The Recall Desk

State

Massachusetts product recalls

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

About recalls in Massachusetts

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 Massachusetts 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.

14601–14625 of 20364

  • HighFDA (Food)·F-0250-2023·2023-01-18

    Sanders Milk Chocolate Sea Salt Caramels Recalled for Foreign Material

    Sanders Candy LLC is recalling Sanders Milk Chocolate Sea Salt Caramels due to potential cleaning brush bristles contamination. The product poses a choking and injury hazard.

    Product
    Sanders Milk Chocolate Sea Salt Caramels: UPC 0-35900-27636-1 36OZ Tub UPC 0-35900-25551-9 .5OZ Individual Wrapped UPC 0-35900-27436-7 28OZ Tub UPC 0-35900-27636-1 2 pack 36OZ Tub UPC 0-35900-30781-2 6OZ Pouch UPC 0-35900-30970-0 18OZ Tub UPC 0-35900-30986-1 18OZ Tub UPC 0-35900
    Category
    Food
    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 (Drugs)·D-0126-2023·2023-01-18

    TriMix Injection Recalled Due to Lack of Sterility Assurance

    Northern VA Compounders is recalling TriMix Injection due to inability to assure the product meets sterility standards required for injectable medications. The recall affects 2 vials distributed nationwide.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/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-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 (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-0924-2023·2023-01-18

    Pediatric Craniotome Recalled for Ball Bearing Detachment Risk

    The Anspach Effort, Inc. is recalling 6,059 Pediatric Craniotome units (CRANI-P-G1) because ball bearings in the CRANI-A attachment may detach during surgery, potentially causing serious patient injury.

    Product
    Pediatric Craniotome Ref:CRANI-P-G1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2023·2023-01-18

    Sterile EVA Medical Bags Recalled Due to Pinhole Leak Risk

    Stradis Healthcare recalls HCT 50mL sterile EVA bags due to potential pinhole leaks near the seal that could compromise sterility. Approximately 2,779 units were distributed nationwide.

    Product
    HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0105-2023·2023-01-18

    Injectable drug recalled due to lack of sterility assurance

    Northern VA Compounders PLLC recalls compounded injectable QuadMix Super 001 (56 vials) nationwide due to lack of assurance of sterility. Affected lot #11162022@7, expiration 12/31/2022.

    Product
    QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/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-0928-2023·2023-01-18

    BD Pyxis MedBank System may dispense wrong medication due to software error

    The BD Pyxis MedBank medication dispensing system has a software error that may cause the wrong medication to be loaded in a drawer compared to what the label shows, risking patient harm.

    Product
    BD Pyxis MedBank System - Product Label/labeling pending
    Category
    Medical Device
    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
  • HighFDA (Devices)·Z-0953-2023·2023-01-18

    Medtronic RadiaLux Lighted Retractor recalled for defective sterile pouch seal

    Medtronic is recalling 2,317 RadiaLux Lighted Retractor units due to defects in the sterile pouch seal that increase contamination risk and potential post-operative infection.

    Product
    RadiaLux Lighted Retractor (Pink), REF: 50-101-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2023·2023-01-18

    Large Craniotome Attachment Ball Bearings Risk Loosening During Surgery

    Ball bearings in The Anspach Effort's 7.5 cm Large Craniotome Attachment may come loose during removal or surgery, potentially causing serious patient injury. 6,059 units are affected worldwide.

    Product
    7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0102-2023·2023-01-18

    Mitomycin Injection Solution Recalled Due to Lack of Sterility Assurance

    Mitomycin Injection Solution manufactured by Northern VA Compounders PLLC is being recalled because sterility cannot be assured. Patients receiving this product should contact their healthcare provider.

    Product
    Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0930-2023·2023-01-18

    Medline CISION Sterile Surgical Blades Recalled for Sterile Packaging Breach Risk

    Medline Industries is recalling CISION Sterile Blades used in surgical procedures due to potential for the blade to puncture the sterile outer packaging, breaching sterility. No injuries reported.

    Product
    Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2023·2023-01-18

    Fluid Filter Transfer Kit Recalled Over Potential Sterility Breaches

    Stradis Healthcare is recalling approximately 1,175 Tacy Medical fluid filter transfer kits due to potential pinhole leaks in the outer bag that may compromise sterility. The kits were distributed nationwide in nine states.

    Product
    Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2023·2023-01-18

    Craniotome Attachment Ball Bearings May Separate During Surgery

    The FDA is recalling a surgical craniotome attachment after ball bearings can separate from the device. Failure to follow inspection protocols may result in serious patient injury during neurosurgery.

    Product
    6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2023·2023-01-18

    McCormick Medical Distribution PORT TRAY recalled for potential sterility breaches

    Stradis Healthcare is recalling McCormick Medical Distribution PORT TRAY units due to potential pinhole leaks in the outer bag that could compromise sterility. Affected units were distributed nationwide.

    Product
    McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2023·2023-01-18

    Prostaglandin E1 Injection Recall Due to Sterility Assurance Failure

    Northern VA Compounders has recalled Prostaglandin E1 Injection Solution due to lack of assurance of sterility in the compounding process. The affected lot was distributed nationwide.

    Product
    Prostaglandin (E1) Injection Solution, 10 mcg/ml, 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-0125-2023·2023-01-18

    Compounded Injectable Drug Recalled for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling 1,200 vials of BiMix STD 001 injectable nationwide due to lack of assurance of sterility. The compounded drug cannot be verified as sterile.

    Product
    BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/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-0118-2023·2023-01-18

    TriMix Injectable Recalled for Lack of Sterility Assurance

    Northern VA Compounders PLLC is recalling TriMix Injection (11.8mcg/18mg/0.6mg/mL) due to lack of assured sterility. Patients using affected vials should contact their healthcare provider immediately.

    Product
    TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/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-0122-2023·2023-01-18

    BiMix Injection Recalled for Lack of Assurance of Sterility

    Northern VA Compounders has recalled BiMix Injection due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider.

    Product
    BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/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-0949-2023·2023-01-18

    IMMULITE 2000 Thyroglobulin test kits recalled for reduced analytical sensitivity

    Siemens is recalling 717 IMMULITE 2000 Thyroglobulin test kits because they may not accurately measure thyroglobulin levels. Inaccurate results could affect monitoring of thyroid cancer patients.

    Product
    IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroi
    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