The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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24801–24825 of 26084

  • 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
  • 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 (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 sug
    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-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-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-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-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
  • HighFDA (Devices)·Z-2308-2021·2021-08-25

    Hitachi L43K intraoperative probe recall: screw cover may detach during sterilization

    Hitachi Healthcare is recalling 120 Model L43K intraoperative probes because the screw cover at the probe tip may fall off after cleaning and sterilization. Facilities should inspect probes before and after sterilization and before and after each surgical use.

    Product
    Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2021·2021-08-25

    IV Catheters recalled due to potential sterilization failure

    229,320 DELTAVEN FASTFLASH IV catheters distributed in Florida and Minnesota are being recalled due to sterilization defects. The medical devices may not be sterile, posing contamination and infection risks to patients.

    Product
    DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2021·2021-08-25

    Gore Propaten Vascular Graft Pediatric Shunt Dimension Labeling Error Recall

    W L Gore & Associates is recalling Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling: grafts with 6mm inner diameter are labeled 5mm, and those with 5mm diameter are labeled 6mm.

    Product
    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2309-2021·2021-08-25

    Dual Balloon Angioplasty Catheter Recalled for Balloon Deflation Difficulty

    Ostial Corporation is recalling the FLASH Ostial System dual balloon angioplasty catheter due to a manufacturing issue that may prevent proper balloon deflation, potentially causing access site complications.

    Product
    FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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
  • 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-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 (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-2298-2021·2021-08-25

    DELTAVEN Y IV Catheters Recalled Over Potential Sterilization Defect

    Delta Med is recalling DELTAVEN Y IV Catheters in Florida and Minnesota due to potential sterilization defects. The devices may not be properly sterilized, posing infection risks to patients.

    Product
    DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2021·2021-08-25

    TheraSphere Administration Set may leak or loosen at catheter connection

    Boston Scientific is recalling TheraSphere Administration Sets due to potential leaks and loosening at the patient catheter connection. Approximately 4,200 sets were distributed worldwide.

    Product
    TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2321-2021·2021-08-25

    RUSCH Endotracheal Tubes Recalled for Potential Cuff Inflation Malfunction

    Teleflex Medical Europe is recalling RUSCH endotracheal tubes because the cuff can inflate without the pilot balloon showing proper inflation. This defect could prevent clinicians from verifying correct cuff function.

    Product
    RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2021·2021-08-25

    Cytocell DNA Diagnostic Probe Recalled for Unexpected Chromosomal Signals

    Cytocell Ltd. is recalling a DNA diagnostic probe that may produce unexpected signals at additional chromosomal locations during testing. The affected probe is an in vitro diagnostic reagent used in laboratory cytogenetic analysis.

    Product
    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
    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