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.

11076–11100 of 22147

  • HighFDA (Devices)·Z-2148-2024·2024-06-26

    MONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect

    Ethicon recalls 306,000 MONOCRYL surgical sutures worldwide due to holes in primary packaging from a manufacturing defect that compromises sterility and could result in infection.

    Product
    MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2024·2024-06-26

    NxStage PureFlow-B Hemodialysis Solution Bags Recalled Due to Bursting Chambers and Caustic Fluid

    NxStage PureFlow-B hemodialysis solution bags may burst during preparation, releasing caustic electrolyte fluid that can cause chemical burns. Affected units are distributed nationwide.

    Product
    NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0557-2024·2024-06-26

    Little Remedies Gas Relief Drops Class II Recall for Manufacturing Deviations

    Denison Pharmaceuticals recalls 113,544 bottles of Little Remedies Gas Relief Drops (Lot #0855, exp. 8/31/2025) due to manufacturing deviations. All units have been recovered and controlled at the manufacturer.

    Product
    LITTLE REMEDIES — LITTLE REMEDIES (SIMTHICONE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-1385-2024·2024-06-26

    Milk Chocolate Confectionery Coating Recalled for Potential Salmonella

    Clasen Quality Chocolate Inc. is recalling Milk Chocolate Flavored Confectionery Coating Bulk (Item #60692) due to potential Salmonella contamination. The product was distributed across nine U.S. states.

    Product
    Milk Chocolate Flavored Confectionery Coating Bulk (MB), Item # 60692.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0555-2024·2024-06-26

    FDA Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity Specification Failure

    Eugia US LLC recalls 70,125 vials of Dexamethasone Sodium Phosphate injection due to failed impurity specifications. Testing found sulfonic acid adduct of dexamethasone phosphate exceeded allowed limits.

    Product
    DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1386-2024·2024-06-26

    Milk Chocolate Wafer recalled for potential Salmonella contamination

    Clasen Quality Chocolate Inc. is recalling Milk Chocolate Wafer (Item #51407) distributed in nine states due to potential Salmonella contamination.

    Product
    Milk Chocolate Wafer, Item # 51407 (R&D Sample).
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0558-2024·2024-06-26

    OSSOS-SANS tablets recalled: undeclared diclofenac and methocarbamol found

    OSSOS-SANS Reforzado tablets are being recalled because they contain undeclared active pharmaceutical ingredients—diclofenac and methocarbamol—and were marketed without FDA approval.

    Product
    OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1379-2024·2024-06-26

    Snow White Chocolate Bulk Product Recalled for Potential Salmonella

    Clasen Quality Chocolate Inc. is recalling Snow White Chocolate bulk tanker product due to potential Salmonella contamination. The product was distributed across multiple states.

    Product
    Snow White Chocolate, Item #: 60949. Bulk tanker.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2149-2024·2024-06-26

    Ethicon MONOCRYL Plus Sutures Recalled for Packaging Defect

    Ethicon recalled 287,892 MONOCRYL Plus Antibacterial Sutures worldwide due to a packaging machine defect that created holes in primary packaging, potentially compromising sterility and risking infection.

    Product
    MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1382-2024·2024-06-26

    Clasen Quality Chocolate White Confectionery Wafers Recalled for Salmonella

    Clasen Quality Chocolate is recalling NGMO White Confectionery Wafer due to potential Salmonella contamination. The product was distributed across nine states.

    Product
    NGMO White Confectionery Wafer, Item # 60975. Net Wt. 25 lbs (11.34kg). Clasen Quality Chocolate 5126 West Terrace Drive, Madison, WI 53718
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2150-2024·2024-06-26

    TabloCart power cord connector may overheat in hemodialysis system

    Outset Medical is recalling 431 TabloCart hemodialysis system carts due to power cord connector defects that may cause overheating, sparks, and smoke, potentially delaying treatment or causing burns.

    Product
    TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1376-2024·2024-06-26

    Moore Family Farms Cheddar Cheese Curds recalled for E. coli contamination

    Moore Family Farms and Creamery Cheddar Cheese Curds are being recalled due to high coliform and E. coli levels. The recalled product was distributed in Iowa.

    Product
    Moore Family Farms and Creamery Cheddar Cheese Curds, 1 pound plastic bags, packaged with white ties
    Category
    Food
    Distribution
    1 state
  • HighCPSC·24281·2024-06-25

    MGA Entertainment Recalls Miniverse Make It Mini Sets with Liquid Resins

    MGA Entertainment recalls about 21 million Miniverse Make It Mini Sets with unused liquid resins due to risk of skin, eye, and respiratory irritation. The recalled sets contain acrylates in amounts prohibited in children's products.

    Product
    Miniverse Make It Mini Sets with Liquid Resins
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24277·2024-06-20

    Head Rush Technologies Recalls TRUBLUE iQ Auto Belay Devices for Fall Hazard

    Head Rush Technologies is recalling TRUBLUE iQ Auto Belay Devices because they can fail to retract, creating a risk of serious injury or death from falls. About 2,200 units were sold online from November 2022 through February 2024.

    Product
    TRUBLUE iQ Auto Belay Devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24275·2024-06-20

    Babboe Cargo Bicycles Recalled for Frame Cracking and Fall Hazard

    Babboe cargo bicycles manufactured by Babboe B.V. are being recalled because their frames can crack, bend, and break, posing a fall hazard to riders. The recall affects about 300 units sold in the United States through bicycle retailers nationwide between January 2011 and March 2024.

    Product
    Cargo bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24269·2024-06-20

    StyleCraft Instinct Cordless Hair Clippers Recalled for Fire and Burn Hazards

    StyleCraft is recalling about 50,000 Instinct Professional Vector Motor Cordless Hair Clippers because the lithium-ion battery can overheat, posing fire and burn hazards. Six incidents of battery overheating or fire have been reported, including one minor burn.

    Product
    Instinct Professional Vector Motor Cordless Hair Clippers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24278·2024-06-20

    Orly Lavender Scented Candles Recalled for Fire and Burn Hazards

    CBOCS Distribution Inc. is recalling about 3,600 lavender scented candles in wooden bread bowls sold at Cracker Barrel Old Country Store from November 2023 through May 2024. The candle flames can reach excessive heights and ignite the wooden bowl, posing fire and burn risks.

    Product
    Lavender scented candles in a round wooden bread bowl
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24270·2024-06-20

    Yeti Link Expansion Modules and EC8 Cables Recalled for Fire and Burn Hazards

    Goal Zero is recalling about 34,460 Yeti Link Expansion Modules and EC8 Cables because the connections can overheat and melt, posing fire and burn hazards. Two reports of cables melting inside vehicles have been received with minor property damage but no injuries.

    Product
    Yeti Link Expansion Modules and EC8 Cables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24276·2024-06-20

    Vitamix Blending Containers and Blade Bases Recalled for Laceration Hazard

    Vitamix Ascent and Venturist Series 8-ounce and 20-ounce blending containers and blade bases can separate from their bases, exposing sharp blades. The company has received 27 reports of lacerations, including 11 from a previous 2018 recall.

    Product
    Vitamix Ascent® Series and Venturist® Series 8-ounce and 20-ounce Blending Containers and Blade Bases
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24274·2024-06-20

    Theefun Kids Gardening Tools Sets Recalled for Excess Phthalates

    Theefun Kids Gardening Tools Sets (model HJL-001) are recalled because the brown handle strings contain phthalates that exceed federal safety limits. Phthalates are toxic if ingested by young children.

    Product
    Theefun Kids Gardening Tools Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24279·2024-06-20

    Cedona Natural View Six-Drawer Dressers Recalled for Tip-Over Hazard

    Global Homes USA is recalling about 400 Cedona Natural View six-drawer dressers sold at Rooms To Go for tip-over and entrapment hazards that can injure or kill children if not anchored to a wall.

    Product
    Cedona Natural View six-drawer dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2024·2024-06-19

    Stimuplex A Anesthesia Needles Recalled for Undisclosed DEHP in Glue

    B Braun Medical Inc is recalling 108,811 units of Stimuplex A anesthesia needles because the devices are labeled as DEHP-free but the glue contains traces of DEHP.

    Product
    Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2041-2024·2024-06-19

    MRI Systems Power Cable Terminal Block Fire Hazard Recall

    Canon Medical MRI systems are being recalled because the terminal block securing the power cable may disconnect, potentially causing electrical arcing and fire. 153 units are affected across the United States and Puerto Rico.

    Product
    MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-2141-2024·2024-06-19

    Fresenius AquaA hemodialysis water purification device pressure control malfunction

    Fresenius is recalling 4 hemodialysis water purification devices for pressure control malfunctions. When concentrate pressure exceeds the 19.9 bar limit, the device stops supplying water and halts dialysis treatment.

    Product
    US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
    Category
    Medical Device
    Distribution
    Distributed nationwide