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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9276–9300 of 27441

  • 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-0113-2023·2022-10-26

    Reusable Oral Syringe Recalled for Unapproved Plunger Material

    Medicina UK Ltd is recalling Reusable Oral Syringes because plungers were manufactured from unapproved polyethylene instead of the specified polypropylene material.

    Product
    Medicina Reusable Oral syringe 5ml Code: OTH05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2023·2022-10-26

    MitraClip Clip Delivery System Recalled for Locking Malfunctions

    Abbott Vascular is recalling MitraClip Clip Delivery System devices due to observed increases in clip locking malfunctions that can lead to recurrence of mitral regurgitation, device embolization, or tissue injury.

    Product
    Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW US/CDS0701-XTW.
    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-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-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-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-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-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-0100-2023·2022-10-26

    Synthes SPEED implant recall: drill guide size mismatch in surgical kit

    Synthes is recalling SPEED 9X10X10mm surgical implant kits nationwide due to an incorrect-size drill guide that will not properly prepare bone for the implant, creating potential for bone damage.

    Product
    SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2023·2022-10-26

    Abbott MitraClip and TriClip Clip Delivery Systems: Locking Malfunction Risk

    Abbott is recalling MitraClip and TriClip Clip Delivery Systems due to clip locking malfunctions. Failed procedures may result in mitral regurgitation recurrence, device embolization, or tissue injury.

    Product
    Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW, Mi
    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-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-0099-2023·2022-10-26

    Surgical Implant Kit Recall: Incorrect Drill Guide Included

    Synthes surgical implant kits are being recalled because they contain an incorrect size drill guide that cannot properly prepare the bone for the implant, creating a risk of bone damage during surgery.

    Product
    SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
    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-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-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-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-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, TriCli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2023·2022-10-26

    N Antiserum to Human IgG Fails High-Dose Hook Effect Performance Standards

    Siemens N Antiserum to Human IgG reagent batches are not meeting performance standards for high-dose immunoassay testing. The issue affects 10,201 packs distributed nationwide and may result in inaccurate diagnostic test results.

    Product
    N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
    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-0056-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Medical Device Recalled for Mislabeled Expiration Date

    Hobbs Medical recalls Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates that extend shelf life, affecting devices distributed in the US and five other countries from 2018 to 2020.

    Product
    Freeman Pancreatic Flexi-Stent Catalog Number: 6534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0053-2023·2022-10-19

    Freeman Pancreatic Flexi-Stent Kits Recalled for Incorrect Expiration Dates

    Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits due to labeling errors showing incorrect expiration dates that extend the shelf life of affected devices.

    Product
    Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519
    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-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