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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

11626–11650 of 40095

  • HighFDA (Devices)·Z-0102-2023·2022-10-26

    ARROW Midline Catheter Kit Mislabeled with Wrong Device Type

    ARROW INTERNATIONAL Inc. is recalling an ARROW Pressure Injectable Arrowgard Blue Advance Midline Catheter Kit due to mislabeling. The package labels incorrectly specify a double-lumen 5.5 French catheter, but the kit contains a single-lumen 4.5 French catheter.

    Product
    ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2023·2022-10-26

    IV extension set recall for potential joint failure and leakage risk

    B. Braun is recalling CARESITE SMALLBORE EXT SET T-PORT 5 IN. devices due to potential bonded joint failure that could cause leakage or detachment during use. The malfunction may result in delayed therapy, bloodstream infection risk, and exposure to hazardous medications.

    Product
    CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0110-2023·2022-10-26

    Oral Tip Syringes Recalled Due to Unapproved Plunger Material

    Medicina Oral Tip Syringes are being recalled because the plunger component was made with polyethylene instead of the approved polypropylene material. No illnesses or injuries have been reported.

    Product
    Medicina Oral Tip Syringe 1ml Code: OT01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2023·2022-10-26

    ULTRASITE US04TL Extension Sets recalled for bonded joint failure risk

    B. Braun is recalling ULTRASITE Extension Sets because the bonded joint has a high probability of failure during use. Device failure could cause leakage, bloodstream infections, and delays in therapy.

    Product
    ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2023·2022-10-26

    Lithium diagnostic assay may display falsely elevated results on Atellica CH analyzer

    The Atellica CH Lithium_2 diagnostic assay may produce falsely elevated lithium readings on the Atellica CH 930 analyzer, potentially leading to incorrect medication dosage adjustments. No illnesses have been reported.

    Product
    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2023·2022-10-26

    Medicina Oral Tip Syringe Recall Due to Unapproved Plunger Material

    Medicina Uk Ltd is recalling 12,000 Oral Tip Syringes (Code: OT005) because the plunger component was manufactured with polyethylene instead of the approved polypropylene material. The syringes do not meet raw material specifications.

    Product
    Medicina Oral Tip Syringe 0.5ml Code: OT005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • HighFDA (Devices)·Z-0101-2023·2022-10-26

    DePuy Synthes Hammertoe Implants Recalled for Incorrect Drill Guide Size

    Synthes (USA) Products LLC is recalling 196 DePuy Synthes Hammertoe Continuous Compression Implants due to an incorrect drill guide size that will not properly prepare bone for the implant, creating potential for bone damage.

    Product
    DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2023·2022-10-26

    BD Vacutainer Blood Alcohol Testing Tubes Recalled for Analytical Interference

    BD Vacutainer blood collection tubes are recalled due to isobutylene contamination that may cause false positive results in blood alcohol testing.

    Product
    BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0093-2023·2022-10-26

    Siemens N Antiserum to Human IgG Recall for High-Dose Performance Failure

    Siemens Healthcare Diagnostics recalls N Antiserum to Human IgG reagent for laboratory analyzers because it does not meet expected High-Dose Hook Effect performance specifications for IgG measurements in certain sample types.

    Product
    N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2023·2022-10-26

    Medical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies

    Roche Molecular Systems recalls the cobas 5800 PCR testing instrument due to false positive and invalid results caused by anomalous baselines. This may lead to erroneous or delayed diagnoses.

    Product
    cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0091-2023·2022-10-26

    IV Extension Sets Recalled for Bonded Joint Failure and Leakage Risk

    B. Braun extension sets (Product Code 470169) are recalled due to high probability of bonded joint failure, which may cause leakage or detachment during use, risking bloodstream infections and medication exposure.

    Product
    Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2023·2022-10-26

    Synthes Orthopedic Implant Drill Kit Recall: Incorrect Drill Guide Size

    Synthes (USA) Products LLC is recalling 81 SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kits nationwide due to incorrect drill guide sizing. The defect could result in bone damage and incorrectly placed drill holes during orthopedic surgery.

    Product
    SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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