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.

11301–11325 of 22152

  • HighNHTSA·23V358000·2024-06-05

    2021-2023 Ford Bronco Seat Belt Latch Accessibility Recall

    Ford is recalling certain 2021-2023 Bronco vehicles because first-row seat belt latch plates may be difficult to access, potentially preventing occupants from wearing their seat belts and increasing crash injury risk.

    Product
    FORD — 2022 FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V357000·2024-06-05

    Altec Aerial Devices Recalled for Water Intrusion Fire Risk

    Altec is recalling 2021-2023 aerial devices, digger derricks, and related equipment because water can leak into strobe lights, causing electrical short-circuits that increase fire risk. No injuries have been reported.

    Product
    ALTEC — 2021 ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1269-2024·2024-06-05

    9-Piece Signature Box Recalled for Undeclared Coconut

    Maribel's Sweets 9-piece signature boxes are recalled nationwide due to undeclared coconut. Consumers with coconut allergies should not consume this product.

    Product
    5. 9pc signature box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1899-2024·2024-06-05

    EsophaCap esophageal diagnostic sponge recalled for detachment risk

    Lucid Diagnostics recalls EsophaCap esophageal diagnostic sponges due to risk of sponge detachment from string during device removal. No injuries have been reported.

    Product
    Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1924-2024·2024-06-05

    Alcon ClearCut S and A-OK ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling about 19,867 ClearCut S and A-OK ophthalmic surgical knives worldwide due to an increase in complaints about blade sharpness.

    Product
    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-1909-2024·2024-06-05

    Synchro Guide Wires Recalled for Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling 2,859 Synchro guide wires in multiple configurations due to inadequate endotoxin testing during manufacturing. The devices may exceed acceptable endotoxin limits, increasing the risk of fever, shock, and aseptic meningitis.

    Product
    Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0510-2024·2024-06-05

    Zoledronic Acid Injection Recalled for Sterility Defect

    Dr. Reddy's Laboratories recalls Zoledronic Acid Injection 5mg/100mL due to lack of sterility assurance and leaking vials. Lot #G3000010 with 13,880 vials was distributed nationwide.

    Product
    ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2024·2024-06-05

    Mako Surgical Robot Software Error Causes Treatment Delay in Orthopedic Surgery

    Stryker Orthopaedics is recalling Mako surgical robot software due to an error that occurs when switching between surgical applications without restarting the system, resulting in treatment delays.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V387000·2024-06-05

    2021-2022 Escape Travel Trailers Recalled for Cracked LP Gas Fittings

    Escape Trailer is recalling 2021-2022 Escape travel trailers (models 17, 19, 21, and 5.0TA) due to cracked quick disconnect fittings in the LP gas system that may cause a gas leak and fire hazard.

    Product
    ESCAPE — 2021 ESCAPE ESCAPE 21
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2024·2024-06-05

    Tri-Staple 2.0 surgical stapler cartridge damage may cause incomplete stapling

    Covidien is recalling 1681 units of Tri-Staple 2.0 surgical staples due to potential cartridge damage that may result in poor staple formation and incomplete staple lines during surgery.

    Product
    Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0520-2024·2024-06-05

    Pain Wizard Topical Pain Relief Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories recalls Pain Wizard topical pain relief nationwide due to out-of-specification active ingredient and violative-grade propylene glycol used in manufacturing. No illnesses reported.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V351000·2024-06-05

    Fleetwood, Holiday Rambler Motorhomes Recalled for Damaged Trailer Hitch

    REV Recreation Group is recalling 2020-2024 Fleetwood Bounder, Holiday Rambler Vacationer, and select Fleetwood Southwind motorhomes. The trailer hitch may become damaged due to stress or overloading, potentially causing the towed vehicle to separate.

    Product
    FLEETWOOD — 2020 FLEETWOOD BOUNDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2024·2024-06-05

    Surgical screwdrivers recalled for failure to engage with implant screws

    Synthes surgical screwdrivers are being recalled because they lack a required relief cut and will not engage properly with 1.3mm and 1.5mm implant screws, potentially delaying surgery. The defect affects 261 units distributed in the US and Canada.

    Product
    STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0531-2024·2024-06-05

    EYLEA injectable eye medication recalled due to sterility and syringe breakage

    Regeneron is recalling 405,725 prefilled syringes of EYLEA (aflibercept) eye injection due to lack of assurance of sterility and complaints of syringe breakage. This FDA Class II recall affects multiple lots distributed nationwide.

    Product
    EYLEA — EYLEA (AFLIBERCEPT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0516-2024·2024-06-05

    Moxifloxacin Intraocular Injection Recalled for Sterility Assurance

    Imprimis NJOF, LLC is recalling specific lots of Moxifloxacin intraocular injections nationwide due to lack of assurance of sterility.

    Product
    Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0512-2024·2024-06-05

    Epinephrine-Lidocaine Intraocular Injection Vials Recalled for Sterility Assurance

    Imprimis NJOF, LLC is recalling 14,180 vials of Epinephrine-Lidocaine intraocular injection due to lack of assurance of sterility. These vials were distributed nationwide within the United States.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2024·2024-06-05

    Vercise Genus Deep Brain Stimulation Device May Reset During Charging

    Boston Scientific is recalling Vercise Genus Deep Brain Stimulation devices that may reset during system checks while charging. The reset causes temporary loss of stimulation and may lead to symptom worsening.

    Product
    Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V353000·2024-06-05

    Navistar International trucks recalled for inadequate back-up light visibility

    Navistar is recalling certain International trucks (2000-2024 model years) for inadequate back-up light visibility when reversing. Low visibility may not alert other drivers, increasing crash risk. Dealers will replace rear stop/turn signal lights free of charge.

    Product
    INTERNATIONAL — 2002 INTERNATIONAL 9100I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1902-2024·2024-06-05

    Trevo XP ProVue neurovascular retriever devices recalled for inadequate endotoxin testing

    Stryker Neurovascular's Trevo XP ProVue Retriever devices did not undergo adequate endotoxin testing and may exceed safe limits, potentially causing fever, shock, and aseptic meningitis.

    Product
    Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO14 2-PACK, Catalog: 80051 TREVO XP 4X20+PRO18 2-PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2024·2024-06-05

    BD Pyxis MedStation 4000 Auxiliary Tower: Potential Fluid Ingress Fire Risk

    The BD Pyxis MedStation 4000 Auxiliary Tower may allow fluid to enter the system, potentially causing smoke, system downtime, and fire. The FDA Class II recall affects 35,029 units distributed worldwide.

    Product
    BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2024·2024-06-05

    Centurion OB Instrument Tray Recalled for Detachable Needle Guide Component

    Medline is recalling Centurion OB Instrument Trays because the Trumpet Needle Guide ring can detach when excessive pressure is applied. This could affect instrument functionality during medical procedures.

    Product
    Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1896-2024·2024-06-05

    Philips Allura Xper FD10 system pivot brake failure after software update

    Philips is recalling Allura Xper FD10 medical imaging systems with software version 8.1.100 because the pivot brake may fail to engage, potentially causing unexpected table movements during procedures.

    Product
    Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0514-2024·2024-06-05

    Intraocular injection drug recalled due to sterility assurance failure

    Imprimis NJOF, LLC is recalling Dexamethasone-Moxifloxacin-Ketorolac intraocular injections (38,060 vials) due to lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V352000·2024-06-05

    Jeep Grand Cherokee Steering Column Intermediate Shaft Defect Recall

    Certain 2021–2023 Jeep Grand Cherokee models have an incorrectly assembled steering column intermediate shaft that may disconnect and cause loss of steering control, increasing crash risk. Chrysler is offering free inspection and replacement.

    Product
    JEEP — 2021 JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1266-2024·2024-06-05

    Ganache chocolate boxes recalled for undeclared coconut allergen

    Maribel's Sweets, Inc. is recalling 2pc signature Ganache boxes nationwide due to undeclared coconut allergen. Consumers with coconut allergies should not consume this product.

    Product
    2. 2pc signature Ganache box
    Category
    Food
    Distribution
    Distributed nationwide