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.

10351–10375 of 20199

  • HighFDA (Devices)·Z-0905-2024·2024-02-07

    Knee replacement inserts recalled due to material oxidation risk

    P7 knee replacement inserts may contain UHMWPE material over 5 years old that has developed oxidation, potentially degrading the material's properties. Patients should consult their healthcare provider.

    Product
    P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2024·2024-02-07

    Orthopedic surgical kits recalled for unassessed external component sterilization

    American Contract Systems recalls 5,524 orthopedic surgical kits due to unassessed sterilization of external components that may lose functionality, drug efficacy, or have excess sterilization chemical residue.

    Product
    Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2024·2024-02-07

    Ophthalmic procedural kits recalled due to inadequate sterilization validation

    American Contract Systems is recalling 940 ophthalmic surgical kits nationwide due to undocumented components that may lack functionality, drug efficacy, or contain elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2024·2024-02-07

    Urological procedural kits recalled due to sterilization defects

    American Contract Systems recalled 1,031 urological procedure kits nationwide due to sterilization process defects. Components may have damaged functionality, reduced drug efficacy, or elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica is recalling knee replacement implants manufactured with UHMWPE material over 5 years old due to potential oxidation that could affect material properties.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2024·2024-02-07

    Knee Replacement Component Recalled Due to Raw Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2024·2024-02-07

    Philips Achieva 3.0T MRI Coil Seal Adhesive May Fail, Risking Patient Injury

    The Quadrature Body Coil seal adhesive in Philips Achieva 3.0T MRI scanners may fail, creating sharp edges that can injure patients. All units with model numbers 781277, 781177, 781278, 781344, and 781345 are affected.

    Product
    Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2024·2024-02-07

    Knee Replacement Implant Recalled Due to Potential Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant performance.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2024·2024-02-07

    Knee replacement implants recalled for potential material degradation

    Howmedica Osteonics Corp. is recalling DURATION Plastic Patella knee replacement implants due to potential oxidation in UHMWPE raw material over 5 years old, which may affect implant durability.

    Product
    DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2024·2024-02-07

    Obstetrical and Gynecological Surgical Kits Recalled for Sterilization Assessment Defects

    American Contract Systems is recalling 1,020 obstetrical and gynecological surgical kits because components were sterilized without documented assessment of their suitability to the process, potentially causing loss of functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2024·2024-02-07

    Knee replacement implant insert recalled due to material degradation risk

    Howmedica Osteonics Corp. is recalling a knee replacement implant insert due to potential material oxidation. UHMWPE raw material over 5 years old may develop elevated oxidation levels, affecting implant properties.

    Product
    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
    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-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
  • HighFDA (Devices)·Z-0889-2024·2024-02-07

    Total Knee Replacement Component Recalled Due to Oxidation Risk

    Howmedica Osteonics Corp. is recalling SCORPIO Total Knee replacement components from specific manufacturing batches due to potential oxidation in raw materials over 5 years old. Oxidation can impact the material's properties.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2024·2024-02-07

    Knee replacement tibial insert recalled due to material oxidation risk

    Howmedica Osteonics Corp. is recalling DURATION knee replacement tibial inserts manufactured with raw materials over 5 years old that have developed oxidation. Oxidation can degrade the material's structural properties, affecting implant performance.

    Product
    DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
    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-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-0822-2024·2024-02-07

    Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment

    American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.

    Product
    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2024·2024-02-07

    Knee Replacement Implant Component Recalled for Material Degradation Risk

    Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella components due to potential oxidation in raw materials over 5 years old. No illnesses have been reported.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2024·2024-02-07

    Cardiac surgical kits recalled due to improper sterilization exposure

    American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.

    Product
    Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2024·2024-02-07

    Custom Procedural Convenience Kits Recalled for Sterilization Validation Failure

    American Contract Systems is recalling 244 custom procedural kits (Baby PICC, Pediatric PICC, and PORT PACK) distributed nationwide. Components subjected to sterilization without proper validation documentation may have reduced functionality or elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2024·2024-02-07

    Medical sterilization chemical integrators recalled due to labeling discrepancy

    TERRAGENE S.A. is recalling over 36,000 chemical integrator strips used to verify sterilization in healthcare settings because the instructions distributed with the products don't match the FDA-cleared instructions for use.

    Product
    Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
    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-0844-2024·2024-02-07

    Surgilon Braided Nylon Sutures Recalled for Excessive Gamma Sterilization

    Covidien LP recalls specific lots of Surgilon Braided Nylon sutures sterilized with excessive gamma radiation, which may weaken the sutures and cause wound complications.

    Product
    Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
    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