The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

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501–525 of 30597

  • SevereFDA (Devices)·Z-2200-2026·2026-05-20

    LVIS Intraluminal Support Device Stent Recalled Dimensional Nonconformance

    MICROVENTION INC. is recalling LVIS Intraluminal Support Devices due to dimensional nonconformance and incorrect device configuration that may result from manufacturing commingling, creating risk of vessel injury, thrombosis, or neurological events.

    Product
    LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0525-2026·2026-05-20

    Oasis Tears PF Lubricant Eye Drops Recalled for Sterility Assurance

    Oasis Medical, Inc. is recalling Oasis Tears PF preservative-free lubricant eye drops nationwide due to lack of assurance of sterility following FDA observations during an inspection.

    Product
    OASIS TEARS PF — OASIS TEARS PF (GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2140-2026·2026-05-20

    Namic Angiographic Manifold recalled for particulate contamination

    Medline Industries is recalling the Namic Angiographic Manifold (Product Number 64038402) because particulate matter has been found in the fluid path. This medical device is used in cardiopulmonary bypass procedures.

    Product
    Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2143-2026·2026-05-20

    Medline Medical Convenience Kits with Namic Manifold recalled

    Medline Industries is recalling medical convenience kits containing Namic Manifolds due to particulate matter found in the fluid path. The recall affects three kit models distributed nationwide and internationally.

    Product
    Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2145-2026·2026-05-20

    Medline Cardiac Catheterization Kits Recalled for Particulate Contamination

    Medline Industries is recalling multiple cardiac catheterization kits because particulate contamination has been found within the fluid path of the manifolds used in these kits.

    Product
    1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2139-2026·2026-05-20

    Namic Angiographic Manifold recalls due to particulate contamination

    Medline Industries is recalling Namic Angiographic Manifolds because particulate has been found in the fluid path of the devices. The affected units were distributed nationwide in the U.S. and internationally.

    Product
    Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2133-2026·2026-05-20

    On-X Mitral Heart Valve Model ONXMC-25/33 Released Without Complete Testing

    On-X Life Technologies is recalling the On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33, because the valves were distributed before all required testing was complete, preventing confirmation that they meet all release specifications.

    Product
    On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2167-2026·2026-05-20

    Hologic Selenia Dimensions Mammography Systems Loose Internal Bolts

    Hologic has recalled Selenia Dimensions Mammography Systems because internal bolts may become loose, missing, or broken over time. The company has received complaints of this issue affecting systems nationwide.

    Product
    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2141-2026·2026-05-20

    Namic Preceptor Manifold blood pressure transducers recalled for particulate contamination

    Medline Industries is recalling Namic Preceptor Manifold extravascular blood pressure transducers due to the presence of particulate matter within the fluid path. The recall affects 6,390 units distributed nationwide in the US and internationally.

    Product
    Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2147-2026·2026-05-20

    Medline medical convenience kits recalled for particulate contamination

    Medline Industries is recalling cardiac medical convenience kits containing Namic Manifolds due to the presence of particulate matter within the fluid path. The affected kits were distributed nationwide and internationally.

    Product
    Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2047-2026·2026-05-20

    Omnicell i.v.Station label stock rolls for syringe preparation

    Omnicell is recalling rolls of label stock used in the i.v.Station automation device due to potential for mislabeled syringes during IV medication preparation and compounding.

    Product
    Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automat
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2144-2026·2026-05-20

    Medline Cardiac Catheterization Kits Recalled for Particulate Contamination

    Medline Industries is recalling multiple cardiac catheterization kits due to the presence of particulate matter in the fluid path of manifolds. The affected kits were distributed nationwide and internationally.

    Product
    1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2026·2026-05-20

    Medtronic SynchroMed Flex Infusion Programmer Software Application

    Medtronic SynchroMed Flex Infusion Mode A810 Clinician Programmer Software may display infusion steps out of order, preventing medication from being delivered at the intended time. Affected devices are clinician programmer tablets worldwide.

    Product
    Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2163-2026·2026-05-20

    Dexcom G7 CGM iOS App Software Defect Delays Glucose Alerts

    Dexcom, Inc. is recalling versions 2.9.0 through 2.11.2 of the Dexcom G7 Continuous Glucose Monitoring iOS app due to a software defect that delays glucose value notifications and alerts, risking missed detection of dangerous blood sugar events.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recall Due to Incomplete Sterile Seals

    Stryker Sustainability Solutions is recalling 108 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The defect may compromise sterility assurance.

    Product
    Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic Deca Steerable reprocessed electrophysiology catheters (Product Number 201101) distributed nationwide and in Israel and Canada due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility.

    Product
    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2026·2026-05-20

    Daig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters (Product Number 401904) due to incomplete seals on sterile product. The recall affects 1,352 units distributed across the United States, Israel, and Canada.

    Product
    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2188-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Daig Livewire Steerable recalled

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product. The recall affects 19 units distributed nationwide in the US, Israel, and Canada.

    Product
    Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0779-2026·2026-05-20

    [pending] Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn; Ingredients: Non-GMO popcorn, br

    Pending LLM rewrite. Source: FDA_FOOD H-0779-2026.

    Product
    Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn; Ingredients: Non-GMO popcorn, brown sugar, corn syrup, butter, vanilla, baking soda, sea salt, white chocolate (sugar, palm kernel fat, skimmed milk powder [12%], emulsifier [lecithins], natural vanilla flavoring
    Category
    Food
    Distribution
    2 states