The Recall Desk

State

Massachusetts product recalls

72,968 recalls have nationwide distribution and so reach Massachusetts. 8,211 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total
8,211
Critical
1,171
Severe
2,013
Most recent
2026-09-16

Of the 8,211 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 8,211 recalls whose distribution notice names Massachusetts specifically. The 72,968 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5401–5425 of 81179

  • HighFDA (Devices)·Z-2590-2025·2025-09-24

    Foley catheter trays recalled because inserts describe the wrong catheter material

    SureStep Foley Tray Systems, REF A303414A lot NGJY3685, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.

    Product
    SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2575-2025·2025-09-24

    DxH 600 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 600 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2025·2025-09-24

    DxH 900 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 900 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0653-2025·2025-09-24

    Sodium chloride irrigation bags recalled over port misalignment allowing fluid leakage

    B. Braun 0.9% Sodium Chloride Irrigation USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 16,228 bags are affected.

    Product
    SODIUM CHLORIDE FOR IRRIGATION — SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2025·2025-09-24

    DxH 800 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 800 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2025·2025-09-24

    Heartstring III seal systems recalled over failures to load, deploy and seal

    Heartstring III Proximal Seal Systems, model HS-3045, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 126 units are affected.

    Product
    Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0648-2025·2025-09-24

    Chilaquiles meal packs recalled over undeclared Yellow No. 5 and 6

    Charge-Up Chilaquiles, 3.5 oz, lot 52061, is recalled because Yellow #5 and Yellow #6 are undeclared. 566 packages are affected.

    Product
    CHARGE-UP CHILAQUILES Traditional Mexican breakfast consisting of tortilla chips smothered in a spicy tomatillo salsa and beans, topped with egg and cheese. NET WT 3.5 OZ (100G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDER, CORN STARCH, MALTODEXT
    Category
    Food
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2578-2025·2025-09-24

    Distraction pins in five packs recalled over unvalidated shelf life

    Frontier Devices 14 mm Distraction Pins in 5 single packs are recalled because the labeling includes a shelf life that has not been validated. 2,700 units are affected.

    Product
    Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2585-2025·2025-09-24

    Blood gas EG6+ cartridges recalled for lacking updated premarket clearance

    i-STAT EG6+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 547,250 units are affected.

    Product
    i-STAT EG6+ cartridge. List Number: 03P77-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2560-2025·2025-09-24

    Lactate slides in 18-slide cartridges recalled over calibration failures delaying results

    VITROS Chemistry Products LAC Slides, catalog 8150112, from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,320 units are affected.

    Product
    VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0596-2025·2025-09-24

    Battle Hardener supplement cycle recalled over unapproved drug claims

    LG Sciences Battle Hardener Platinum Series complete 6 week cycle with PCT is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.

    Product
    LGSCIENCES BATTLE HARDENER PLATINUM SERIES COMPLETE 6 WEEK CYCLE WITH PCT LEGAL GEAR DIETARY SUPPLEMENT 17-PROANDRO pBOLD FORM-XT UPC 7 44890 94151 6 MADE FOR LG SCIENCES 6015-B UNITY DR. NORCROXX, GA 30071
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-2576-2025·2025-09-24

    Distraction pins in single packs recalled over shelf life that was not validated

    Frontier Devices 12 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 3,790 units are affected.

    Product
    Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0586-2025·2025-09-24

    Flexible joint formula capsules recalled over unapproved drug claims on label

    Formutech Nutrition Flexible Joint Formula with Cissus Quadrangularis, 240 capsules, lot 405310805, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.

    Product
    FORMUTECH NUTRITION FLEXIBLE JOINT FORMULA WITH CISSUS QUADRANGULARIS SUPPORTS TENDONS & MUSSCLES PROMOTES HEALTH CARTILAGE LUBRICATES JOINTS 240 Capsules UPC 7 97573 90884 1 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Food)·H-0592-2025·2025-09-24

    Pine bark tablets recalled over unapproved drug claims and misbranding

    Hi-Tech Pharmaceuticals Pine Bark, 60 tablets, lot C15Cl4, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.

    Product
    HI-TECH PHARMACEUTICALS PINE BARK SUPPORTS HEART HEALTH & CIRCULATION SUPPORTS CARDIOVASCULAR HEALTH FIGHTS OXIDATIVE STRESS 60 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02446 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Food)·H-0601-2025·2025-09-24

    Watermelon greens formula recalled over unapproved drug claims and misbranding

    PrimeNutrition Phytoform Fruits & Greens Formula in watermelon, 13.75 oz, lot 174271126, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.

    Product
    PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT WATERMELON NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPLEMENT UPC 6 38302 40905 6 Manufactured by: Prime Nutrition 6015-B Unity Drive Nor
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Food)·H-0589-2025·2025-09-24

    Fish oil soft gels recalled over unapproved drug claims on packaging

    Hi-Tech Pharmaceuticals Fish Oil, 90 soft gels, lot 517120551, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.

    Product
    HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MAY HELP WITH JOINT PAIN MAY IMPROVE COGNITIVE FUNCTION 90 SOFT GELS UPC 8 11836 02585 9 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-2580-2025·2025-09-24

    Distraction pins in double packs recalled over unvalidated shelf life labeling

    Frontier Devices 14 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated.

    Product
    Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0595-2025·2025-09-24

    Joint Help capsules recalled over unapproved drug claims on the label

    iForce Nutrition Joint Help dietary supplement, 120 capsules, lot 101330812, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.

    Product
    IFN iFORCE NUTRITION JOINT HELP HEALTHY JOINTS & LIGAMENTS DIETARY SUPPLEMENT 120 CAPSULES UPC 8 54503 00226 5 Manufactured By: iForce Nutrition 6015B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-2584-2025·2025-09-24

    Blood gas EG7+ cartridges recalled for lacking updated premarket clearance

    i-STAT EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.

    Product
    i-STAT EG7+ cartridge. List Number: 03P76-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2583-2025·2025-09-24

    Blood gas CG8+ cartridges recalled for lacking updated premarket clearance

    i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.

    Product
    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0654-2025·2025-09-24

    Double strength antibiotic bottles recalled over micro-organism on packaging coil

    Sulfamethoxazole and Trimethoprim Tablets, USP 800 mg/160 mg double strength, in 6, 10, 14 and 20-count bottles are recalled because a micro-organism was found on a lot of packaging coil.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0650-2025·2025-09-24

    Packaged chlorpromazine cartons recalled over micro-organism on packaging coil

    Chlorpromazine Hydrochloride Tablets, USP, 200 mg, in blister cartons from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 873 cartons are affected.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2581-2025·2025-09-24

    Sixteen millimetre distraction pins recalled over unvalidated shelf life labeling

    Frontier Devices 16 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 490 units are affected.

    Product
    Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0594-2025·2025-09-24

    Quercetin tablets recalled over unapproved drug claims and misbranding on label

    Hi-Tech Pharmaceuticals Quercetin, 120 tablets, lot C1612, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.

    Product
    HI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS CARDIOVASCULAR HEALTH 120 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02491 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    50 states