The Recall Desk

State

Pennsylvania product recalls

20,304 recalls have nationwide distribution and so reach Pennsylvania. 0 additional recalls listed Pennsylvania specifically in their distribution scope.

About recalls in Pennsylvania

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Pennsylvania consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

11951–11975 of 20304

  • HighFDA (Devices)·Z-2364-2023·2023-08-16

    Medical Device Recall: UroLift Visual Obturator Weld Defect Risk

    The UroLift Visual Obturator has an improperly performed weld that may fracture during use, and the welded area can harbor contamination not removed by standard cleaning. Affected units should not be used.

    Product
    UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2395-2023·2023-08-16

    MR Imaging System Smoke Detector Interlock Vulnerable to Bypass via Power Cycling

    Philips Ingenia Elition X MR systems can have their smoke detection safety interlock bypassed by power cycling the equipment. This vulnerability could allow unsafe operation during hazardous conditions.

    Product
    Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2346-2023·2023-08-16

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

    Waldemar Link is recalling 24 LINK MP Monoblock Hip Stem trial instruments due to increased force required to remove them after impaction, which may prolong surgery or require procedure modification.

    Product
    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00
    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-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-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-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-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-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-2358-2023·2023-08-16

    FDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives

    Ortho-Clinical Diagnostics is recalling VITROS Troponin I ES Calibrators because reagent packs may contain incorrect wells that could produce false negative results. The recall affects 4,013 units distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Troponin I ES Calibrators
    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-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-2362-2023·2023-08-16

    Randox Urea Enzymatic Assay Recall: Falsely Low Test Results Risk

    FDA recalls Randox RX Series Urea test kits because carryover from prior LDL-cholesterol tests may produce falsely low results, up to 11% below accurate values, potentially delaying diagnosis.

    Product
    Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
    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-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-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
  • 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-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-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-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-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-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
  • ModerateFDA (Drugs)·D-1082-2023·2023-08-16

    Dofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity

    Sun Pharmaceutical recalls Dofetilide 500 mcg capsules nationwide due to out-of-specification results in content uniformity testing. Affected lot DNE0217A with expiration 01/2025 may not meet pharmaceutical specifications.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2343-2023·2023-08-16

    Olympus Endoscope Reprocessor OER-Mini Labeling Revised for Device Compatibility

    Olympus revised labeling for the OER-Mini endoscope reprocessor. The company removed LF-V and LF-P endoscopes from the list of compatible devices and updated sterilization procedures.

    Product
    Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2363-2023·2023-08-16

    Surgical Spinal Tap Device Recalled for Incorrect Laser Marking

    Medtronic is recalling Solera Awl Tip Tap surgical devices due to incorrect laser marking. Thirteen devices were distributed in Florida, Colorado, Indiana, South Carolina, Texas, and Utah.

    Product
    CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
    Category
    Medical Device
    Distribution
    Distributed nationwide