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.

14576–14600 of 20364

  • HighFDA (Devices)·Z-0931-2023·2023-01-18

    Stradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk

    Stradis Healthcare is recalling Foley Catheter Insertion Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 920 units distributed across multiple US states.

    Product
    Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0108-2023·2023-01-18

    Compounded Injectable Drug Recalled Due to Lack of Sterility Assurance

    Northern VA Compounders has recalled QuadMix Super 002 injectable medication due to lack of assurance of sterility. The affected lot is distributed nationwide.

    Product
    QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2023·2023-01-18

    Surgical Craniotome Attachment Ball Bearings Have Detached During Surgery

    The Anspach 7.5 cm Large Rotating Craniotome Attachment ball bearings have come out during surgery or device removal. Failure to follow proper inspection intervals may result in serious patient injury.

    Product
    7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2023·2023-01-18

    Henry Shein Sterile Gloves Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling Henry Shein sterile gloves due to pinhole leaks in outer packaging that may compromise sterility. The recall affects approximately 21,755 units distributed nationwide.

    Product
    Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2023·2023-01-18

    Neonatal PICC Tray Recalled Due to Potential Sterility Breach

    Vital Care Products' Neonatal PICC Tray kits may have pinhole leaks in the outer bag near the seal, potentially compromising sterility. Affected units were distributed nationwide.

    Product
    Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2023·2023-01-18

    FDA Recalls BIOSTOP G Cement Restrictor Due to Elevated Endotoxin Levels

    DePuy Ireland is recalling all lots of BIOSTOP G Bioresorbable Cement Restrictor because endotoxin levels exceeded FDA regulatory guidance. Endotoxins can cause inflammatory responses, from mild fever to potential organ damage.

    Product
    BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0950-2023·2023-01-18

    IMMULITE 2000 Thyroglobulin Diagnostic Kit Accuracy Issues

    Siemens is recalling 7,543 kits of IMMULITE 2000 Thyroglobulin diagnostic tests due to potential accuracy and precision issues affecting diagnostic reliability.

    Product
    IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2023·2023-01-18

    HCT MAX BARRIER PICC Insertion Tray Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling HCT MAX BARRIER PICC Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. No illnesses have been reported, but affected healthcare facilities should immediately discontinue use of the affected lot.

    Product
    HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2023·2023-01-18

    DeRoyal surgical procedure pack recalled for sterile barrier defect

    DeRoyal is recalling certain surgical procedure packs containing Medtronic non-absorbable sutures due to a manufacturing error that may breach the sterile barrier protecting the surgical field.

    Product
    DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2023·2023-01-18

    QuadMix Plus Injectable Medication Recalled for Lack of Sterility Assurance

    Northern VA Compounders is recalling QuadMix Plus injectable medication due to lack of assurance of sterility. The recall affects 78 vials distributed nationwide.

    Product
    QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2023·2023-01-18

    Syringe Kit Recall: Potential Sterility Breach from Outer Bag Leaks

    Stradis Healthcare is recalling HCT 12 CC Syringe Kits due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 112,675 units distributed nationwide.

    Product
    HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0114-2023·2023-01-18

    TriMix Injection Recalled Due to Sterility Assurance Failure

    Northern VA Compounders is recalling TriMix Injection due to lack of assurance of sterility. The affected lot (11142022@11, exp. 12/29/2022) was distributed nationwide. No illnesses have been reported.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0123-2023·2023-01-18

    TriMix Plus 002 Injectable Medication Recalled for Sterility Concerns

    FDA is recalling TriMix Plus 002, a compounded injectable medication, due to lack of assurance of sterility. The affected lot may not meet required sterility standards.

    Product
    TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0253-2023·2023-01-18

    Sanders Dark Chocolate Maple Sea Salt Caramel Recalled for Foreign Material

    Sanders Candy LLC is recalling Sanders Dark Chocolate Maple Sea Salt Caramel due to brush bristles found in the product. Consumers should not consume affected units.

    Product
    Sanders Dark Chocolate Maple Sea Salt Caramel: No UPC 6oz. foil bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2023·2023-01-18

    Adult Craniotome Attachment Recalled for Ball Bearing Failure Risk

    The ANSPACH CRANI-A Adult Craniotome Attachment is recalled because ball bearings can separate during use or removal, creating an intra-operative hazard. The Anspach Effort, Inc. is recalling 6,059 units distributed nationwide and internationally.

    Product
    6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0099-2023·2023-01-18

    Rocuronium Bromide Injection Recalled for Lack of Sterility Assurance

    Rocuronium Bromide Injection syringes from Nephron Sterile Compounding Center are being recalled because the manufacturer cannot verify the product is sterile. The recall affects approximately 38,830 pre-filled syringes distributed nationwide.

    Product
    Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2023·2023-01-18

    Compounded Injectable Medication Recalled Due to Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling QuadMix Standard 002 injectable medication because sterility of one lot cannot be assured. The recall affects 12 vials distributed nationwide.

    Product
    QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2023·2023-01-18

    Orthopedic Implant Cage Recalled for Incorrect Internal Material

    Specific lots of CoreLink FLXFIT 15 orthopedic implant cages contain stainless steel internal components instead of the specified titanium alloy. The 18 affected units were distributed nationwide.

    Product
    CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0252-2023·2023-01-18

    Sanders Dark Chocolate Peppermint Recalled for Cleaning Brush Bristles

    Sanders Dark Chocolate Peppermint Sea Salt Caramel is recalled nationwide and in Canada due to contamination with cleaning brush bristles. Products with Best By dates from October and December 2023 are affected.

    Product
    Sanders Dark Chocolate Peppermint Sea Salt Caramel: UPC 0-35900-30857-4 18OZ Tub UPC 0-35900-30919-9 32OZ Tub
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0251-2023·2023-01-18

    Sanders Milk Chocolate Sea Salt Pecan Cluster Recalled for Brush Bristles

    Sanders Candy LLC recalls Sanders Milk Chocolate Sea Salt Pecan Cluster due to foreign material—pieces of cleaning brush bristles—found in the product. The recall affects nearly 1 million units distributed nationwide and in Canada.

    Product
    Sanders Milk Chocolate Sea Salt Pecan Cluster: 0-35900-25550-2 .5OZ Individual Wrapped 0-35900-27486-2 25OZ Tub 0-35900-30971-7 18OZ Tub 0-35900-30170-4 7OZ Pouch
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2023·2023-01-18

    Source Administration Set medical device recalled for contamination

    The FDA has recalled 2,840 units of the Source Administration Set, a medical device used for PET imaging, due to contamination with black specks on needles.

    Product
    Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0117-2023·2023-01-18

    Injectable Compounded Drug Recall Due to Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling 525 vials of TriMix Plus 001 injectable medication nationwide due to lack of assurance of sterility. Patients who received this product should consult their healthcare provider.

    Product
    TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0124-2023·2023-01-18

    Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns

    Northern VA Compounders is recalling QuadMix Injectable due to lack of assurance of sterility. The FDA Class II recall affects compounded injectable medication distributed nationwide.

    Product
    QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0120-2023·2023-01-18

    Compounded QuadMix injectable recalled for sterility assurance concerns

    Northern VA Compounders PLLC recalled QuadMix Injectable nationwide due to lack of assurance of sterility. Patients who received this compounded medication should contact their healthcare provider immediately.

    Product
    QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2023·2023-01-18

    Adult Craniotome Ball Bearing Separation Risk During Neurosurgery

    The Anspach Adult Craniotome Large attachment ball bearings may separate during surgical removal or intra-operatively, potentially causing serious patient injury.

    Product
    Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide