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.

651–675 of 52881

  • HighFDA (Devices)·Z-2322-2026·2026-06-17

    TDC VELOCE 23 gauge vitrectomy cutters may have loose outer knife

    TDC VELOCE 23G Two Dimensional Cutters are being recalled following an increase in complaints of a loose outer knife, including reports of it loosening during use.

    Product
    TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2026·2026-06-17

    CGuard Prime 9mm by 30mm carotid stents may fail deployment

    CGuard Prime Carotid Stent Systems, 135 cm with a 9 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.

    Product
    CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2026·2026-06-17

    Boston Scientific Clik X anchors may lack sterility assurance

    Boston Scientific Clik X Anchors, model SC-4318, are being recalled because the sterile anchors may lack sterility assurance. 43 units are affected.

    Product
    Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2407-2026·2026-06-17

    Halyard pain packs shipped without validated sterilization in Iowa

    Halyard Pain Packs, kit code AMPK48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 120 kits affected.

    Product
    Halyard, Pain Pack. Kit Code: AMPK48-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2333-2026·2026-06-17

    CORFLO Safety PEG kit 30-4320 contains recalled lidocaine injection

    CORFLO Safety PEG Kits, catalog number 30-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 231 kits are affected.

    Product
    Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2026·2026-06-17

    MIC Safety 14 Fr PEG kits contain recalled lidocaine injection

    MIC Safety PEG Kits with ENFit Connectors, 14 Fr PULL, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall for quality issues.

    Product
    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2026·2026-06-17

    CORFLO Safety PEG kit 50-5320 contains recalled lidocaine injection

    CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-5320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 72 kits affected.

    Product
    Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2026·2026-06-17

    MIC Safety 24 Fr push OTW PEG kits contain recalled lidocaine

    MIC Safety PEG Kits with ENFit Connectors, 24 Fr PUSH OTW, catalog number 8170-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall.

    Product
    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2026·2026-06-17

    Abbott Merlin pacemaker programmer may fail to terminate threshold test

    Merlin Patient Care System programmer software is being recalled because a malfunction during a pacing capture threshold test may stop the command to terminate the test being communicated.

    Product
    Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2026·2026-06-17

    Aluminum chloride hemostatic gel kits shipped with wrong package insert

    Advance Aluminum Chloride Gel Clear Hemostatic Gel Kits are being recalled because some units contain the package insert for Ferric Sulfate Gel, which gives different first aid instructions.

    Product
    Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0940-2026·2026-06-17

    Park St. Deli macaroni and cheese does not declare soy

    Park St. Deli Macaroni & Cheese, 20 oz, is being recalled because of undeclared soy lecithin. The action covers 58,405 cases.

    Product
    Park St. Deli Macaroni & Cheese, NET WT 20 OZ (1 LB 4 OZ) 567g, product packed in plastic tub and placed into paperboard sleeve. 9/20 oz packages per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2398-2026·2026-06-17

    Siemens Dimension tacrolimus reagent cartridges may bias results positively

    Three lots of the Siemens Dimension Tacrolimus Flex reagent cartridge are being recalled because of a potential positive bias in quality control and patient sample results.

    Product
    Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2335-2026·2026-06-17

    CORFLO Safety PEG kit 30-6312 contains recalled lidocaine injection

    CORFLO Safety PEG Kits, catalog number 30-6312, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 31 kits are affected.

    Product
    Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2026·2026-06-17

    MOSAIQ oncology software may fail to load adapted treatment plan

    The MOSAIQ Oncology Information System is being recalled because the software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2410-2026·2026-06-17

    Halyard eye bag packs shipped without validated sterilization in Iowa

    Halyard Eye Bag Packs, kit code UIEB48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 60 kits affected.

    Product
    Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2026·2026-06-17

    CORFLO Safety PEG kit 50-6316 contains recalled lidocaine injection

    CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-6316, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 54 kits affected.

    Product
    Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2330-2026·2026-06-17

    CGuard Prime 10mm by 40mm carotid stents may fail deployment

    CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.

    Product
    CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2026·2026-06-17

    GE Allia IGS Pulse systems pose shock risk to service personnel

    Allia IGS Pulse angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on.

    Product
    Allia IGS Pulse angiographic X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2026·2026-06-17

    CGuard Prime 8mm by 30mm carotid stents may fail deployment

    CGuard Prime Carotid Stent Systems, 135 cm with an 8 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.

    Product
    Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2345-2026·2026-06-17

    MIC Safety 20 Fr pull PEG kits contain recalled lidocaine injection

    MIC Safety PEG Kits, 20 Fr PULL, catalog number 7180-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 3,184 kits affected.

    Product
    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2342-2026·2026-06-17

    MIC Safety 20 Fr push PEG kits contain recalled lidocaine injection

    MIC Safety PEG Kits, 20 Fr PUSH OTW, catalog number 7170-20, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 901 kits affected.

    Product
    Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0607-2026·2026-06-17

    Budesonide inhalation ampules contain black and brown specks and particles

    Budesonide Inhalation Suspension, 1 mg/2 mL single-dose ampules from Sun Pharmaceutical, is being recalled after a quality complaint of black or brown specs and particles in the solution.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2026·2026-06-17

    EXENT Analyser marked plates as passed without performing quality control

    An EXENT Analyser is being recalled after plates 2 and 3 were marked as passed although quality control appeared not to have been performed, despite samples being measured.

    Product
    Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide