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.

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9376–9400 of 40056

  • HighFDA (Devices)·Z-2401-2023·2023-08-23

    UroPass Ureteral Access Sheaths Recalled for Dilator Tip Breakage

    Olympus is recalling UroPass Ureteral Access Sheaths because dilator tips may break during surgical procedures or while in the package. The recall affects 9,520 units manufactured in 2018 and 2019.

    Product
    UroPass Ureteral Access Sheaths, 5 pieces/box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2421-2023·2023-08-23

    Surgical Clamp Recall: Rotation Knob May Crack or Break

    Snowden-Pencer endoscopic surgical clamps may have rotation knobs that crack or break due to manufacturing defect. Lot B23 units should not be used.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2415-2023·2023-08-23

    Snowden-Pencer Surgical Grasper Recalled for Cracking Rotation Knob

    Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS Diamond-Touch Grasper surgical tool due to defects in the rotation knob adhesive that may cause cracking or breaking during use.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2422-2023·2023-08-23

    Endoscopic Surgical Clamp Recalled Due to Potential Rotation Knob Failure

    Carefusion is recalling specific lots of Snowden-Pencer MIS endoscopic surgical clamps due to potential cracking or breaking of the rotation knob caused by incorrect adhesive use during manufacturing.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2405-2023·2023-08-23

    Hip Screw Labeled as Wrong Size: 30mm Screws Mislabeled as 25mm

    Conformis hip screws measuring 30mm have been mislabeled as 25mm, creating risk of incorrect surgical implantation. The recall affects 25 units distributed across nine states.

    Product
    CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2407-2023·2023-08-23

    Centurion FMS Pak Recalled Due to Patient Injury Risk from Plastic Debris

    Alcon Research recalls the Centurion FMS Pak following reports of patient injury during procedures. Plastic debris can result from over-tightening with the included plastic wrench.

    Product
    Centurion FMS Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2419-2023·2023-08-23

    Surgical clamp rotation knob may crack or break due to manufacturing defect

    Specific lots of Snowden-Pencer surgical clamps may have rotation knobs that crack or break due to incorrect adhesive use in manufacturing. Eight units with lot numbers L22, B23, or C23 distributed in the US and Canada are affected.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2412-2023·2023-08-23

    Medtronic ventricular catheter system recalled due to incorrect labeling expiration date

    Medtronic is recalling 44 units of the Duet External Drainage and Monitoring system because the product labels contain an incorrect expiration date. The affected lot (226632942) was distributed nationwide.

    Product
    Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2023·2023-08-16

    Olympus LF-P Tracheal Intubation Fiberscope Sterilization and Compatibility Update

    Olympus is updating labeling for 686 LF-P fiberscopes to clarify they are no longer compatible with OER reprocessors and specify new 100% ETO sterilization protocol.

    Product
    Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2355-2023·2023-08-16

    LINK MP Hip Stem Trial Instruments difficult to remove after implantation

    The LINK MP Monoblock hip stem trial instruments may require increased force to remove after implantation, potentially prolonging surgery or requiring modification of the surgical procedure.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2366-2023·2023-08-16

    Medline Total Hip Kit Recalled for Expired Prep Solution

    Medline is recalling the Total Hip Kit (REF DYNJ903275S) because the included prep solution expires before the kit itself expires. Sixteen kits with lot code 23CDC733 were distributed nationwide.

    Product
    Total Hip Kit, REF DYNJ903275S; surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2023·2023-08-16

    LINK MP Monoblock Hip Stem trial instruments recalled for increased removal difficulty

    Waldemar Link GmbH recalled LINK MP Monoblock hip stem trial instruments (Size 23) nationwide due to increased force required for removal post-impaction, potentially prolonging surgery time.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2023·2023-08-16

    LINK MP Monoblock Hip Stem Trial Instruments May Require Increased Removal Force

    LINK MP Monoblock Hip Stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery for affected patients.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2351-2023·2023-08-16

    Hip implant trial stem: increased removal force may extend surgery

    Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments due to increased force required for removal during surgery, which may prolong the procedure or require modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2356-2023·2023-08-16

    LINK MP Monoblock Hip Stem Trial Instruments Difficult to Remove After Impaction

    Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments because they may require increased force to remove after impaction, potentially prolonging surgery or requiring procedural modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2345-2023·2023-08-16

    Hip Stem Trial Implant May Require Excessive Force During Removal

    A trial hip stem implant may require excessive force to remove after insertion during surgery, potentially prolonging the procedure or requiring surgical modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2352-2023·2023-08-16

    LINK MP Hip Stem trial instruments may require increased removal force during surgery

    LINK MP Monoblock hip stem trial instruments may require increased force to remove during surgery, potentially prolonging procedures or requiring surgical modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2344-2023·2023-08-16

    Olympus Endoscope Reprocessor Labeling Revised for Compatibility and Sterilization Parameters

    Olympus is revising labeling for its OER-Elite, OER-Pro, and OER-Mini endoscope reprocessors due to incompatible endoscope models and incorrect sterilization parameters in previous labeling. The revisions remove two endoscope models from the compatibility list and correct gas sterilization concentration requirements.

    Product
    Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2393-2023·2023-08-16

    Ellacor System recalled for bearing adhesive defect risk

    The FDA is recalling 127 Ellacor System devices for a potential bearing adhesive failure in the handpiece. The defect could cause core overlap, leading to prolonged healing and scarring.

    Product
    ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2359-2023·2023-08-16

    Siemens ARTIS Icono Biplane Angiography Systems Thermal Cable Connector Defect

    Siemens recalls ARTIS icono biplane angiography systems with defective cable connectors that may cause thermal overload, burning smell, and loss of imaging functionality during clinical procedures.

    Product
    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2023·2023-08-16

    Olympus VISERA Tracheal Videoscope reprocessor compatibility and sterilization procedure revision

    Olympus is revising labeling for the VISERA Tracheal Intubation Videoscope to correct equipment compatibility information and update sterilization procedures. The device is no longer compatible with OER-Pro, OER-Elite, and OER-Mini reprocessors; sterilization and cleaning procedures have changed significantly.

    Product
    VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2023·2023-08-16

    VITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells

    ORTHO-CLINICAL DIAGNOSTICS is recalling VITROS Troponin I ES Reagent Pack due to potential incorrect wells that could generate false negative diagnostic results. Lot 4800 with expiration 10-Jun-2023 is affected.

    Product
    VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2023·2023-08-16

    Hip stem trial instruments recalled due to excessive removal force

    LINK MP Monoblock hip stem trial instruments may require excessive force to remove after impaction, potentially prolonging surgery or requiring procedural modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2360-2023·2023-08-16

    Angiography systems recalled due to thermal overload in cable connectors

    Siemens ARTIS icono floor angiography systems may experience thermal overload in cable connectors during fluoroscopy, causing burning smell and loss of imaging capability. The recall affects 7 units worldwide.

    Product
    ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2023·2023-08-16

    Philips MR 7700 Magnetic Resonance System Smoke Detector Interlock Bypass

    Philips MR 7700 MRI systems can have their smoke detector interlock safety mechanism bypassed when power cycled after smoke detection, allowing continued operation despite potential fire hazards.

    Product
    MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
    Category
    Medical Device
    Distribution
    Distributed nationwide