The Recall Desk

State

Maine product recalls

20,364 recalls have nationwide distribution and so reach Maine. 0 additional recalls listed Maine specifically in their distribution scope.

About recalls in Maine

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 Maine 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.

14876–14900 of 20364

  • HighFDA (Devices)·Z-0543-2023·2022-12-21

    Surgical procedure trays recalled for incomplete outer-bag sealing

    Stradis Healthcare is recalling surgical procedure trays and kits due to manufacturing defects that may result in incomplete sealing of the outer bag, potentially compromising sterility. Affected products were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Vein, Item No.682-1732,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2023·2022-12-21

    Surgical Procedure Kits Recalled by Stradis Healthcare for Sealing Defect

    Stradis Healthcare is recalling surgical procedure kits for perioral surgery due to a manufacturing defect that may result in incomplete outer bag sealing. This could compromise the sterility of the kits.

    Product
    STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2023·2022-12-21

    Surgical Procedure Trays with Potentially Compromised Sterile Packaging

    Stradis Healthcare is recalling surgical procedure trays due to potentially incomplete outer bag sealing that may compromise product sterility. Affected units were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Phleb, Item No.682-1425,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2023·2022-12-21

    Medical Surgical Trays and Kits Recalled for Incomplete Outer Bag Sealing

    Henry Schein Blue Tail Custom Pack surgical procedure trays are being recalled because manufacturing issues may have caused incomplete sealing of the outer bag, potentially compromising sterility.

    Product
    HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2023·2022-12-21

    Diagnostic Kit Recall: Falsely Elevated Mold Allergen Test Results

    Siemens IMMULITE 2000 allergen testing kits may produce falsely elevated results for mold allergen-specific IgE, potentially leading to incorrect mold allergy diagnoses.

    Product
    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2023·2022-12-21

    Oral Surgery Trays Recalled for Incomplete Sealing of Sterility Bags

    Stradis Healthcare is recalling certain oral surgery trays because the outer packaging may be incompletely sealed, potentially compromising the sterility of the surgical instruments.

    Product
    STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2023·2022-12-21

    FDA recalls Henry Schein bone marrow kit for defective seal

    Henry Schein bone marrow kits may have incompletely sealed outer bags, compromising sterility. Affected units were distributed in the US and Canada.

    Product
    HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2023·2022-12-21

    Stradis Healthcare Major Extremity Surgical Kits Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling Henry Schein Major Extremity surgical kits due to incomplete outer bag sealing that could compromise kit sterility. Affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2023·2022-12-21

    Dental Surgical Pack Recalled Due to Incomplete Sterile Seal

    Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.

    Product
    Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2023·2022-12-21

    Stradis Healthcare Surgical Procedure Kits Recalled for Incomplete Sealing

    Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.

    Product
    STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0523-2023·2022-12-21

    Procedure Trays Recalled for Potential Sterility Breach Due to Incomplete Sealing

    Stradis Medical recalls Henry Schein procedure trays because the outer bag may be incompletely sealed, risking sterility breach. The trays were distributed nationwide and in Canada.

    Product
    HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0522-2023·2022-12-21

    Surgical Procedure Trays Recalled for Incomplete Sterile Barrier Sealing

    Stradis Medical recalls Henry Schein surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. No injuries reported.

    Product
    HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2023·2022-12-21

    Zimmer Recalls NexGen Stemmed Tibial Components Due to Higher Revision Rates

    Zimmer Inc. is recalling NexGen Option Stemmed Tibial Components due to clinically and statistically significant higher revision rates when used with specific femoral components. The components are being removed from inventory.

    Product
    NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2023·2022-12-21

    HENRY SCHEIN Amnio Trays Recalled for Incomplete Outer Bag Seal

    HENRY SCHEIN Amnio Trays (Item No. 570-3059) manufactured by Stradis Medical are being recalled because the outer bag may be incompletely sealed, potentially compromising the sterility of the medical kit.

    Product
    HENRY SCHEIN, Amnio Tray, Item No.570-3059,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2023·2022-12-21

    Stradis Healthcare catheter angiography kits recalled for defective sterile sealing

    Stradis Medical is recalling catheter angiography procedure kits with potentially incompletely sealed outer bags that may compromise the sterile integrity of the medical devices.

    Product
    HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0718-2023·2022-12-21

    Siemens allergy test kits recalled for false mold allergen reactivity results

    Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.

    Product
    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2023·2022-12-21

    Dental surgical kits recalled due to incomplete outer bag sealing

    Stradis Healthcare is recalling dental surgical procedure kits due to manufacturing issues that may result in incompletely sealed outer bags, potentially compromising kit sterility.

    Product
    STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2023·2022-12-21

    Medical Procedure Trays Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling 100 units of Henry Schein CATH PACK kits due to manufacturing defects that may leave outer bags incompletely sealed, potentially compromising sterility.

    Product
    HENRY SCHEIN, CATH PACK Item No.570-2789
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2023·2022-12-21

    Surgical Procedure Kits Recalled Due to Incomplete Outer Bag Sealing

    Stradis Healthcare is recalling Henry Schein Custom PK 2 surgical procedure kits due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility. The recall affects 27 units distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2023·2022-12-21

    Surgical Trays Recalled Due to Incomplete Bag Sealing

    Stradis Healthcare is recalling surgical trays due to incomplete outer bag sealing that may compromise sterility of the surgical kit.

    Product
    HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2023·2022-12-21

    Surgical Procedure Kits Recalled for Incomplete Outer Bag Seal

    Stradis Healthcare is recalling Varicosity Basic Pack surgical procedure kits (105 units) distributed in the US and Canada due to potentially incomplete outer bag sealing that may compromise sterility.

    Product
    STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2023·2022-12-21

    NexGen Stemmed Tibial Component Recalled Due to Higher Revision Rates

    Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.

    Product
    NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0513-2023·2022-12-21

    Medical and surgical procedure trays recalled for incomplete seal

    Stradis Medical recalls medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise kit sterility.

    Product
    HENRY SCHEIN, VEIN TRAY, Item No.570-2738,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2023·2022-12-21

    Stradis Healthcare Phlebectomy Pack Recall Due to Sterility Breach Risk

    Stradis Healthcare recalls its Phlebectomy Pack (Item No. 682-001) due to incomplete sealing of outer bags, which may compromise sterility of surgical kits distributed nationwide.

    Product
    STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2023·2022-12-21

    Stradis Healthcare surgical procedure trays recalled for incomplete packaging seals

    Stradis Medical is recalling medical and surgical procedure trays with incomplete outer bag sealing, which may compromise sterility. The recall affects 150 units distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide