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.

10001–10025 of 22145

  • HighFDA (Devices)·Z-3163-2024·2024-09-25

    Innovasis spinal fusion devices recalled for implant-inserter interface defect

    Innovasis is recalling TxHA PEEK and TxTiHA IBF intervertebral fusion devices due to interfacing issues between the implant and inserter that may prevent proper placement. The recall affects 568 devices distributed nationwide.

    Product
    TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3138-2024·2024-09-25

    Infusion Pump Alaris System PC Unit 8015 Recalled for Bent Connector

    CareFusion's Alaris System PC Unit Model 8015 infusion pumps are being recalled due to a bent female IUI connector affecting over 125,000 devices. The defect may prevent the device from operating properly or delay infusion or monitoring startup.

    Product
    Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3139-2024·2024-09-25

    Alaris PCA Pump Module May Have Defective IUI Connector

    CareFusion recalls approximately 10,460 Alaris PCA Module Model 8120 infusion pumps worldwide due to potentially bent female IUI connectors that may prevent proper device operation and delay treatment initiation.

    Product
    Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1808-2024·2024-09-25

    Bliss Tree Ragi Butter Murukku recalled for undeclared milk allergen

    Bliss Tree Ragi Butter Murukku 200g and 400g packages are recalled due to undeclared milk. Consumers with milk allergies should not consume these products and contact their retailer.

    Product
    Bliss Tree Ragi Butter Murukku 200g UPC:8906087451754. Packaged in a box, 13 boxes per case Bliss Tree Ragi Butter Murukku 400g UPC:8906087452829. Packaged in a pouch, 8 pouches per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3172-2024·2024-09-25

    Smith & Nephew K-Wire Surgical Device Recall for Packaging Error

    Smith & Nephew is recalling K-Wire surgical devices due to a packaging error that resulted in wrong-sized wires being distributed. Healthcare providers may have received incorrectly sized bone fixation fasteners affecting approximately 73 units.

    Product
    DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3185-2024·2024-09-25

    Acceava Respiratory Strep A test kits recalled for unlicensed distribution

    Cypress Medical Products recalls Acceava Respiratory Strep A diagnostic test kits nationwide due to a classification error that caused them to be shipped to customers without proper licensing.

    Product
    Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1810-2024·2024-09-25

    Bliss Tree Pakoda Recalled Due to Undeclared Milk Allergen

    Bliss Tree Millet Butter Ribbon Pakoda is recalled because it contains undeclared milk. The product was distributed to retailers and wholesalers in five states and nationwide online.

    Product
    Bliss Tree Millet Butter Ribbon Pakoda 200g UPC:8906087451624. Packaged in a box, 13 boxes per case. Bliss Tree Millet Butter Ribbon Pakoda 400g UPC:8906087452843. Packaged in pouches, 8 pouches per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2024·2024-09-25

    Medline Contro-Bulb Syringe Recalled for Potential Sterile Barrier Breach

    Medline is recalling 4,831 Contro-Bulb Syringes due to potential sterile barrier breach during transportation. The recall affects two lot numbers and applies nationwide.

    Product
    Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3151-2024·2024-09-25

    Boston Scientific VTC Nephrostomy Catheter Kit Recalled for Sterile Barrier Defect

    Boston Scientific is recalling VTC Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier of the device pouch, which may compromise device sterility.

    Product
    VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1811-2024·2024-09-25

    Moringa Butter Murukku Recalled for Undeclared Milk Allergen

    Bliss Tree Moringa Butter Murukku 400g is recalled because it contains undeclared milk, a common food allergen. Consumers with milk allergies should not consume this product.

    Product
    Bliss Tree Moringa Butter Murukku 400g UPC:8906087452836. Packaged in pouches, 8 pouches per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3144-2024·2024-09-25

    Anesthesia Extension Sets recalled due to potential Spin Lock connector leakage

    B. Braun Medical is recalling 19,050 AET36 Anesthesia Extension Sets due to potential product leakage from the Spin Lock Connector caused by excess solvent migration during manufacturing.

    Product
    AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3181-2024·2024-09-25

    HAWK Warming Grid recalled for incorrect expiration date

    Safeguard US Operating LLC is recalling the HAWK Warming Grid (Item 59-300) due to an incorrect expiration date. The affected units may not function safely if used beyond the actual expiration date.

    Product
    HAWK Warming Grid, Item Number: 59-300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1813-2024·2024-09-25

    Bliss Tree Millet Butter Recalled for Undeclared Milk Allergen

    Bliss Tree Millet Butter is being recalled because it contains undeclared milk, a common allergen. The product was distributed to wholesalers and retailers in five states and to online customers nationwide.

    Product
    Bliss Tree Millet Butter Karasev 200g UPC:8906087451686. Packaged in a box, 13 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3173-2024·2024-09-25

    Hemodialysis Bloodline Tubing Recall Over Incomplete Connector Insertion Risk

    B Braun is recalling SL BLOODLINE FOR FMC 2008 SERIES hemodialysis tubing nationwide due to incomplete connector insertion that may cause blood flow restrictions during treatment.

    Product
    SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3155-2024·2024-09-25

    Shoulder implant recalled due to excessive bacterial endotoxin

    Tornier, Inc. is recalling one lot of the Stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS shoulder implant due to bacterial endotoxin exceeding safety specifications. The 5 affected units were distributed in Illinois, Wisconsin, Arizona, Nevada, and South Dakota.

    Product
    stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3164-2024·2024-09-25

    Endo Retrieval Pouches Recalled; Tube May Detach During Endoscopic Use

    Endo retrieval pouches are recalled because the tube may detach and fall into the surgical site during use. Approximately 81,241 units distributed in Georgia, Missouri, and Pennsylvania are affected.

    Product
    1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·24373·2024-09-19

    Place & Time Battery-Operated Desk Lamps Recalled Due to Fire Hazard

    Jo-Ann Stores recalls about 9,700 Place & Time battery-operated desk lamps due to fire hazard from overheating battery compartments during USB charging. No injuries reported, but three incidents of battery melting or popping have been documented.

    Product
    Place & Time battery-operated desk lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24366·2024-09-19

    Newmemo Children's Ring Sets Recalled for Lead and Cadmium Content

    Newmemo Children's Ring Sets sold on Amazon contain unsafe levels of lead and cadmium. These toxic metals can cause adverse health effects if ingested by young children.

    Product
    Newmemo Children's Ring Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24372·2024-09-19

    CVB Platform Beds with Upholstered Headboards Recalled for Fall and Injury Hazards

    About 137,000 Lucid platform beds with upholstered square tufted headboards can sag, break, or collapse during use. The manufacturer has received 245 reports of structural failure resulting in 18 reported injuries.

    Product
    Platform Beds with Upholstered Square Tufted Headboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24371·2024-09-19

    Caframo Cabinet Heaters Recalled for Electrocution Hazard

    Caframo Limited is recalling about 2,140 model 9421 cabinet heaters sold in the U.S. because a crimp holding a wire in place is not properly finished and can detach, creating an electrocution hazard.

    Product
    Cabinet Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24369·2024-09-19

    Polaris Sportsman ATVs Recalled for Fuel Leak Fire Hazard

    Polaris is recalling certain Model Year 2023–2024 Sportsman 850, XP 1000, and XP 1000 S ATVs because fuel can leak at the fuel pump outlet, creating a fire hazard. The company has received 14 reports of fuel leaks and 3 reports of fire, with no injuries reported.

    Product
    Model Year 2023-2024 Polaris Sportsman 850, XP 1000, and XP 1000 S ATVs and fuel pump kits and fuel tank assemblies
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24374·2024-09-19

    Polaris Model Year 2024 RANGER XD 1500 ROVs Recalled for Fire Hazard

    Polaris is recalling Model Year 2024 RANGER XD 1500 and Crew XD 1500 recreational off-road vehicles equipped with winches because the winch wiring can overheat during use, creating a fire hazard and risk of serious injury.

    Product
    Model Year 2024 RANGER XD 1500 and Crew XD 1500 Recreational Off-Road Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3041-2024·2024-09-18

    Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage

    Medline Industries is recalling medical convenience kits containing plastic syringes with leaks, breakage, and other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3027-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues. The affected devices have been distributed worldwide and may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 5) PORT TRAY , Pack Nu
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2992-2024·2024-09-18

    Medline Medical Convenience Kits with Defective Syringes Recalled

    Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by an FDA Safety Alert. These defects may pose risks to patient safety during medical procedures.

    Product
    Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number
    Category
    Medical Device
    Distribution
    0 states