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.

19476–19500 of 50410

  • HighFDA (Devices)·Z-2320-2021·2021-08-25

    RUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response

    Teleflex Medical Europe Ltd is recalling RUSCH Flexi-Set Cuffed Endotracheal Tubes nationwide because the cuff can inflate while the pilot balloon remains flat, preventing proper verification of cuff status.

    Product
    RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2021·2021-08-25

    CIRCUL8 LUXE DVT Prevention Device Marketed Without FDA Clearance

    The CIRCUL8 LUXE DVT Prevention Device is being recalled because it was marketed without FDA clearance. The device is intended to aid in the prevention of deep vein thrombosis.

    Product
    CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21189·2021-08-25

    Razor USA Recalls Hovertrax 2.0 Hoverboards with GLW Battery Packs for Fire Hazard

    Razor USA is recalling about 237,300 Hovertrax 2.0 self-balancing hoverboards with GLW lithium-ion battery packs that can overheat and catch fire or explode. More than 20 reports of overheating, smoke, or fire have been received, though no injuries have been reported.

    Product
    Hovertrax 2.0 Self-Balancing Scooters/Hoverboards with GLW Battery Packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2021·2021-08-25

    Trilogy Evo Ventilator Software Defect May Cause Pressure Increase

    Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.

    Product
    Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2021·2021-08-25

    FDA Recalls DELTAVEN Safety I.V. Catheters Due to Sterilization Defect

    Delta Med SpA recalls 30,900 DELTAVEN Safety I.V. Catheters in Florida and Minnesota due to potential sterilization failures that could compromise device sterility.

    Product
    DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2021·2021-08-25

    CT system software error recommends excessive contrast volume

    A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.

    Product
    728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2314-2021·2021-08-25

    Brilliance iCT Computed Tomography Systems Recalled for Contrast Dosing Error

    Philips Brilliance iCT CT systems with SynchRight P3T software may recommend incorrect contrast volume when patient weight is entered in pounds, potentially affecting patient safety.

    Product
    728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2021·2021-08-25

    Trilogy Evo Respiratory Device Recalled for Software Pressure Issues

    Philips Respironics has recalled Trilogy Evo Universal respiratory devices (model DS2000X11B) for software defects that increase pressure, particularly in pediatric and infant applications.

    Product
    Trilogy Evo Universal, Product number DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2021·2021-08-25

    I.V. Catheter Recall Due to Possible Sterilization Failure

    Delta Med recalls NEO DELTA SELFSAFE PUR T I.V. catheters distributed in Florida and Minnesota due to sterilization problems. Non-sterile catheters pose infection risks.

    Product
    NEO DELTA SELFSAFE PUR T, I.V. Catheter:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2021·2021-08-25

    Trilogy Evo O2 Ventilator Software Issues Affecting Pressure Delivery

    Philips Respironics is recalling Trilogy Evo O2 ventilators with software issues that can increase pressure delivery. One issue affects infant/pediatric settings; another causes pressure drift during continuous use.

    Product
    Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2021·2021-08-25

    Tornier Aequalis Pyrocarbon shoulder implants recalled for potential graphite exposure

    Tornier recalls Aequalis Pyrocarbon shoulder implants (6,631 units) due to potential patient exposure to graphite substrate material. The units were distributed across multiple U.S. states.

    Product
    The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog…
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2296-2021·2021-08-25

    FDA Recalls DELTAVEN Y Safety IV Catheters Due to Sterilization Issues

    Delta Med SpA is recalling DELTAVEN Y DNL Safety IV Catheters with closed system due to sterilization problems. The recalled units may lack proper sterility and pose a risk to patients.

    Product
    DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0915-2021·2021-08-25

    HiPP German Stage 2 Infant Formula Lacks Required FDA Pre-Market Approval and Labeling

    Able Groupe Inc is recalling HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula because it was not submitted for required FDA pre-market notification and lacks mandatory English labeling statements.

    Product
    HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0867-2021·2021-08-25

    Moonwalk 70% Dark Chocolate Bar Recalled for Undeclared Milk

    Cocanu LLC is recalling Moonwalk 70% dark chocolate bars because milk is not declared on the label, even though lactose is present. The product may pose a risk to consumers with milk allergies.

    Product
    Moonwalk 70% dark chocolate bar. It is packaged in white shiny paper with blue print. Net Weight: 1.2 oz / 35gr. No UPC. The label is read in parts: "***Moonwalk ***a 70% dark chocolate bar ***chocolate, cacao nibs and pop rocks ***Contents: cacao beans, cacao butter, cane…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2315-2021·2021-08-25

    CT5000 X-ray System Contrast Dose Calculation Error Under Pounds Setting

    Philips CT5000 X-ray systems may incorrectly calculate contrast volume doses when patient weight units are set to pounds. The software error could recommend higher-than-intended contrast volumes.

    Product
    Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2303-2021·2021-08-25

    IV Catheters Recalled by FDA for Sterilization Defects

    Delta Med is recalling NEO DELTA SELFSAFE PUR T IV catheters due to possible sterilization failures. The recall affects 14,000 units distributed in Florida and Minnesota.

    Product
    NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2021·2021-08-25

    Evexia Luxe DVT Prevention Device Recalled for Marketing Without FDA Clearance

    Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device because it was marketed without required FDA clearance. The device is intended to prevent deep vein thrombosis.

    Product
    EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2021·2021-08-25

    Trilogy EV300 Ventilator Recalled for Software-Related Pressure Calibration Issues

    Philips Respironics is recalling the Trilogy EV300 ventilator due to software issues causing pressure calibration errors affecting infant and pediatric patients. The defects impact 18,936 units distributed in the United States.

    Product
    Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2322-2021·2021-08-25

    RUSCH Endotracheal Tube Cuff Inflation Malfunction Without Pilot Balloon Indication

    Teleflex recalls RUSCH endotracheal tubes because the cuff can be inflated while the pilot balloon remains flat, preventing proper monitoring of cuff pressure.

    Product
    RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2021·2021-08-25

    IV Catheters Recalled Due to Possible Missing Sterility

    Delta Med SpA is recalling NEO DELTA Self Safe 1 IV catheters due to possible missing sterility. The recall affects 5,000 units distributed in Florida and Minnesota.

    Product
    NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0868-2021·2021-08-25

    Vegetable Egg Rolls Recall: Undeclared Yellow #5 Dye

    T&R Enterprises USA, Inc. is recalling vegetable egg rolls because Yellow #5 dye is present in the product but not declared on the label. Consumers with allergies or sensitivities to Yellow #5 may be at risk.

    Product
    Vegetable egg rolls packaged either 96 3oz per case or 120 2oz per case, Manufacturer T&R Enterprises St. Louis MO.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2329-2021·2021-08-25

    Triathlon orthopaedic implant baseplate recalled for assembly defect

    Howmedica Osteonics is recalling the Triathlon Prim CEM baseplate (Lot JHS2H) due to a manufacturing defect that may prevent the insert from locking properly on the implant.

    Product
    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2313-2021·2021-08-25

    NEO-KATH Caudal Catheter Set Recalled Due to Stylet Protrusion Risk

    Epimed International is recalling the NEO-KATH Caudal Set (REF 201-2430) because the stylet may protrude from the catheter's tip, potentially causing tissue injury. The recall affects 140 units distributed in the US and internationally.

    Product
    NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2319-2021·2021-08-25

    RUSCH Slick Set Cuffed Endotracheal Tubes Recalled for Improper Cuff Inflation

    Teleflex Medical Europe Ltd. is recalling RUSCH Slick Set Cuffed Endotracheal Tubes because the cuff can inflate while the pilot balloon remains flat, potentially affecting airway pressure monitoring.

    Product
    RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2021·2021-08-25

    I.V. Catheter Recall Due to Sterilization Failures

    Delta Med is recalling approximately 1,400 NEO DELTA SELFSAFE PUR 1 I.V. catheters (Lot 00A1160806) distributed in Florida and Minnesota due to sterilization process defects that may result in non-sterile devices.

    Product
    NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
    Category
    Medical Device
    Distribution
    Distributed nationwide