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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Minimum severity

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

Clear filters

1301–1325 of 13380

  • HighFDA (Devices)·Z-0955-2026·2025-12-24

    Rocket Chest Tube Procedure Tray Recalled for Misleading Securing Instructions

    Rocket Medical is recalling 246 units of the Rocket 20Fg Seldinger Catheter Procedure Tray due to misleading labeling and instructions that could lead to improper device securing and potential dislodgement during clinical use.

    Product
    Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied w
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0959-2026·2025-12-24

    FDA recalls Xpert BCR-ABL Ultra diagnostic test kits for potential inaccuracy

    Cepheid recalls 6,325 Xpert BCR-ABL Ultra test kits due to potential inaccuracies when samples contain elevated white blood cell counts. The diagnostic test is used to monitor chronic myeloid leukemia.

    Product
    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0946-2026·2025-12-24

    AART Chin Implants Recalled for Specification Deviations and Unapproved Distribution

    DSAART LLC is recalling AART Chin Implants because they were manufactured with deviations from specifications and distributed without required FDA premarket approval.

    Product
    Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 40
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0922-2026·2025-12-24

    Medline Sterile Kelly Forceps Recalled Due to Weak Packaging Seals

    Medline is recalling sterile Kelly forceps (Item DYNJ04048) distributed in CA, CO, IL, KS, and MI. Weak packaging seals may compromise sterility, increasing the risk of infection if the product is used.

    Product
    FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2026·2025-12-24

    Medical imaging software measurement bug compromises diagnostic accuracy

    Intelerad InteleShare medical imaging software versions 3.24.3–3.25.2 contain a bug causing inaccurate measurement values when multiplanar reconstruction and manual rotation are used together. This could compromise diagnostic accuracy and potentially lead to misdiagnosis.

    Product
    Intelerad InteleShare software, with ProViewer component
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0948-2026·2025-12-24

    AART Pectoral Implants Recalled for Specification Deviations and Unapproved Distribution

    DSAART LLC recalls 41 AART Pectoral Implants distributed without FDA approval and manufactured outside specifications. Units affected in multiple US states.

    Product
    Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 si
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0945-2026·2025-12-24

    FDA Recalls AART Gluteal Implants for Specification Deviations Without Premarket Approval

    DSAART LLC is recalling 118 AART Gluteal Implants distributed across US states due to specification deviations and lack of required FDA premarket approvals. Patients should contact their surgeon.

    Product
    Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0926-2026·2025-12-24

    Halyard General Laparoscopy Pack Recalled for Incomplete Header Bag Seal

    AVID Medical recalls Halyard General Laparoscopy Pack due to potential incomplete seals on the header bag that could compromise product sterility.

    Product
    Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0947-2026·2025-12-24

    AART Malar Implant Recalled for Manufacturing Defects and Missing FDA Approval

    DSAART LLC is recalling AART Malar Implants due to manufacturing deviations and lack of FDA premarket approval. No illnesses or injuries have been reported.

    Product
    Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-0957-2026·2025-12-24

    Smith & Nephew BIOSURE HA Screw recalled due to labeling error

    Smith & Nephew is recalling BIOSURE HA Screws (6MM x 20MM bone fixation fasteners) due to a labeling error. The recall affects 168 units distributed in the US and internationally.

    Product
    BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0961-2026·2025-12-24

    Abbott Alinity Chemistry Analyzer Software Corrected for Erroneous Results

    Abbott is correcting software in Alinity ci-series chemistry analyzers (versions 3.6.1 and lower) that could produce erroneous results for multiple analytes. The issue was discovered during internal testing.

    Product
    Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0943-2026·2025-12-24

    Copan DTT Treatment Reagent Recall Due to Lost Functionality

    Copan Italia is recalling 122,850 units of DTT treatment reagent used in respiratory specimen processing. The reagent's functionality in specimen fluidification cannot be guaranteed.

    Product
    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0938-2026·2025-12-24

    HemosIL SynthAFax Partial Thromboplastin Time Test Recalled for Manufacturing Defect

    Instrumentation Laboratory recalls HemosIL SynthAFax Partial Thromboplastin Time Tests (4,506 units) due to a manufacturing defect where recalled lots contained double the intended amount of preservative.

    Product
    HemosIL SynthAFax. Partial Thromboplastin Time Tests.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-0932-2026·2025-12-24

    Cardiosave Rescue Recalled for Instructions for Use Standards Update

    Datascope Corp. is recalling the Cardiosave Rescue. An addendum to the Instructions for Use corrects the reference standards for vibration and shock.

    Product
    Cardiosave Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0931-2026·2025-12-24

    Cardiosave Hybrid cardiac device instructions corrected for standards references

    Datascope Corp. is updating the Instructions for Use for the Cardiosave Hybrid to correct standards references in the Vibration and Shock Table. Approximately 11,470 units have been distributed in the US and internationally.

    Product
    Cardiosave Hybrid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0592-2026·2025-12-17

    FDA Recalls Draeger ErgoStar CM 55 Airway Connectors for Cracking

    Draeger's ErgoStar CM 55 airway connectors are being recalled due to cracks forming in the catheter mount hose. The defect affects respiratory connectivity in mechanical ventilation systems used for critically ill patients.

    Product
    ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0590-2026·2025-12-17

    Draeger ErgoStar CM 40 airway connectors recalled for hose cracks

    Draeger is recalling 14,420 ErgoStar CM 40 airway connectors worldwide due to cracks forming in the connector hose, which could compromise respiratory gas delivery to mechanically ventilated patients.

    Product
    ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0593-2026·2025-12-17

    ErgoStar CM 60 Airway Connector Recalled for Hose Cracking

    Draeger, Inc. is recalling the ErgoStar CM 60 airway connector (Model MP01860) due to multiple reports of cracks forming in the hose, which could lead to disconnection of the device from the patient during mechanical ventilation.

    Product
    ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0591-2026·2025-12-17

    ErgoStar CM 45 Airway Connector Recalled for Hose Cracks

    Draeger, Inc. is recalling ErgoStar CM 45 airway connectors due to cracks in the hose that may compromise respiratory gas delivery. Approximately 191,470 units are affected worldwide.

    Product
    ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0903-2026·2025-12-17

    Medline Quick Strip Adhesive Bandages Recall Due to Open Packaging Seals

    Medline is recalling Quick Strip Fabric Sterile Adhesive Bandages due to open seals in packaging that may compromise sterility. Approximately 6.9 million units distributed in the US, Guam, Canada, and UAE are affected.

    Product
    Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0904-2026·2025-12-17

    Medline Quick Strip Fabric Bandages recalled for potentially compromised sterility

    Medline is recalling all lots of Quick Strip Fabric Sterile Adhesive Bandages because open packaging seals may compromise product sterility. The recall affects 11,291,800 units.

    Product
    Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0907-2026·2025-12-17

    BD InLay Optima Ureteral Stent Kit Size Labeling Discrepancy

    C.R. Bard Inc is recalling the BD InLay Optima Ureteral Stent Kit (6 Fr. x 30 cm) due to a labeling discrepancy where the actual device size may not match the product label.

    Product
    BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2026·2025-12-17

    AMSCO 7053HP Washer/Disinfector recalled for electrical arcing hazard

    Steris is recalling 22 AMSCO 7053HP Washer/Disinfectors because a wire may shift and cause internal electrical arcing. While the arcing poses no electric shock risk, healthcare facilities should verify if they have affected units.

    Product
    AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2026·2025-12-17

    Bard InLay Optima Ureteral Stent Recalled Due to Labeling Size Discrepancy

    C.R. Bard is recalling 116 units of Bard InLay Optima Size 6 Fr. x 14 cm Ureteral Stent Kits because the actual stent size may not match the product label.

    Product
    Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
    Category
    Medical Device
    Distribution
    Distributed nationwide