The Recall Desk

State

Massachusetts product recalls

72,940 recalls have nationwide distribution and so reach Massachusetts. 8,209 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total
8,209
Critical
1,171
Severe
2,013
Most recent
2026-09-09

Of the 8,209 recalls naming Massachusetts we have scored against our rubric, 1,171 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,013 (25%) are Severe.

These figures cover only the 8,209 recalls whose distribution notice names Massachusetts specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4376–4400 of 81149

  • HighFDA (Devices)·Z-0541-2026·2025-11-26

    Flow cytometers recalled over software that crashes during sample acquisition

    Beckman Coulter is recalling 25 DxFLEX Flow Cytometers because a software error crashes the system during acquisition on a patient sample when running a customer defined protocol.

    Product
    DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2026·2025-11-26

    Head and neck ENT kits recalled over smoke pencil activation defect

    Medline is recalling 3,078 head and neck, ENT and thoracotomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2026·2025-11-26

    Breast biopsy packs recalled over smoke pencils that may activate

    Medline is recalling 301 breast biopsy and mastectomy convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2026·2025-11-26

    Oncology software recalled because appended medication orders may mismatch the schedule

    Elekta is recalling four systems running MOSAIQ Oncology Information System builds 3.1.3 through 3.2.3.0 because appended wave medication orders may not match the intended schedule.

    Product
    MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0571-2026·2025-11-26

    Blood tubes recalled after being manufactured without the gel separator

    Greiner Bio-One is recalling 1,980,000 Vacuette 8 ml serum separator tubes because some were manufactured without the gel separator, which could yield erroneous assay results.

    Product
    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0504-2026·2025-11-26

    Luer tip caps recalled after trays failed routine biocompatibility testing

    Becton Dickinson is recalling 4,180,000 BD Luer Tip Caps after internal testing confirmed that certain device trays failed routine biocompatibility testing.

    Product
    BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0522-2026·2025-11-26

    Neuro shunt and laminectomy kits recalled over smoke pencil activation defect

    Medline is recalling 1,315 neurosurgery convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2026·2025-11-26

    Hemostasis valves recalled because the valve cap may remain depressed

    Merit Medical is recalling 217,141 PhD Hemostasis Valves because a manufacturing defect can leave the valve cap depressed, leading to potential leakage and possible hemorrhage.

    Product
    PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0530-2026·2025-11-26

    Neuro and joint kits recalled over smoke pencils that may activate

    Medline is recalling 40,151 neurosurgery, back and joint convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2026·2025-11-26

    Bone void implants recalled over an incorrect product name on packaging

    Berkeley Advanced Biomaterials is recalling 62 Tribio Implants 7.5mm x 40mm because the outer packaging carries an incorrect product name.

    Product
    Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2026·2025-11-26

    Heart pump kits recalled over corrosion at the backup battery connector

    Thoratec is recalling 29,059 HeartMate 3 Left Ventricular System kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2026·2025-11-26

    Circumcision packs recalled over smoke pencils that may activate unprompted

    Medline is recalling 120 Circumcision Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0557-2026·2025-11-26

    Blood gas capillary tubes recalled over an inadequate quality system

    ASP Global is recalling 397,000 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres, because they were manufactured under an inadequate quality system with unvalidated processes.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0161-2026·2025-11-26

    Moisturizing skin cream recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling DermaCerin Skin Protectant Moisturizing Cream because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0159-2026·2025-11-26

    Bromocriptine capsules recalled after an out of specification impurity result

    Zydus Pharmaceuticals is recalling 36,624 bottles of Bromocriptine Mesylate Capsules USP 5 mg after an out of specification result for the 2-Bromoergine impurity.

    Product
    BROMOCRIPTINE MESYLATE — BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0546-2026·2025-11-26

    Serum separator microtubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 64,850 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with clot activator and serum separator gel, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0554-2026·2025-11-26

    Amber clot activator microtubes recalled over an inadequate quality system

    ASP Global is recalling 1,500 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator in an amber microtube, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2026·2025-11-26

    Plasma separator tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 9,150 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0160-2026·2025-11-26

    No rinse wash cream recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 3,178 bottles of 4-N-1 Skin Protectant No Rinse Wash Cream because it was made at the same facility where other products were found contaminated.

    Product
    4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0558-2026·2025-11-26

    Large volume capillary tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 352,750 SAFE-T-FILL plastic blood gas capillary tubes, 230 microlitres with balanced heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0163-2026·2025-11-26

    Antiseptic lotion soap recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 7,736 tubes of DermaKleen antiseptic lotion soap because it was made at the same facility where other products were found contaminated.

    Product
    DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0172-2026·2025-11-26

    Perineal antiseptic recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 16,006 units of PeriGiene health care antiseptic because it was made at the same facility where other products were found contaminated.

    Product
    PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
    Category
    Drug
    Distribution
    Distributed nationwide