The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

551–575 of 32242

  • SevereFDA (Devices)·Z-2678-2026·2026-07-22

    Abiomed Impella Introducer Kit Recalled Due to Potential Leakage

    Oscor Inc. is recalling Abiomed REF: 0052-3025 Introducer Kits for Impella heart pump due to potential leakage from the sidearm and hub region. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak under the sheath cap and along hub score lines.

    Product
    Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0689-2026·2026-07-22

    Cleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns

    Chiesi USA, Inc. is recalling Cleviprex (clevidipine) injectable emulsion due to lack of assurance of sterility. The affected product is distributed nationwide.

    Product
    CLEVIPREX — CLEVIPREX (CLEVIPIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2693-2026·2026-07-22

    ABIOMED Intro Kit Heart Pump Introducer Sheath Leakage Risk

    Abiomed, Inc. is recalling ABIOMED Intro Kit heart pump introducer sheaths due to potential leakage from under the sheath cap and along hub score lines. The manufacturing defects are not visually detectable by users.

    Product
    ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1158-2026·2026-07-22

    D'Dioses Coconut Ice Pop Recall Due to Undeclared Allergens

    D'Dioses Coconut Ice Pops (4 oz) may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. Consumers with allergies or sensitivities to these substances should not consume the product.

    Product
    Ice Pop, D'Dioses Coconut, 4 oz (85 g), with UPC 710594511867
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·H-1157-2026·2026-07-22

    WY Duck Sauce packets recalled due to potential metal fragments

    W.Y. Industries, Inc. is recalling WY Duck Sauce packets because the product may contain metal fragments. The recall affects 1,120 cases distributed to New York, New Jersey, Ohio, and Pennsylvania.

    Product
    WY Duck Sauce, 0.35 oz. (10 g), flexible film packets, 500 packets per case.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·H-1168-2026·2026-07-22

    D'Dioses Pina Colada Ice Pop Bar Recall for Undeclared Allergens

    D'Dioses Fruit Pops, Inc. is recalling D'Dioses Pina Colada ice pop bars because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40 dyes.

    Product
    Ice Pop, D'Dioses Pina Colada, 1 Bar (81.7 g), with UPC 710594511225
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·H-1169-2026·2026-07-22

    Ice Pop D'Dioses Limon recalled for undeclared allergens

    D'Dioses Fruit Pops, Inc. is recalling Ice Pop D'Dioses Limon 4 oz packages because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. Consumers with allergies or sensitivities to these ingredients should not consume the product.

    Product
    Ice Pop, D'Dioses Limon, 4 oz (85 g), with UPC 710594511836
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·H-1161-2026·2026-07-22

    Ice Pop D'Dioses Mamey Recalled for Undeclared Allergens

    D'Dioses Fruit Pops, Inc. is recalling D'Dioses Mamey Ice Pop (1 Bar, 81.7 g) because it may contain undeclared milk, pecans, pistachios, yellow #5, and red #40.

    Product
    Ice Pop, D'Dioses Mamey, 1 Bar (81.7 g), with UPC 827912008456
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2686-2026·2026-07-22

    ABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath

    Abiomed, Inc. is recalling ABIOMED Impella CP Introducer Kit 14 Fr units worldwide due to potential introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2682-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk

    Abiomed is recalling the Impella CP heart pump set (87,277 units worldwide) due to potential leakage from the introducer sheath that cannot be visually detected by users. The defect affects the 14Fr and 23Fr introducers included in every pump set.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1167-2026·2026-07-22

    D'Dioses Cookies Cream Ice Pops Recalled for Undeclared Allergens

    D'Dioses Cookies Cream Ice Pops may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. The product was distributed in NJ, CT, NY, and PA.

    Product
    Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 710594511362
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2680-2026·2026-07-22

    Abiomed Impella Introducer Kit recalled for potential fluid leakage

    Oscor Inc. is recalling the Abiomed Impella Hemostatic Peel Away Introducer System (23F) due to manufacturing defects that may cause leakage from the sidearm, under the sheath cap, or along the hub region.

    Product
    Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2683-2026·2026-07-22

    ABIOMED Impella CP Introducer Kit 14Fr heart pump safety recall

    ABIOMED Impella CP Introducer Kit 14Fr is being recalled due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.

    Product
    ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2707-2026·2026-07-22

    T-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure

    Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits containing Lidocaine HCL Injection USP 1% because the kits did not meet sterility release criteria.

    Product
    T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2691-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk

    ABIOMED Impella CP heart pump sets contain introducers that may leak from under the sheath cap and along hub score lines. These manufacturing defects are not visible during use.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2684-2026·2026-07-22

    ABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk

    Abiomed is recalling ABIOMED Introducer Kit 23 Fr due to potential sheath leakage from manufacturing defects. The leakage risk is not visually detectable and affects all current batches worldwide.

    Product
    ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1170-2026·2026-07-22

    D'Dioses Grocella Ice Pop Recalled for Undeclared Allergens

    D'Dioses Fruit Pops, Inc. is recalling D'Dioses Grocella Ice Pop (1 bar, 81.7 g) due to undeclared milk, pecans, pistachios, yellow #5, and red #40. The product was distributed in NJ, CT, NY, and PA.

    Product
    Ice Pop, D'Dioses Grocella, 1 Bar (81.7 g), with UPC 827912008531
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2689-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk

    ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1160-2026·2026-07-22

    Ice Pop D'Dioses Arroz con Leche Recalled for Undeclared Allergens

    D'Dioses Fruit Pops, Inc. is recalling D'Dioses Arroz con Leche Ice Pops because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40 that are not listed on the label.

    Product
    Ice Pop, D'Dioses Arroz con Leche, 4 oz (85 g), with UPC 710594511843
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2679-2026·2026-07-22

    Abiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk

    Oscor Inc. is recalling Abiomed introducer kits due to manufacturing issues that may cause the 14Fr and 23Fr introducer sheaths to leak. The recall affects approximately 1,332 units distributed in Massachusetts.

    Product
    Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2690-2026·2026-07-22

    Abiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage

    Abiomed is recalling the Impella CP Smart Assist Set due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. These manufacturing issues are not visually detectable.

    Product
    ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2708-2026·2026-07-22

    Arterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing

    Argon Medical Devices is recalling an Arterial Line Kit containing Lidocaine HCL Injection USP because the kits do not meet sterility release criteria, creating a risk of infection from non-sterile medical injection.

    Product
    Arterial Line Kit 20ga x 6, REF: 400115A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2704-2026·2026-07-22

    Transvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled

    Argon Medical Devices is recalling Transvenous Pacing Electrode Trays with Bipolar Balloon Pacing Electrode 5F because kits containing Lidocaine HCL Injection USP did not meet sterility release criteria.

    Product
    Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
    Category
    Medical Device
    Distribution
    Distributed nationwide