The Recall Desk

State

Pennsylvania product recalls

20,199 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.

10376–10400 of 20199

  • HighFDA (Devices)·Z-0946-2024·2024-02-07

    Achieva 1.5T MRI Coil Seal Adhesive May Fail Creating Sharp Edges

    Philips Achieva 1.5T MRI scanner components may experience coil seal adhesive failure, creating sharp edges that could injure patients. Affected devices have been distributed worldwide.

    Product
    Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2024·2024-02-07

    EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures

    Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.

    Product
    EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2024·2024-02-07

    Philips Achieva XR MRI Coil Seal Adhesive Failure Risk

    Philips Achieva XR MRI body coil seal adhesive may fail and create sharp edges that could injure patients. Affected units are being recalled.

    Product
    Achieva XR. Model (REF) Numbers 781153, 781253.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0845-2024·2024-02-07

    Surgical sutures recalled due to substandard gamma sterilization doses

    Covidien is recalling multiple surgical suture products because certain lots were sterilized with gamma doses exceeding approved levels. The excess radiation may reduce suture strength over time, potentially causing wound failure and bleeding.

    Product
    Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2024·2024-02-07

    Knee replacement poly insert recalled due to material oxidation risk

    Howmedica Osteonics recalled TRIDENT knee replacement poly inserts (Part 620-00-28J, Lot 38059601) due to potential UHMWPE material oxidation in components over 5 years old. Oxidation may affect material properties.

    Product
    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2024·2024-02-07

    Knee replacement devices recalled due to potential material degradation

    Howmedica Osteonics Corp. recalls knee replacement devices with UHMWPE components manufactured from raw material over 5 years old due to potential oxidation that may affect material properties.

    Product
    DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee implants (Lot Numbers 482LM8, HH43K7) manufactured with aged UHMWPE material. The raw material is over 5 years old and may develop oxidation that could affect the implant's material properties.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2024·2024-02-07

    Philips Achieva MRI Scanner Recall: Loose Coil Seals May Cause Skin Injury

    Philips is recalling Achieva 1.5T MRI scanners due to a seal adhesive defect on the body coil that may fail during scanning, creating sharp edges that risk skin injury including abrasions and lacerations.

    Product
    Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0882-2024·2024-02-07

    SCORPIO TS TIB INSERT Knee Replacement Components Recalled for Potential Material Degradation

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2024·2024-02-07

    EZDilate Fixed Wire Balloon Recalled for Device Failure and Foreign Body Risk

    Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.

    Product
    EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0860-2024·2024-02-07

    Philips Azurion 7 M20 FlexArm system recalled for software connectivity loss

    Philips Medical Systems recalls the Azurion 7 M20 FlexArm system due to a software issue causing loss of connectivity between the FlexArm and Maquet Magnus Table. The recall affects 28 systems worldwide.

    Product
    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2024·2024-02-07

    SCORPIO U-DOME PATELLA Knee Implants Affected by Material Oxidation Risk

    Certain SCORPIO U-DOME PATELLA knee replacement devices may experience material degradation due to aged raw material. The manufacturer is recalling affected units because material oxidation could compromise device durability and performance.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2024·2024-02-07

    Knee Implant Inserts Recalled Due to Potential Material Degradation

    Howmedica Osteonics is recalling SCORPIO TS TIB knee implant inserts (Part Number 72-4-0510) manufactured with UHMWPE material over 5 years old. The material may have elevated oxidation levels that could affect implant performance.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0924-2024·2024-02-07

    Knee Replacement Insert May Degrade from Oxidized Raw Material

    Howmedica Osteonics is recalling PS LIPPED TIBIAL INSERT ASSY DURACON knee replacement inserts manufactured with UHMWPE raw material over 5 years old. The aged material may develop elevated oxidation that could impact material properties.

    Product
    PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2024·2024-02-07

    Obstetrical Labor and Delivery Kits Recalled for Potential Functionality Loss

    American Contract Systems has recalled Labor and Delivery Packs because certain components may have lost functionality or efficacy due to unvalidated sterilization exposure.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2024·2024-02-07

    Knee implant component recalled due to potential material oxidation

    Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.

    Product
    SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2024·2024-02-07

    Knee replacement inserts recalled for potential material oxidation

    Howmedica Osteonics Corp. is recalling LEFT LARGE-PCA knee replacement inserts manufactured with raw material over 5 years old due to potential elevated oxidation levels that could affect material properties.

    Product
    LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2024·2024-02-07

    Cryo Module Tank Hose Assemblies Recalled for Material and Design Defects

    AtriCure recalls certain tank hose assemblies for Cryo Module equipment due to manufacturing defects. The units have incorrect inner tube material and missing required perforations on the outer sheathing.

    Product
    Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2024·2024-02-07

    Knee replacement implant recalled for potential material oxidation risk

    Howmedica Osteonics is recalling the DUR PCA MTK REV INS RT knee replacement implant manufactured with UHMWPE material over 5 years old. The material can develop elevated oxidation levels that may degrade its properties.

    Product
    DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2024·2024-02-07

    Aesculap Needle Holders Distributed With Incorrect Product Labels and Packaging

    Aesculap Inc. is recalling needle holder models that were distributed with incorrect product labels. The MB215R was labeled as MB362R and vice versa, which may cause procedural delays.

    Product
    MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2024·2024-02-07

    Knee replacement component recalled due to potential material oxidation

    Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica Osteonics is recalling a knee replacement patellar component that may have been manufactured with oxidized raw material. Products using UHMWPE over 5 years old can develop elevated oxidation and degraded material properties.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2024·2024-02-07

    Knee replacement patella component recalled due to material oxidation risk

    Howmedica Osteonics Corp. is recalling SCORPIO RECESSED PATELLA knee replacement components manufactured from UHMWPE raw material over 5 years of age, which may develop elevated oxidation affecting material properties.

    Product
    SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2024·2024-02-07

    Custom Surgical Convenience Kits May Lack Proper Sterilization Validation

    American Contract Systems, Inc. recalls surgical convenience kits whose added components may lack proper sterilization validation, potentially resulting in loss of functionality or retained sterilant residue.

    Product
    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V488000·2024-02-07

    Tesla Model S and Model X seat belts may detach in crash

    Tesla is recalling certain 2021-2023 Model S and Model X vehicles because front-row seat belts may not be connected properly to pretensioner anchors and could detach. A detached seat belt may fail to properly restrain an occupant during a crash.

    Product
    TESLA — 2023 TESLA MODEL S
    Category
    Vehicle
    Distribution
    Distributed nationwide