices distributed in the US and five other countries from March 2018 through September 2020.

    Product
    Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541
    Category
    Medical Device
    Distribution
    Distributed nationwide