The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1451–1475 of 21710

  • ModerateFDA (Devices)·Z-0551-2026·2025-11-26

    Lithium heparin capillary tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 103,200 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0547-2026·2025-11-26

    Clot activator microtubes recalled over an inadequate quality system

    ASP Global is recalling 27,950 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2026·2025-11-26

    Sodium fluoride microtubes recalled over an inadequate quality system

    ASP Global is recalling 2,100 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with sodium fluoride, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0167-2026·2025-11-26

    Foaming hand soap recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 576 containers of Hand-E-Foam because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0564-2026·2025-11-26

    Capillary end caps recalled over an inadequate quality system

    ASP Global is recalling 620,502 SAFE-T-FILL end caps for blood gas capillaries over an inadequate quality system with unvalidated manufacturing processes.

    Product
    SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2026·2025-11-26

    Plasma separator microtubes recalled over an inadequate quality system

    ASP Global is recalling 49,000 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.

    Product
    AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0173-2026·2025-11-26

    Petrolatum barrier ointment recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 381,619 units of PeriGuard Ointment because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0170-2026·2025-11-26

    Lanolin skin protectant recalled over contamination found at the manufacturing site

    DermaRite Industries is recalling 57,837 units of Lantiseptic skin protectant because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0534-2026·2025-11-26

    Measles antibody tests recalled for being distributed without premarket clearance

    Quest International is recalling ReQuest Measles IgG enzyme linked immunoassay kits because the in vitro diagnostic was distributed without premarket approval or clearance.

    Product
    Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0560-2026·2025-11-26

    Sodium heparin capillary tubes recalled over an inadequate quality system

    ASP Global is recalling 1,000 SAFE-T-FILL plastic blood gas capillary tubes, 115 microlitres with sodium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    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
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0559-2026·2025-11-26

    Untreated blood gas tubes recalled over an inadequate quality system

    ASP Global is recalling 77,500 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres untreated, over an inadequate quality system.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
    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 (Devices)·Z-0556-2026·2025-11-26

    Untreated hematocrit tubes recalled over an inadequate quality system

    ASP Global is recalling 209,000 SAFE-T-FILL microhematocrit capillary tubes, 50 microlitres untreated, over an inadequate quality system with unvalidated processes.

    Product
    SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0174-2026·2025-11-26

    Zinc oxide barrier cream recalled over contamination found at the facility

    DermaRite Industries is recalling 37,272 tubes of Renew PeriProtect because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2026·2025-11-26

    Antimicrobial foam soap recalled over contamination found at the manufacturing facility

    DermaRite Industries is recalling 15,267 cartridges of KleenFoam Antimicrobial Foam Soap because it was made at the same facility where other products were found contaminated.

    Product
    KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
    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 (Drugs)·D-0164-2026·2025-11-26

    Skin protectant ointment recalled over contamination found at its manufacturing facility

    DermaRite Industries is recalling 2,673 tubes of DermaMed Ointment because it was made at the same facility where other products and lots were found to be contaminated.

    Product
    DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0552-2026·2025-11-26

    Three hundred microlitre heparin tubes recalled over unvalidated manufacturing processes

    ASP Global is recalling 6,050 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0544-2026·2025-11-26

    Lithium heparin microtubes recalled over an inadequate quality system

    ASP Global is recalling 78,000 SAFE-T-FILL micro capillary blood collection tubes, 125 microlitres with lithium heparin, over an inadequate quality system.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0536-2026·2025-11-26

    Shoulder reamer 46mm recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 46mm, because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
    Category
    Medical Device
    Distribution
    1 state