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.

7576–7600 of 52964

  • HighFDA (Devices)·Z-2659-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled for Reduced Sharpness in Eye Surgery

    Alcon Research LLC is recalling 2,520 CLEARCUT HP2 DB ophthalmic knives due to increased reports of reduced sharpness. The affected lot 164RY1 was distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2582-2024·2024-08-28

    Spectrum Wireless Battery Modules fail to auto-document infusion status

    Spectrum Wireless Battery Modules may fail to send infusion status updates to hospital electronic medical records. The issue affects 17,377 units nationwide used with Spectrum V8 and IQ infusion pumps.

    Product
    Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2645-2024·2024-08-28

    ClearCut S Safety Sideport Knife Recalled for Decreased Sharpness

    Alcon Research LLC is recalling ClearCut S Safety Sideport Knife ophthalmic surgical instruments due to reports of decreased sharpness. Affected units may not perform as intended during eye surgery.

    Product
    Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2681-2024·2024-08-28

    Alinity hq Analyzer May Generate Incorrect Blood Test Results

    Abbott's Alinity hq Analyzer has been recalled due to software issues that can produce incorrect blood cell counts and hemoglobin measurements in certain circumstances. No illnesses have been reported.

    Product
    Alinity hq Analyzer, REF: 09P68-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2644-2024·2024-08-28

    Medical Device Recall: Ventana Anti-CD10 Antibody May Produce False Positive Results

    Ventana Medical Systems recalls its anti-CD10 (SP67) rabbit monoclonal antibody due to potential high background and off-target staining that could produce false positive test results. Approximately 22,839 kits distributed worldwide are affected.

    Product
    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2685-2024·2024-08-28

    Regard Kit Decanters Recalled for Defective Sterile Packaging

    ROi CPS LLC is recalling 78 Regard Kits containing Microtek decanters due to pin holes and tears in sterile packaging that cannot be identified visually. Defective packaging could compromise the sterile barrier.

    Product
    Regard Kit containing the Microtek decanter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2705-2024·2024-08-28

    Medline ENDO KIT procedure kits recalled for dimensional variation affecting fit

    Medline is recalling 2,588 ENDO KIT medical procedure kits worldwide due to dimensional variation that may cause difficulty fitting into the outer canister.

    Product
    Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled Due to Sharpness Defect

    Alcon is recalling 7,713 units of ClearCut and A-OK ophthalmic surgical knives due to reports of decreased sharpness. The defect may compromise surgical performance during eye procedures.

    Product
    Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2668-2024·2024-08-28

    Ophthalmic Knives Recalled for Sharpness Defects

    Alcon recalls A-OK ophthalmic knives for sharpness defects. Approximately 30,268 units distributed nationwide and internationally are affected.

    Product
    Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2665-2024·2024-08-28

    Ophthalmic knives recalled for insufficient sharpness in surgical instruments

    Alcon is recalling specific ophthalmic knives due to an increase in complaints regarding insufficient sharpness. Affected units may not perform as intended during surgical procedures.

    Product
    Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2024·2024-08-28

    Baxter Spectrum Wireless Battery Modules May Fail to Document Infusion Status

    Baxter Spectrum Wireless Battery Modules may fail to automatically transmit infusion status information to hospital electronic medical records systems. The software issue affects 17,377 units nationwide.

    Product
    Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2663-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled Due to Sharpness Defects

    Alcon is recalling ClearCut SB INTREPID 2.2 ANG ophthalmic surgical knives due to increased complaint reports about inadequate blade sharpness. The recall affects 35,199 units distributed across the United States and 41 other countries.

    Product
    Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2684-2024·2024-08-28

    VITROS XT Chemistry Slides Recalled for Dust Contamination of Diagnostic Results

    Ortho-Clinical Diagnostics is recalling 88,253 units of VITROS XT Chemistry ALB-TP Slides because they shed dust and debris during normal operation, potentially contaminating sodium test results and causing misdiagnosis.

    Product
    The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0639-2024·2024-08-28

    Rubbing Alcohol Recalled for Non-Sterile Water in Manufacturing

    ZEE Company's 70% isopropyl rubbing alcohol is being recalled because non-sterile water was used in production instead of sterile water, violating manufacturing standards. The product was distributed nationwide in the US and Canada.

    Product
    Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1746-2024·2024-08-28

    Great Value Apple Juice Recalled for Inorganic Arsenic Contamination

    Refresco Beverages is recalling Great Value 8oz apple juice in 6-packs due to inorganic arsenic levels above FDA guidance. The recall affects approximately 9,535 cases distributed across multiple U.S. states and Puerto Rico.

    Product
    Great Value; 8oz Apple Juice in 6 pack; 100% Juice; packaged in 8 oz. PET plastic bottles; UPC 0-78742-29655-5
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-2653-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled for Potential Sharpness Issues

    Alcon is recalling specific ophthalmic knives following an increase in complaint reports related to sharpness. These surgical instruments are used in eye procedures.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2706-2024·2024-08-28

    Medline procedure kit has dimensional variation affecting canister fitting

    Medline is recalling 3400 units of ENDO medical procedure kits due to a dimensional variation that may cause difficulty fitting the kit into its outer canister.

    Product
    Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness

    Alcon is recalling 4,481 units of ClearCut and A-OK brand ophthalmic surgical knives due to complaint reports of inadequate sharpness. These instruments are used in eye surgery and may not perform as intended.

    Product
    Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2024·2024-08-28

    Disposable 5 Lead Cable System May Contain Non-Approved ECG Leads

    Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.

    Product
    Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2688-2024·2024-08-28

    Barricaid Annular Closure Impactor recalled due to missing welds

    Intrinsic Therapeutics recalls 207 units of Barricaid Annular Closure Impactor devices nationwide due to manufacturing defects where at least two units are missing critical welds.

    Product
    Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2646-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled by Alcon Due to Sharpness Defects

    Alcon is recalling 3,721 units of its 25GA Valved Entry System ophthalmic knives due to complaint reports about sharpness. The devices were distributed nationwide and internationally to 50+ countries.

    Product
    Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2716-2024·2024-08-28

    Philips Allura Xper Interventional Fluoroscopy Systems Recalled for Incorrect Bolt

    Philips Allura Xper systems contain an incorrect half-threaded bolt in LTE kits instead of the required full-threaded bolt. Six units distributed worldwide have been affected.

    Product
    Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2703-2024·2024-08-28

    Medline medical procedure kits recalled for dimensional variation affecting canister fit

    Medline Industries recalled 6,998 medical procedure kits worldwide due to slight dimensional variations that may cause difficulty fitting into outer canisters. The Class II recall affects multiple procedure kit types distributed in the US and internationally.

    Product
    Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2677-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled Due to Sharpness Complaint Reports

    Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic surgical knives (Model 8065752438) due to increased complaint reports about sharpness.

    Product
    Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1743-2024·2024-08-28

    El Chilar Ground Cinnamon Recalled Due to Elevated Lead Levels

    EL Chilar-HF, LLC is recalling El Chilar Canela Molida (Ground Cinnamon) due to elevated lead levels detected in samples tested by the Maryland Department of Health. Affected products were distributed in Maryland.

    Product
    El Chilar, Canela Molida, Ground Cinnamon NET WT. 1.25 Oz (35g) , Spices Herbs, BOPP Bag, 12 units per cases
    Category
    Food
    Distribution
    1 state