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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10876–10900 of 13717

  • HighFDA (Devices)·Z-0096-2023·2022-10-26

    Laryngeal mask airway recalled for incorrect size marking

    Intersurgical Solus Standard size 3 laryngeal mask airways are marked with incorrect size 4 information, which may cause misuse or improper sizing of the airway device.

    Product
    Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0106-2023·2022-10-26

    Chest Tube Insertion Tray Recalled Due to Over-Sterilization of Suture Component

    Medline recalls CENTURION SnagFree Chest Tube insertion trays because a silk suture component was sterilized twice instead of once, potentially compromising its integrity. The affected lot contains 18 kits distributed in California and Texas.

    Product
    CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2023·2022-10-26

    Medical device assay may report falsely elevated lithium levels

    Siemens' Atellica CH Lithium diagnostic assay may falsely report elevated lithium levels, potentially leading to incorrect dose adjustments in patients on lithium therapy.

    Product
    Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
    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-0020-2023·2022-10-19

    Hobbs Posi-Stop Injection Needle Recalled for Incorrect Expiration Date Labeling

    Hobbs Medical is recalling Hobbs Posi-Stop Injection Needles with certain lot numbers because device labels display an incorrect expiration date, extending the product's indicated shelf life.

    Product
    Hobbs Posi-Stop Injection Needle Catalog Number: 4702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2023·2022-10-19

    COVID Test Kits Recalled for Incorrect Labeling and Device Incompatibility

    American Contract Systems is recalling COVID test kits incorrectly labeled for SARS-CoV-2 testing use. The 39,575 kits distributed in Pennsylvania should not be used with COVID devices.

    Product
    COVID Test Kit Nonsterile
    Category
    Medical Device
    Distribution
    1 state
  • 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-0060-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Recall Due to Incorrect Expiration Date

    Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on product labels. The incorrect dates extend the shelf life, potentially allowing use beyond the actual safe expiration.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6562
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2023·2022-10-19

    Medical device retrieval basket labels show incorrect expiration dates

    Hobbs Medical recalls the Helical Retrieval Basket due to labels displaying incorrect expiration dates that extend the device's shelf life. Affected units distributed worldwide from March 2018 to September 2020 may be used beyond their validated lifespan.

    Product
    Hobbs Helical Retrieval Basket Catalog Number: 4806
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Kits recalled for incorrect expiration dates

    Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits due to mislabeled expiration dates that may extend shelf life. Affected devices with lot numbers ending in R were distributed in the US and internationally from 2018-2020.

    Product
    Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0032-2023·2022-10-19

    Hobbs Helical Retrieval Basket Recall Due to Incorrect Expiration Date Label

    Hobbs Medical is recalling Hobbs Helical Retrieval Basket (Catalog Number 4830) due to an incorrect expiration date on the device label. Affected devices have lot numbers ending in 'R' and were distributed in the US from March 2018 to September 2020.

    Product
    Hobbs Helical Retrieval Basket Catalog Number: 4830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2023·2022-10-19

    Hobbs Medical Transbronchial Aspiration Needle Recalled for Incorrect Expiration Date

    Hobbs Medical recalls Transbronchial Aspiration Needle (Catalog 4621) for incorrect expiration dates extending shelf life. Affected devices distributed in the US and internationally from March 2018 to September 2020.

    Product
    Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2023·2022-10-19

    Hobbs Posi-Stop Injection Needle recalled for incorrect expiration date on label

    Hobbs Medical is recalling Posi-Stop Injection Needles (lot numbers ending in R) due to incorrect expiration dates on labels that extend shelf life. Affected devices were distributed in the US from March 2018 to September 2020.

    Product
    Hobbs Posi-Stop Injection Needle Catalog Number: 4718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0059-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent labeled with incorrect expiration dates

    Hobbs Medical is recalling Freeman Pancreatic Flexi-Stents with incorrect expiration dates on device labels that extend shelf life. Devices were distributed in the US and internationally from March 2018 to September 2020.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6548
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0081-2023·2022-10-19

    Prismaflex M Set Recall for Mistranslated Weight Restriction Instructions

    Baxter Healthcare is recalling Prismaflex M Sets (524,376 devices nationwide) due to a mistranslation in instructions for use that provides contradictory patient body weight restrictions for renal replacement therapy.

    Product
    Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0017-2023·2022-10-19

    Hobbs Transbronchial Aspiration Needle Recalled for Incorrect Expiration Date

    Hobbs Medical is recalling transbronchial aspiration needles with incorrect expiration dates on labels. The 18 affected units were distributed in the US, Canada, Austria, Belgium, Finland, and Norway from March 2018 to September 2020.

    Product
    Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2023·2022-10-19

    Hobbs Medical Polypectomy Snare Recalled for Incorrect Expiration Date

    Hobbs Medical is recalling Polypectomy Snare devices (Catalog Number 4564) due to incorrect expiration dates on labels that extend the stated shelf life. The 35 affected units, distributed in the US and select countries, may be used beyond their actual safe shelf life.

    Product
    Hobbs Medical Polypectomy Snare Catalog Number: 4564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0058-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Distributed with Incorrect Expiration Date

    Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on the device labels. Affected units distributed in the US and internationally from March 2018 to September 2020 may have been used beyond their actual safe shelf life.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6544
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0040-2023·2022-10-19

    Hobbs Biliary Pigtail Stent Kits Recalled for Incorrect Expiration Date Labels

    Hobbs Medical is recalling Biliary Pigtail Stent Kits for incorrect expiration dates on product labels that may extend shelf life. Affected kits were distributed nationwide and internationally between March 2018 and September 2020.

    Product
    Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
    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
  • 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-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-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