The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

10276–10300 of 88183

  • HighFDA (Devices)·Z-0467-2025·2024-11-27

    Bard Marquee Biopsy Instruments Recalled for Potential Needle Detachment

    Bard Peripheral Vascular Inc. is recalling Bard Marquee Disposable Core Biopsy Instrument Kits due to a manufacturing defect where some units lack a needle retention feature, risking detachment during use and potential tissue damage or bleeding.

    Product
    Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0052-2025·2024-11-27

    FDA recalls Ramipril 2.5 mg capsules for manufacturing control deviations

    Lupin Pharmaceuticals is recalling Ramipril 2.5 mg capsules after sourcing the active ingredient from an unapproved vendor. Approximately 112,770 bottles were distributed to wholesalers nationwide.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect

    Abbott Medical is recalling the Navitor 29mm transcatheter aortic heart valve due to a manufacturing error affecting leaflet specifications. The defect could potentially impact long-term valve durability or cause valve failure.

    Product
    Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0142-2025·2024-11-27

    BELEVINI Dried Fruit Mix Recalled Due to Undeclared Sulfites

    BELEVINI dried fruit mix (apples, pears, plums) is being recalled because it contains undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.

    Product
    BELEVINI, DRIED FRUIT MIX (Apples, Pears & Plums w/pit), 500g, PLASTIC SOFT PACK, 6 PACKAGES PER CASE
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0488-2025·2024-11-27

    EnChroma Safety Glasses recalled for defective impact protection

    EnChroma Inc recalls 53 units of safety glasses with Rx indoor lenses that fail impact safety standards, posing a risk of eye injury. Affected models include Martinez Cx1 Indoor Rx, Summit Indoor Rx, and Martinez Black Cx Rx.

    Product
    EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0481-2025·2024-11-27

    CAIRE FreeStyle Comfort portable oxygen concentrator battery recharge failure

    Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators due to potential battery recharge failure. Affected units identified by serial number may not charge properly.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Valve Recalled for Manufacturing Defect

    Abbott is recalling Abbott Navitor Transcatheter Aortic Heart Valves (27 mm) due to a manufacturing error causing leaflet deflection values outside specifications. This could affect valve durability and potentially cause valve failure.

    Product
    Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0501-2025·2024-11-27

    OrganOx metra Liver Perfusion System Recalled for Battery Damage

    OrganOx Ltd is recalling 20 metra liver perfusion systems because battery movement caused a cell to short against the retention bracket.

    Product
    OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0141-2025·2024-11-27

    Great Value Cinnamon Rolls Recalled for Plastic Contamination Nationwide

    The JM Smucker Company is recalling Great Value Cinnamon Rolls nationwide due to possible plastic pieces in the product. Consumers should not consume affected units.

    Product
    Great Value Cinnamon Rolls 16.5oz UPC 078742201160, 12 retail units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2025·2024-11-27

    Posi-Stop Injection Needle Recalled Due to Manufacturing Debris Blockage

    Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Lot H11-23-057) because some units contain manufacturing debris that blocks the needle opening, preventing injection solutions from flowing properly.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2025·2024-11-27

    Acrobat-i Vacuum Stabilizer System Recalled for Sterile Barrier Compromise

    Maquet Cardiovascular is recalling approximately 33,823 units of the Acrobat-i Vacuum Stabilizer System due to manufacturing deviations that compromised the sterile barrier. Sterility cannot be assured for the 2-year shelf life.

    Product
    Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2025·2024-11-27

    Acrobat SUV Vacuum Stabilizer System Sterile Barrier Compromise Recall

    Maquet Cardiovascular is recalling the Acrobat SUV Vacuum Stabilizer System (Model C-OM-9000Z) due to manufacturing deviations that compromise the sterile barrier. Sterility cannot be assured during the 2-year shelf life, affecting approximately 10,778 units.

    Product
    Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2025·2024-11-27

    Abbott Navitor Heart Valve Recalled for Leaflet Deflection Manufacturing Defect

    Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve due to a manufacturing error in leaflet deflection that may affect valve durability and function.

    Product
    Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0506-2025·2024-11-27

    Z-800 Infusion System Recalled for Battery Depletion Risk

    Zyno Medical is recalling 34,994 units of the Z-800 Infusion System due to battery depletion risk from self-discharge and parasitic leakage current. The battery may not retain charge despite continuous AC power, potentially affecting device operation.

    Product
    Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0487-2025·2024-11-27

    Ethicon Recalls Monocryl Sutures Due to Component Mix-Up

    Ethicon, Inc. is recalling 16,524 units of Monocryl sutures because a manufacturing error may result in incorrect needle types, sizes, or suture lengths.

    Product
    MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0493-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect

    Three Abbott Navitor 29mm transcatheter aortic heart valves were recalled due to a manufacturing error that allowed valves with leaflet deflection outside specifications to be distributed. The defect could affect valve durability or cause valve failure.

    Product
    Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0145-2025·2024-11-27

    La Bonne Vie Camembert cheese recalled for potential Listeria contamination

    La Bonne Vie Camembert 8oz cheese (UPC 820581678616, BBD 12/24/2024) is being recalled due to potential Listeria monocytogenes contamination. Approximately 70 cases were distributed across 12 U.S. states.

    Product
    La Bonne Vie Camembert 8oz UPC 820581678616; 6 retail units per case
    Category
    Food
    Distribution
    12 states
  • HighFDA (Drugs)·D-0054-2025·2024-11-27

    Ramipril Capsule Medication Recalled Over Unapproved Vendor Manufacturing Deviations

    Lupin Pharmaceuticals is recalling 357,414 bottles of Ramipril 10 mg capsules due to CGMP deviations where the active pharmaceutical ingredient was sourced from an unapproved vendor. The affected product was distributed to 30 wholesalers with potential nationwide distribution.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2025·2024-11-27

    CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Charging Failure

    CAIRE FreeStyle Comfort portable oxygen concentrators may fail to recharge their batteries, potentially leaving patients without access to supplemental oxygen. Twenty-three units have been recalled.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2025·2024-11-27

    Posi-Stop Injection Needle Recall Due to Manufacturing Debris

    Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Catalog 4706) due to manufacturing debris in the inner sheath that can block the needle and prevent injection solution flow.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2025·2024-11-27

    Posi-Stop 25-Gauge Injection Needles Recalled for Manufacturing Debris Blockage

    Hobbs Medical is recalling Posi-Stop 25-Gauge injection needles because some units contain manufacturing debris that blocks the needle's inner diameter, preventing injection solutions from flowing properly.

    Product
    Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2025·2024-11-27

    Abbott Navitor Titan Heart Valve Recall: Manufacturing Defect

    Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.

    Product
    Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0061-2025·2024-11-27

    Lisinopril 10 mg Tablets Recalled for Metal Fragment Contamination

    Evaric Pharmaceuticals is recalling Lisinopril 10 mg tablets after a metal fragment was found embedded in a tablet. The affected lot (241103) was distributed nationwide; contact your pharmacist if you have this medication.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2025·2024-11-27

    JuggerLoc/ToggleLoc 2.9mm Drill Guide Warping in Packaging

    Biomet's JuggerLoc/ToggleLoc 2.9mm Drill Guide may warp when removed from packaging, potentially extending surgical time or causing tissue damage requiring intervention.

    Product
    JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
    Category
    Medical Device
    Distribution
    Distributed nationwide