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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9376–9400 of 13748

  • ModerateFDA (Devices)·Z-1616-2023·2023-05-31

    Olympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance

    Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.

    Product
    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1615-2023·2023-05-31

    ViziShot 2 Aspiration Needle recalled for manufacturing angle defect

    ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.

    Product
    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1632-2023·2023-05-31

    Siemens Atellica CH Toxicology Calibrator Reassignment Due to Positive Bias

    Siemens Healthcare Diagnostics is reassigning Atellica CH Toxicology Calibrators due to a positive bias. The affected calibrators were distributed in the US and internationally across multiple countries.

    Product
    Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Number (SMN): 11099440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1479-2023·2023-05-31

    Fluoroscopic imaging system may display incorrect radiation dose readings

    Siemens Luminos Agile Max fluoroscopic imaging systems may occasionally display incorrect radiation dose information under certain unlikely circumstances. The manufacturer states there is no impact on clinical workflow or diagnosis. The error only occurs in systems with a second overhead X-ray tube.

    Product
    Luminos Agile Max (VE10, VF10, VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1447-2023·2023-05-24

    Draeger VentStar Anesthesia Breathing Circuit Connections May Detach

    Draeger Medical recalls VentStar Anesthesia (N) 180 breathing circuits. Glued connections can loosen or detach during ventilation, potentially creating a critical disconnection risk.

    Product
    VentStar Anesthesia (N) 180, MP00333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1568-2023·2023-05-24

    ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss

    ICU Medical is recalling ASM Replacement Batteries due to a manufacturing defect from the battery supplier. Affected batteries may lose capacity and runtime earlier than expected during their lifecycle.

    Product
    ASM Replacement Battery, Component Number SUB0000594
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1449-2023·2023-05-24

    VentStar Watertrap breathing circuit connections may detach during ventilation

    Draeger Medical is recalling the VentStar Watertrap (N) 180 due to glued breathing circuit connections that may become loose or detach during ventilation, posing patient safety risk.

    Product
    VentStar Watertrap (N) 180, MP00363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1567-2023·2023-05-24

    ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss

    ICU Medical is recalling the ASM Replacement Battery due to a manufacturing defect from the battery supplier. The defect may cause batteries to lose capacity and experience decreased runtime earlier than expected.

    Product
    ASM Replacement Battery, Component Number SUB0000864
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1440-2023·2023-05-24

    Draeger VentStar Basic ventilator breathing circuit connections may detach during use

    Draeger Medical is recalling 325 VentStar Basic (P)180 ventilators because glued breathing circuit connections can become loose before or during ventilation, potentially causing partial or complete detachment of circuit pieces.

    Product
    VentStar Basic (P)180, MP00351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1445-2023·2023-05-24

    VentStar Breathing Bag Set Recalled for Loose Circuit Connections

    Draeger Medical is recalling VentStar breathing bag sets nationwide due to loose glued connections in the breathing circuit. Connections can detach before or during ventilation.

    Product
    VentStar breathing bag Set (P) 110, MP00384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1451-2023·2023-05-24

    VentStar Coax breathing circuit connections recalled for detachment risk

    Draeger Medical is recalling VentStar Coax (P) 150 breathing circuit components due to potentially loose glued connections that could detach during ventilation, affecting 280 units distributed nationwide.

    Product
    VentStar Coax (P) 150, MP00379
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1457-2023·2023-05-24

    Ventstar Coax 230 breathing circuit connections can detach during ventilation

    The FDA is recalling Draeger Medical's Ventstar Coax 230 breathing circuit components due to glued connections that can become loose and detach during ventilation, potentially compromising patient breathing support.

    Product
    Ventstar Coax 230, MP03376
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1565-2023·2023-05-24

    Replacement Battery in Plum 360 Infusion System Recalled for Capacity Loss

    ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.

    Product
    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1444-2023·2023-05-24

    Anesthesia Ventilator Breathing Circuit Connections May Detach During Use

    Draeger Medical is recalling 130 units of the VentStar Anesthesia WT ventilator due to a defect where glued breathing circuit connections may loosen or detach during ventilation, potentially compromising anesthesia delivery.

    Product
    VentStar Anesthesia WT (P)180, MP00374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1450-2023·2023-05-24

    Draeger VentStar Breathing Circuit Connections May Loosen During Use

    Draeger Medical is recalling the VentStar Bag Set because glued connections on the breathing circuit can become loose or detach during ventilation, potentially compromising respiratory support.

    Product
    VentStar Bag Set (N) 110, MP00383
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1446-2023·2023-05-24

    ID Circuit Basic breathing circuit recalled for loose glued connections

    Draeger Medical is recalling ID Circuit Basic breathing circuits due to glued connections that can loosen during ventilation, potentially causing partial or complete detachment of circuit pieces.

    Product
    ID Circuit Basic (P) 180, MP01340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1453-2023·2023-05-24

    Anesthesia Circuit Kit Coax 3 Connections May Detach During Ventilation

    Draeger Medical is recalling Anesthesia Circuit Kit Coax 3 units because glued connections can become loose or detach before or during ventilation. The recall covers 329,294 units distributed nationwide.

    Product
    Anesthesia Circuit Kit Coax 3, MP02732
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1441-2023·2023-05-24

    VentStar Basic ventilator breathing circuit connections may detach

    Draeger Medical is recalling 200 units of the VentStar Basic ventilator due to glued breathing circuit connections that can loosen or detach before or during ventilation.

    Product
    VentStar Basic (P)250, MP00352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1458-2023·2023-05-24

    Anesthesia Set Coax 180 Breathing Circuit Connection Risk

    Draeger Medical is recalling the Anesthesia Set Coax 180 because glued breathing circuit connections can become loose during ventilation, causing partial or complete detachment.

    Product
    Anesthesia Set Coax 180, MP03384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2023·2023-05-24

    Anesthesia circuit kit may detach during ventilation due to loose glued connections

    Draeger Medical is recalling its Anesthesia Circuit Kit Coax HEPA (720 units) because glued connections can become loose during ventilation, potentially causing partial or complete detachment that could interrupt oxygen delivery during surgery.

    Product
    Anesthesia Circuit Kit Coax HEPA, MP17102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1455-2023·2023-05-24

    Ventstar Coax 180 Ventilator Breathing Circuit Connections May Detach

    Draeger Medical is recalling 18,160 Ventstar Coax 180 ventilators because glued breathing circuit connections can become loose and detach during use, potentially disrupting oxygen delivery.

    Product
    Ventstar Coax 180, MP03374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1590-2023·2023-05-24

    Impella 5.5 with SmartAssist Catheter Recalled for Heightened Purge Leak Rate

    Abiomed is recalling 610 units of the Impella 5.5 with SmartAssist catheter due to a heightened complaint rate for purge leaks. This intravascular pump provides circulatory support during critical care.

    Product
    Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
    Category
    Medical Device
    Distribution
    Distributed nationwide