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.

251–275 of 50462

  • HighFDA (Drugs)·D-0813-2026·2026-09-09

    Baxter Recalls CARDENE IV Nicardipine Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of CARDENE IV (Nicardipine Hydrochloride) injection due to CGMP deviations. The recall covers products distributed in the US, Puerto Rico, and Chile.

    Product
    CARDENE IV — CARDENE IV (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0811-2026·2026-09-09

    Baxter Recalls Vasopressin Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Vasopressin in 0.9% Sodium Chloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    VASOPRESSIN IN 0.9% SODIUM CHLORIDE — VASOPRESSIN IN 0.9% SODIUM CHLORIDE (VASOPRESSIN IN 0.9% SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3083-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alert notifications, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3064-2026·2026-09-09

    Johnson & Johnson Recalls HEALON Viscoelastic Products Due to Surgical Instructions

    Johnson & Johnson is recalling HEALON EndoCoat PRO and HEALON DUET PRO II viscoelastic products because surgical instructions may not adequately warn against forcing the cannula, which could cause eye injury.

    Product
    HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1306-2026·2026-09-09

    Prince Bakery Recalls Sesame French Bread for Undeclared Allergen

    Prince Bakery Inc is recalling 150 units of Prince Sesame French Bread in New York because sesame is not declared in the ingredient statement.

    Product
    Prince Sesame FRENCH BREAD; LONG FRENCH; Net Wt. 10 oz (284g); INGREDIENTS: ENRICHED BLEACHED FLOUR, (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-3055-2026·2026-09-09

    Medline Arterial Line Insertion Kits Recalled for Sterility Breach

    Medline is recalling 1,840 Arterial Line Insertion Kits due to potential packaging defects that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0818-2026·2026-09-09

    Baxter Recalls Clindamycin Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Clindamycin Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    CLINDAMYCIN PHOSPHATE — CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3042-2026·2026-09-09

    Philips CT Systems Recalled for Unintended Radiation Performance Issues

    Philips is recalling specific CT systems due to an unintended radiation issue that could affect equipment performance.

    Product
    Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3091-2026·2026-09-09

    Fresenius Recalls Granuflo Dry Acid Concentrate Due to Discoloration

    Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to complaints of blue-green discoloration in the product.

    Product
    GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3078-2026·2026-09-09

    Medline Recalls Cataract Preop Kits with Potentially Contaminated Applicators

    Medline is recalling specific lots of Cataract Preop Kits containing BD ChloraPrep Clear applicators due to potential packaging seal defects that could allow contamination.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3074-2026·2026-09-09

    Medline Convenience Kits Recalled Due to Potential Applicator Seal Defects

    Medline is recalling specific lots of convenience kits containing BD ChloraPrep applicators due to potential packaging seal defects that could allow contamination.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3081-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alerts, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3044-2026·2026-09-09

    AVID Medical Recalls Halyard Kits Due to Endotoxin Variability

    AVID Medical, Inc. is recalling 11,763 Halyard medical convenience kits due to potential unexpected variability in endotoxin levels.

    Product
    Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE PACK SNEDHCPDH, Model/Item Number (kit) DGSP71; 5) BASIC PACK DR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3054-2026·2026-09-09

    Medline Convenience Kits Recalled for Potential Sterility Breach

    Medline is recalling 434,595 convenience kits nationwide due to packaging defects that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010158C; 5) PEDI EMERGENCY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3067-2026·2026-09-09

    Medline Convenience Kits Recalled Due to Potential Applicator Seal Defects

    Medline is recalling specific lots of Convenience Kits containing BD ChloraPrep Clear applicators due to potential packaging seal defects that could lead to infection.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3050-2026·2026-09-09

    Medline Convenience Kits Recalled for Potential Sterility Breach

    Medline Industries is recalling 58,037 convenience kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4) DYNJ38145F, Catalog Number: DYNJ38145F; 5) DYNJ63199A, Catalog Number: DYNJ63199A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3077-2026·2026-09-09

    Medline Convenience Kits Recalled Due to Potential Packaging Seal Defects

    Medline is recalling specific lots of Convenience Kits containing BD ChloraPrep Clear applicators due to potential packaging seal defects that may allow contamination.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3070-2026·2026-09-09

    Medline Convenience Kits Recalled for Potential ChloraPrep Applicator Contamination

    Medline is recalling convenience kits containing BD ChloraPrep applicators due to potential packaging seal defects that could lead to infection.

    Product
    Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690 ACC010875 DRAWER 3 SYR/DRS/MON/NG 1 OF 3 ACC011073…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0806-2026·2026-09-09

    Baxter Recalls MYXREDLIN Insulin Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling MYXREDLIN insulin due to CGMP deviations. The recall covers specific lots distributed in the US, Puerto Rico, and Chile.

    Product
    MYXREDLIN — MYXREDLIN (INSULIN HUMAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3056-2026·2026-09-09

    Medline IV Start Kits Recalled for Potential Sterility Breach

    Medline is recalling 22,736 IV start kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Model Number: DYKM2187A; 5) IV BLOOD CULTURE KIT, Model Number: DYNDH1909A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3082-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alerts, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3088-2026·2026-09-09

    Medos Velys Robotic-Assist Station Recalled for Software Movement Issue

    Medos International Sarl is recalling 29 Velys Robotic-Assist Stations due to a software issue that may cause unintended robotic arm movement during surgery.

    Product
    Velys Enabling Tech Robotic-Assist Station REF: 451611001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3058-2026·2026-09-09

    Medline Pre-Op Kits Recalled for Potential Sterility Breach

    Medline is recalling 13,032 pre-operative kits nationwide due to packaging defects that may compromise sterility, posing a risk of microbial contamination.

    Product
    Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5) CATARACT PREOP KIT, Catalog Number: DYKS1583; 6) GENERAL PREOP KIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide