The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

1026–1050 of 32252

  • SevereFDA (Devices)·Z-1976-2026·2026-05-13

    Halyard NEURO IR PERIPHERAL kit syringe adapter may disconnect

    AVID Medical is recalling the Halyard NEURO IR PERIPHERAL (PS 64405) kit because the Medline syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1936-2026·2026-05-13

    Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands

    Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters because marker bands may crack or break, which could lead to device fragmentation, prolonged procedures, vessel injury, and in worst-case scenarios, life-threatening harm or death.

    Product
    Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0763-2026·2026-05-13

    Raw Farm jalapeno raw cheddar linked to multistate E. coli outbreak

    Raw Farm Raw Cheddar Jalapeno is being recalled in connection with a multi-state outbreak of E. coli O157:H7, covering the named batches and all prior batches and dates.

    Product
    RAW FARM RAW CHEDDAR Jalapeno NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt, 100% organic chili powder jalapeno, air dried green jalapeno peppers Produced By…
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1942-2026·2026-05-13

    VOCSN V+Pro Ventilator System Respiratory Device Safety Recall

    Ventec Life Systems is recalling VOCSN V+Pro ventilator units because they may not have been fully tested for high-pressure conditions, which could cause oxygen leaks and increase fire risk during use.

    Product
    VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Food)·H-0766-2026·2026-05-13

    Raw Farm bulk raw cheddar linked to multistate E. coli outbreak

    Raw Farm Original Raw Cheddar in 80 oz bulk format is being recalled in connection with a multi-state outbreak of E. coli O157:H7.

    Product
    RAW FARM ORIGINAL RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204001160
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·H-0837-2026·2026-05-13

    Bulk cheese sauce seasoning may be contaminated with Salmonella

    A bulk seasoning for cheese sauce is being recalled because the product has the potential to be contaminated with Salmonella. The action covers 24,012 lbs.

    Product
    Bulk WN-976-782-1 Seasoning for Cheese Sauce, Net Wt. 43.50 lbs., in a brown kraft bag
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1981-2026·2026-05-13

    Coronary angio packs recalled over Medline syringe rotating adaptor defect

    Coronary angio convenience kits are being recalled because they contain Medline Namic syringes whose rotating adaptor may unwind, risking disconnection from the manifold.

    Product
    Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1978-2026·2026-05-13

    Halyard SAMMC Angiography Kit syringe rotating adapter unwinding recall

    Halyard SAMMC ANGIOGRAPHY kits (Model SAMM066-15) are recalled because the Medline syringe rotating adapter may unwind during use, causing a loose or disconnected connection between the syringe and manifold. 2,392 kits were distributed across US states including FL, IL, MO, MS, NC, NE, and TX.

    Product
    Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1974-2026·2026-05-13

    Halyard CATH LAB Kit Due to Syringe Adapter Disconnection Risk

    AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75-01) due to risk that a Medline syringe rotating adaptor may unwind during use, causing loose or complete disconnection between the syringe and manifold.

    Product
    Halyard CATH LAB kit. Model Number: SACL75-01.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0519-2026·2026-05-13

    Octreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance

    Teva Pharmaceuticals USA, Inc. is recalling 2,200 kits of Octreotide Acetate for Injectable Suspension (30 mg) due to quality system deficiencies that affect sterility assurance. The recall affects all lots nationwide.

    Product
    OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0764-2026·2026-05-13

    Raw Farm shredded raw cheddar linked to multistate E. coli outbreak

    Raw Farm Raw Cheddar Simply Shredded Original in 8 oz packs is being recalled in connection with a multi-state outbreak of E. coli O157:H7.

    Product
    RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGERATED INGREDIENTS: WHOLE RAW MILK, VEGETABLE RENNET, CULTURES, KOSHER SEA SALT Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC…
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1979-2026·2026-05-13

    Halyard VA Detroit Cath Lab Pack Kit Syringe Adaptor Disconnection Risk

    Halyard VA Detroit Cath Lab Pack kits (Model VMCD029) are being recalled due to a potential risk that the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·H-0762-2026·2026-05-13

    Raw Farm original raw cheddar linked to multistate E. coli outbreak

    Raw Farm Raw Cheddar Original in 8 oz and 16 oz sizes is being recalled in connection with a multi-state outbreak of E. coli O157:H7.

    Product
    RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001177 16 oz…
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·H-0765-2026·2026-05-13

    Raw Farm bulk shredded cheddar linked to multistate E. coli outbreak

    Raw Farm Shredded Raw Cheddar in 80 oz bulk format is being recalled in connection with a multi-state outbreak of E. coli O157:H7.

    Product
    RAW FARM SHREDDED RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204000194
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-0518-2026·2026-05-13

    BD PurPrep Povidone-Iodine Topical Solution Sterility Assurance Recall

    CareFusion 213, LLC is recalling BD PurPrep (povidone-iodine 8.3% with isopropyl alcohol 72.5%) due to lack of assurance of sterility and potential product contamination. Affected lots are distributed nationwide.

    Product
    PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1975-2026·2026-05-13

    Halyard HEART CATH SELF REGIONAL kit syringe adapter disconnection hazard

    AVID Medical is recalling the Halyard HEART CATH SELF REGIONAL kit (Model SELF131-05) because the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1970-2026·2026-05-13

    Halyard Cardiac Cath Pack Kit Syringe Adapter Unwinding Risk

    AVID Medical recalls Halyard Cardiac Cath Pack kits (Models EAMC1000-05, WAFB208-02) due to risk that a Medline syringe rotating adapter may unwind during use, causing loose or full disconnection between the syringe and manifold.

    Product
    Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1973-2026·2026-05-13

    Halyard CATH LAB Kit Recalled for Syringe Adapter Disconnection Risk

    AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75AM) because the syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard CATH LAB kit. Model Number: SACL75AM.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1971-2026·2026-05-13

    Halyard CARDIAC CATH PACK SAN23CARDQ Kit Syringe Adapter Risk

    AVID Medical is recalling Halyard CARDIAC CATH PACK SAN23CARDQ kits (Model DRCC36) due to a Medline syringe rotating adapter that may unwind during use, potentially causing loose or full disconnection between the syringe and manifold.

    Product
    Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0513-2026·2026-05-13

    DELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues

    Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from bag perforations that could compromise sterility. Affected patients should contact their healthcare provider immediately.

    Product
    DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0540-2026·2026-05-13

    Lactated Ringers Injection Recalled for Particulate Matter Contamination

    B. Braun Medical Inc. is recalling Lactated Ringer's Injection USP (1000 mL containers) due to the presence of particulate matter. The recall affects 95,412 containers distributed nationwide.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2118-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterility assurance defects

    Medline Industries is recalling six models of medical device convenience kits due to calibration issues with sterilization and packaging equipment that may have reduced sterility assurance levels. The recall affects 553 units distributed nationwide.

    Product
    Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2097-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterilization issues

    Medline Industries is recalling multiple convenience kit models due to calibration issues with equipment used to sterilize and package the devices, which could affect sterility assurance levels.

    Product
    See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0524-2026·2026-05-13

    TPN Bag Recalled for Missing Insulin Formulation Error

    Central Admixture Pharmacy Services is recalling a patient-specific TPN bag because it did not contain insulin as listed on the label. Patients relying on this product for the labeled insulin dosage may face serious health risks.

    Product
    TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·26V309000·2026-05-13

    Lucid Air rear-wheel drive inverters may fail and cut drive power

    Lucid is recalling certain 2024-2025 Air rear-wheel drive vehicles because the Gen 4 inverter may experience internal friction and become damaged, causing a loss of drive power.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide