The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

1526–1550 of 52929

  • HighFDA (Devices)·Z-1710-2026·2026-04-08

    Medline bronchoscopy kits contain Olympus biopsy valves that shed fragments

    Medline is recalling six bronchoscopy and thoracic kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.

    Product
    Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRON
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1657-2026·2026-04-08

    Atellica hemoglobin A1c assay may return depressed patient results

    Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c because results may be depressed when the RCRP reagent is processed on the same analyzer, with bias increasing over time.

    Product
    Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0412-2026·2026-04-08

    Leader ultra lubricating eye drops recalled over sterility assurance failure

    Leader Ultra Lubricating Eye Drops, containing polyethylene glycol 400 and propylene glycol, are being recalled for lack of assurance of sterility.

    Product
    LEADER ULTRA LUBRICATING EYE DROPS — LEADER ULTRA LUBRICATING EYE DROPS (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2026·2026-04-08

    Monoject tuberculin syringe packages actually contain U-100 insulin syringes

    Cardinal Health is recalling two lots of Monoject Tuberculin Syringes because the packaging identifies them as 1 mL Luer Lock tuberculin syringes but the contents are U-100 insulin syringes.

    Product
    Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2026·2026-04-08

    Civco eTRAX 12G needle sensor may misreport needle tip position

    Civco is recalling the eTRAX Needle Sensor 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1748-2026·2026-04-08

    Paradigm insulin pump delivery varies with pump height changes

    Medtronic is recalling Paradigm insulin pumps models MMT-712 and MMT-715 because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    Paradigm Insulin Pump (MMT-712, MMT-715)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2026·2026-04-08

    Civco eTRAX 12G starter kit may misreport needle tip position

    Civco is recalling the eTRAX Needle System Starter Kit 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0421-2026·2026-04-08

    Prazosin hydrochloride further lots recalled over nitrosamine impurity levels

    A further quantity of Prazosin Hydrochloride tablets is being recalled after detection of the nitrosamine impurity N-nitroso-prazosin impurity C above acceptable limits.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1664-2026·2026-04-08

    Philips Allura Xper FD20 Biplane X-ray may not start reliably

    Philips is recalling the Allura Xper FD20 Biplane because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.

    Product
    ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1757-2026·2026-04-08

    Burlington Medical wrap aprons may lose radiation attenuation over time

    Burlington Medical is recalling wrap aprons made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.

    Product
    Burlington Medical, Wrap Aprons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0408-2026·2026-04-08

    Amneal tramadol tablets failed nitrosamine impurity specification at stability

    Amneal Pharmaceuticals is recalling two lots of Tramadol Hydrochloride Tablets 50 mg after a nitrosamine impurity was found out of specification at the 24-month stability interval.

    Product
    TRAMADOL HYDROCHLORIDE — TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2026·2026-04-08

    MiniMed 620G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 620G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 620G Insulin Pump (MMT-1750)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2026·2026-04-08

    Civco eTRAX 18G starter kit may misreport needle tip position

    Civco is recalling the eTRAX Needle System Starter Kit 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.

    Product
    eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1684-2026·2026-04-08

    CPX 4 tall height tissue expander infusion needles may be blunt

    Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth tall height range because the infusion sets may contain a dull or blunt needle tip.

    Product
    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2026·2026-04-08

    Burlington Medical blockers may lose radiation attenuation over time

    Burlington Medical is recalling blockers because of the potential for attenuation degradation over time, decreasing the lifespan of the product.

    Product
    Burlington Medical, Blockers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0415-2026·2026-04-08

    Rugby and Walgreens lubricant eye drops recalled over sterility assurance

    K.C. Pharmaceuticals is recalling Sterile Eye Drops Soothing Tears, sold as Rugby Lubricating Eye Drops and Walgreens Lubricant Eye Drops, for lack of assurance of sterility.

    Product
    STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1680-2026·2026-04-08

    Philips Azurion 5 M20 X-ray may not start from foot switch

    Philips is recalling the Azurion 5 M20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.

    Product
    Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0660-2026·2026-04-08

    Imu-Tek Colostrum-5 Capsules Recalled for Potential Under-Processing

    Imu-Tek Animal Health is recalling Imu-Tek Colostrum-5 120 Capsules (Lot #013, Expiration 092826) because the product is potentially under-processed. The product was distributed across 29 states.

    Product
    Imu-Tek Colostrum-5 120 Capsules; 30% IgG, 2 capsules 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band seal, 500 mg capsule, 7 38654 00026 7, Imu-Tek, Inc. Ft. Collins, CO 80524.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-1703-2026·2026-04-08

    VOLT bone taps swapped between lots carry the incorrect thread

    The 2.4 VOLT Tap Cortex Screw is being recalled after a full lot swap with the VOLT Locking Screw Tap left the bone taps with an incorrect thread.

    Product
    2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0413-2026·2026-04-08

    GoodSense original formula eye drops recalled over sterility assurance

    GoodSense Eye Drops Original Formula, containing tetrahydrozoline hydrochloride, are being recalled for lack of assurance of sterility.

    Product
    GOODSENSE EYE DROPS ORIGINAL FORMULA — GOODSENSE EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0409-2026·2026-04-08

    Quality Choice irritation relief eye drops recalled over sterility assurance

    Quality Choice Eye Drops Irritation Relief, containing tetrahydrozoline HCl and zinc sulfate, are being recalled for lack of assurance of sterility. 182,424 bottles are affected.

    Product
    QUALITY CHOICE EYE DROPS IRRITATION RELIEF — QUALITY CHOICE EYE DROPS IRRITATION RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1699-2026·2026-04-08

    da Vinci grasping retractor instruments recalled over broken grip cables

    Intuitive Surgical is recalling da Vinci S and Si Grasping Retractor Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

    Product
    Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp en
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1695-2026·2026-04-08

    Olympus SOLTIVE Pro laser power supply may fail producing smoke

    Olympus is recalling SOLTIVE Pro SuperPulsed Laser Systems because a potential defect in the 24V power supply module may render the system inoperable and produce smoke or a burning smell.

    Product
    Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2026·2026-04-08

    MiniMed 670G insulin pump delivery varies with pump height changes

    Medtronic is recalling MiniMed 670G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

    Product
    MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2026·2026-04-08

    Medline anterior hip pack contains recalled Olympus biopsy valves

    Medline is recalling the Anterior Hip Pack because it contains recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.

    Product
    MEDLINE ANTERIOR HIP PACK DYNJ64672B
    Category
    Medical Device
    Distribution
    Distributed nationwide