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.

11276–11300 of 22152

  • 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-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 (Devices)·Z-1898-2024·2024-06-05

    Radiographic imaging system tubes may fall due to bolt rupture

    FUJIFILM's FDR Visionary Suite radiographic imaging system has bolts that may rupture due to fatigue, potentially causing the tube support to fall and injure patients. The recall affects 18 units distributed across nine states.

    Product
    FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1271-2024·2024-06-05

    Mother's Day Heart Box Recalled for Undeclared Coconut Allergen

    Maribel's Sweets, Inc. is recalling its 7.7-piece Mother's Day heart box due to undeclared coconut. The product may pose a risk to consumers with coconut allergies. Approximately 4,011 boxes were distributed nationwide and through online retailers.

    Product
    7. 7pc Mother s Day heart box
    Category
    Food
    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-1904-2024·2024-06-05

    Trevo Pro Microcatheters Recalled for Potential Endotoxin Contamination

    Stryker Neurovascular is recalling Trevo Pro 14 and 18 Microchethers worldwide due to non-compliance with endotoxin testing standards. High endotoxin levels could cause fever, shock, and meningitis.

    Product
    Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2024·2024-06-05

    Ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling approximately 29,190 V-Lance ophthalmic surgical knives due to reports of blade sharpness defects. Affected instruments are distributed worldwide, including as components in Alcon Custom Pak surgical procedure packs.

    Product
    20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0515-2024·2024-06-05

    Moxifloxacin intraocular injection vials recalled for sterility assurance failure

    Imprimis NJOF, LLC recalls Moxifloxacin intraocular injection vials nationwide due to lack of sterility assurance. The 18,980 affected vials (lot 23OCT013) should not be used.

    Product
    Moxifloxacin 0.8 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 71384-509-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1893-2024·2024-06-05

    Captus 4000e Thyroid Uptake System recalled for unexpected collimator detachment

    Mirion Technologies is recalling 1,275 units of the Captus 4000e Thyroid Uptake System worldwide due to complaints of unexpected collimator detachment.

    Product
    Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1905-2024·2024-06-05

    Trevo NXT neurovascular devices recalled for inadequate endotoxin testing

    Stryker Neurovascular is recalling Trevo NXT neurovascular intervention devices because they did not receive adequate endotoxin testing during manufacturing. High endotoxin levels may cause fever, shock, or aseptic meningitis.

    Product
    Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2024·2024-06-05

    Mako Robotic Surgery Software Error May Delay Orthopedic Treatments

    Stryker Orthopaedics recalls Mako surgical system software versions that can produce error codes requiring system restart before switching between surgical applications, potentially causing 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.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0529-2024·2024-06-05

    Golden Tiger Pain Relief Cream Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to the active ingredient being out of specification and improper grade propylene glycol being used during manufacturing.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2024·2024-06-05

    BD Pyxis Anesthesia Station 4000 Recalled for Fluid Ingress Fire Risk

    CareFusion's BD Pyxis Anesthesia Station 4000 is recalled due to potential fluid ingress that may cause smoke, fire, or system downtime. The recall involves 11,875 units distributed worldwide.

    Product
    BD Pyxis(TM) Anesthesia Station 4000, REF: 338
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2024·2024-06-05

    ClearCut and A-OK ophthalmic surgical knives recalled for sharpness issues

    Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 427,764 units are affected worldwide.

    Product
    ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2024·2024-06-05

    BD Pyxis MedStation ES Medication Cabinet Fluid Ingress Fire Hazard

    BD Pyxis MedStation ES medication cabinets may experience fluid ingress, potentially causing smoke, fire, or system downtime. CareFusion is recalling 212,367 units globally.

    Product
    BD Pyxis MedStation ES, REF: 323, Medication Cabinet
    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-0521-2024·2024-06-05

    Pain Relieving Cream Recalled Due to Out-of-Specification Active Ingredient

    ARG Laboratories' Natural Pain Relieving Cream Golden Tiger is being recalled due to out-of-specification active ingredient and improper-grade propylene glycol used in manufacturing. No illnesses have been reported.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00005 5
    Category
    Drug
    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 (Drugs)·D-0530-2024·2024-06-05

    ALOE GATOR SPF 40+ Sunscreen Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories is recalling ALOE GATOR SPF 40+ sunscreen (4 oz, Lot 04023C1) distributed nationwide due to out-of-specification active ingredient levels that may affect product efficacy.

    Product
    ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1900-2024·2024-06-05

    EsophaCap Sponge May Detach From String During Removal

    Lucid Diagnostics is recalling EsophaCap medical devices (220 units in MN and MD) because the sponge may detach from the string during removal, particularly at esophageal sphincters.

    Product
    Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2024·2024-06-05

    Stryker Neurovascular Microcatheter Recall Due to Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling the Trevo Trak 21 Microcatheter due to potential endotoxin contamination from inadequate testing. High endotoxin levels may increase risk of fever, shock, and aseptic meningitis.

    Product
    Trevo Trak 21 Microcatheter, Catalog: 90338
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0526-2024·2024-06-05

    Golden Tiger Pain Relief Cream Recalled for Out-of-Specification Ingredients

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to an active ingredient that does not meet specifications and violative grade propylene glycol used during manufacturing.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8
    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-1928-2024·2024-06-05

    BD Pyxis MedStation 4000 Medication Cabinet Fire Risk Recall

    CareFusion 303, Inc. is recalling approximately 91,933 units of the BD Pyxis MedStation 4000 System medication cabinet worldwide due to potential fluid ingress that may cause smoke, fire, or system downtime.

    Product
    BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2024·2024-06-05

    Stryker Mako Surgical System Software Error Affects Knee and Hip Replacements

    Stryker Orthopaedics is recalling Mako surgical system software used for knee and hip replacement procedures due to a software error that causes treatment delays when switching between surgical applications without proper system restart.

    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.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
    Category
    Medical Device
    Distribution
    Distributed nationwide