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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3351–3375 of 39987

  • LowFDA (Devices)·Z-2411-2025·2025-09-03

    X7-2 transducer probes recalled over useful life labelling clarification

    X7-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    X7-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2394-2025·2025-09-03

    S5-2 transducer probes recalled to add useful life labelling

    S5-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    S5-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2403-2025·2025-09-03

    V6-2 transducer probes recalled to clarify useful life in the field

    V6-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    V6-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2392-2025·2025-09-03

    S4-1 Lumify transducer probes recalled to define transducer useful life

    S4-1 Lumify Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    S4-1 Lumify Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2389-2025·2025-09-03

    S12-4 transducer probes recalled to clarify useful life in the field

    S12-4 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    S12-4 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2326-2025·2025-08-27

    ENDOTAK RELIANCE leads with 4-SITE connector recalled over coil calcification

    ENDOTAK RELIANCE G/SG defibrillation leads with the 4-SITE connector are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.

    Product
    ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2327-2025·2025-08-27

    RELIANCE 4-FRONT defibrillation leads recalled over rising LVSI measurements and coil calcification

    RELIANCE 4-FRONT defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils, which may lead to early lead replacement.

    Product
    RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2328-2025·2025-08-27

    Hamilton C6 ventilators recalled over circuit board defect interrupting ventilation

    Hamilton C6 ventilators are recalled over a mechanical defect on a printed circuit board that may cause the device to fail at startup or interrupt ventilation during use. 1,040 systems are affected.

    Product
    Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2325-2025·2025-08-27

    ENDOTAK RELIANCE defibrillation leads recalled over coil calcification and rising LVSI

    ENDOTAK RELIANCE G/SG transvenous defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.

    Product
    ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2025·2025-08-27

    Electrosurgical generators recalled over system error causing reboots during use

    The ESG-410 Electrosurgical Generator is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 155 units are affected.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2344-2025·2025-08-27

    OtoLase starter kits recalled over potentially unsterilized product labeled as sterile

    OtoLase Starter Kits, UPN AC-2003748, batches 32644549 and 32769567, are recalled because finished product labeled as sterile may not have been sterilized. 13 units are affected.

    Product
    OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2340-2025·2025-08-27

    Deep brain stimulation burr hole kits recalled over retaining clip closing resistance

    Burr Hole Cover Kits used with the Vercise Deep Brain Stimulation System are recalled because resistance closing the retaining clip may cause procedural delay or lead migration requiring further surgery. 24,583 units are affected.

    Product
    Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2339-2025·2025-08-27

    Legacy electrosurgical generators recalled over system error triggering repeated device reboots

    The ESG-410 Legacy Electrosurgical Generator, model WA91307C, is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 434 units are affected.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2336-2025·2025-08-27

    Estrone diagnostic kits recalled over rare falsely high or low results

    Estrone RIA kits, catalog number DSL8700, are recalled because certain lots may rarely give falsely high or falsely low patient results. 279 units are affected.

    Product
    Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2025·2025-08-27

    Bayonet injection needles recalled after showing elevated cytotoxicity in testing

    Bayonet Luer-Lock injection needles, models 50-353-23 and 50-345-23, are recalled because affected product showed elevated cytotoxicity values, which may present a risk of intolerance or allergic reaction.

    Product
    Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2025·2025-08-27

    Endoscopy video processors recalled over hot light guide and thermal injury risk

    Pentax Medical EPK-i8020c video processors are recalled after reports of darkened images, smoke-like steam and a hot endoscope light guide that may cause thermal injury to the patient's mucous membrane. 144 units are affected.

    Product
    Pentax Medical Video Processor; Model Number: EPK-i8020c;
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2335-2025·2025-08-27

    Calcium test slides recalled after calibration failures delayed patient results

    VITROS Chemistry Products Ca Slides, catalog number 145 0261, generations 67 and above, are recalled because calibration failures on VITROS XT systems delay calcium test results. 174,215 units are affected.

    Product
    VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2345-2025·2025-08-27

    ELISA sample tip racks recalled over internal label misidentifying tip type

    Dynex Agility Sample Tips, model 67910 lot 863366, are recalled because the internal rack label reads reagent tip rack, causing the instrument to misidentify the tips and preventing their use. 237 units are affected.

    Product
    Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2330-2025·2025-08-27

    Suture retention devices recalled with no reason stated in FDA record

    DRS Vascular is recalling 264 Q-Stop Suture Retention Devices. The FDA enforcement record for this action carries a placeholder in place of a stated reason for the recall.

    Product
    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2337-2025·2025-08-27

    Strep A test kits recalled after shipment to unlicensed purchasing customers

    Clearview Strep A Exact II Dipstick Respiratory Kits are recalled because a classification error in the inventory system sent devices to customers without the required license to buy them. 5 kits are affected.

    Product
    Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2181-2025·2025-08-20

    Manual resuscitators recalled because blocked manometer port may disable pressure gauge

    Ambu is recalling 87,156 SPUR II adult resuscitators because the manometer port may be blocked, leaving the manometer non-functional. The FDA classified the action as Class I.

    Product
    Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4
    Category
    Medical Device
    Distribution
    Distributed nationwide