The Recall Desk

State

Pennsylvania product recalls

20,190 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.

9851–9875 of 20190

  • HighFDA (Devices)·Z-1228-2024·2024-03-13

    Medical device software defect may cause incorrect laboratory test results

    A software defect in VITROS XT 7600 diagnostic systems running version 3.8.1 causes quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient laboratory results.

    Product
    VITROS XT 7600 Integrated System, Catalog No. 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2024·2024-03-13

    Synthes RIA Tube Assembly Recalled for Unconfirmed Sterility

    Synthes is recalling 144 units of RIA Tube Assembly surgical instruments due to sterility failure. The devices cannot be confirmed as sterile and pose a risk of infection if used in orthopedic procedures.

    Product
    RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2024·2024-03-13

    Knee Implant Tibial Inserts Recalled for Sterile Packaging Breach

    Howmedica Osteonics recalls Triathlon knee implant tibial inserts (37 US units) due to potential packaging breaches of inner and outer sterile blisters that may compromise product sterility.

    Product
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2024·2024-03-13

    Medical Device Imaging Software May Calculate Incorrect Breast Measurements

    Synapse PACS Version 7.1.000US may produce incorrect measurements when Secondary Capture 2D images lack pixel spacing information in the DICOM header. The affected software is installed in healthcare facilities worldwide, including the United States and Puerto Rico.

    Product
    Synapse PACS - Version 7.1.000US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2024·2024-03-13

    Triathlon TS Plus tibial inserts recalled for potential packaging breaches

    Howmedica Osteonics Corp. is recalling Triathlon TS Plus tibial inserts due to potential breaches in sterile packaging that could compromise product sterility. Affected units were distributed nationwide and internationally.

    Product
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2024·2024-03-13

    Medical Device Recall: VITROS XT 3400 Chemistry System Software Defect

    Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.

    Product
    VITROS XT 3400 Chemistry System, Catalog No. 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2024·2024-03-13

    X3 Triathlon Orthopedic Insert Recalled Due to Potential Packaging Breaches

    Howmedica Osteonics recalls 143 units of the X3 Triathlon CS Insert No. 6 (10 mm) due to potential breaches in inner and outer sterile blister packaging that could compromise product sterility.

    Product
    X3 TRIATHLON CS INSERT NO 6 10 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2024·2024-03-13

    X3 Triathlon CS Insert Recalled for Potential Sterile Packaging Breach

    Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert due to potential breaches in the inner and outer sterile packaging. The breaches could compromise device sterility, affecting 132 units in the U.S. and 26 internationally.

    Product
    X3 TRIATHLON CS INSERT NO 3 10 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2024·2024-03-13

    Howmedica X3 Triathlon CS Insert Recalled for Packaging Defects

    Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert (Part No. 5531-G-709-E, Lot KA1Y71) due to potential inner and outer sterile blister packaging breaches. No injuries have been reported.

    Product
    X3 TRIATHLON CS INSERT NO 7 9 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2024·2024-03-13

    VITROS XT7600 System Aspiration Risk During Sample Processing

    Ortho-Clinical Diagnostics is recalling the VITROS XT7600 Integrated System due to potential aspiration from unintended sample containers during processing, which may result in erroneous test results. The recall affects 1,720 units distributed worldwide.

    Product
    VITROS XT7600 Integrated System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2024·2024-03-13

    TFNA Femoral Nail Recalled Due to Sterility Confirmation Issue

    Synthes is recalling 11 TFNA Femoral Nails due to sterility failures. The affected units worldwide cannot be confirmed as sterilized and pose infection risks to patients.

    Product
    TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2024·2024-03-13

    Orthopedic knee implant recalled for potential sterile packaging breaches

    Howmedica Osteonics Corp. is recalling the NO 3 Triathlon TS Plus Tibial Insert due to potential breaches in the sterile packaging. The breaches could compromise product sterility and safety.

    Product
    NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2024·2024-03-13

    Synthes Opal Intervertebral Cage Spinal Implant Recall: Sterility Not Confirmed

    Synthes is recalling 30 Opal intervertebral cage spinal implants (Lot 427P153) because sterility cannot be confirmed. Patients with these devices should contact their surgeon immediately.

    Product
    Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2024·2024-03-13

    MRI System Displays Incorrect Field Gradient Safety Values

    Canon Medical's Vantage Elan MRI system may display incorrect maximum Spatial Field Gradient values, potentially causing discomfort in patients with MR conditional devices.

    Product
    MRI system: Vantage Elan, Model: MRT-2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2024·2024-03-13

    Medical Device: VITROS 3600 immunodiagnostic system software defect may produce incorrect results

    A software defect in the VITROS 3600 Immunodiagnostic System may cause quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient test results.

    Product
    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2024·2024-03-13

    Synapse PACS Software Version 7.2.000 Measurement Error in Breast Imaging

    FUJIFILM's Synapse PACS Version 7.2.000 produces incorrect measurements in breast imaging when analyzing Secondary Capture 2D images lacking pixel spacing information. Affected healthcare facilities should discontinue use for breast imaging measurements.

    Product
    Synapse PACS - Version 7.2.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2024·2024-03-13

    Medical imaging software measurements incorrect in specific cases

    FUJIFILM's Synapse PACS Version 7.2.200 produces incorrect measurements when analyzing certain breast imaging scans without pixel spacing data. This measurement error could affect diagnostic accuracy.

    Product
    Synapse PACS - Version 7.2.200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1252-2024·2024-03-13

    FDA Recalls Apollo Onyx Delivery Microcatheter Due to Labeling Mismatch

    FDA is recalling Apollo Onyx Delivery Microcatheters distributed in the US with incorrect European labeling. The devices contain different indications for use than those approved for the US market.

    Product
    The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2024·2024-03-13

    Aesculap Disposable Trocar with Dilating Pin Recalled for Compromised Sterility

    Aesculap Inc is recalling Disposable Trocars with Dilating Pins (Product Code EK224SU) due to potentially damaged sterile blister packaging that may compromise sterility. Affected units were distributed in the US and Canada.

    Product
    DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2024·2024-03-13

    VITROS Diagnostic System Software Defect May Cause Erroneous Patient Results

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 systems with software defects in versions 3.8.0 and 3.8.1. The defect prevents quality control rules from being properly reported, which could cause erroneous patient test results.

    Product
    VITROS XT 7600 Integrated System, Catalog No. 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2024·2024-03-13

    Aesculap Disposable Trocars Recalled Due to Sterile Packaging Damage Risk

    Aesculap Inc is recalling disposable trocars with dilating pins (Product Code EK234SU) because their sterile blister packaging may be damaged, potentially compromising sterility. This Class II recall affects units distributed in the US and Canada.

    Product
    DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2024·2024-03-13

    Synthes 2.5MM Surgical Drill Bits Recalled Due to Unconfirmed Sterility

    Synthes (USA) Products LLC is recalling 30 units of 2.5MM sterile surgical drill bits (Lot 77P6506) because sterility cannot be confirmed. Non-sterile surgical instruments pose a risk of surgical site infection if used in orthopedic procedures.

    Product
    2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2024·2024-03-13

    RAPIDSORB IPS Battery Pack recalled due to unconfirmed sterility

    Synthes is recalling 10 units of RAPIDSORB IPS Battery Pack Sterile because the products cannot be confirmed as sterile. The affected lot was distributed worldwide to medical facilities. Patients should consult their healthcare provider about replacement options.

    Product
    RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
    Category
    Medical Device
    Distribution
    Distributed nationwide