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.

23026–23050 of 50430

  • HighFDA (Food)·F-0967-2020·2020-06-03

    Wegmans Tuna and Provolone Sub Recalled for Metal Contamination

    Wegmans is recalling Tuna & Provolone Packaged Subs because they may contain pieces of metal. Consumers should not eat the product.

    Product
    Wegmans Tuna & Provolone Packaged Sub, Medium, 11 oz; UPC: 2-27031-00000; SELL BY 5/14-5/16
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2159-2020·2020-06-03

    Applied Medical Recalls Epix latis GRASPER Due to Tissue Damage Risk

    Applied Medical Resources Corp is recalling Epix latis GRASPER instruments because a protruding rivet may catch tissue and cause damage during use.

    Product
    Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-2132-2020·2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 200 units of Journey II Uni Resection Prep Trial instruments because a manufacturing defect could cause the device to disassemble during surgery.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2020·2020-06-03

    Biomet Recalls Knee Prosthesis Components Due to Endotoxin Concerns

    Biomet, Inc. is recalling 12 units of the Orthopedic Salvage System Tibial Bearing because of potential elevated endotoxin levels.

    Product
    Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0965-2020·2020-06-03

    Wegmans Tuna Salad Recalled for Potential Metal Contamination

    Wegmans Food Markets is recalling 958 units of Tuna Salad due to the potential presence of metal pieces.

    Product
    Wegmans Tuna Salad, 16 OZ (1 LB) 454 g; UPC: 77890-48147; SELL BY 5/21/20
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2100-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Joey Safety Screw Spike Sets

    Cardinal Health is recalling Kangaroo Joey Safety Screw Spike sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2133-2020·2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 195 reusable surgical instruments because a manufacturing defect could cause the device to disassemble during use.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2020·2020-06-03

    MOTek Medical Recalls Body Weight Support Light Due to Yoke Detachment Risk

    MOTek Medical is recalling 80 units of the Body Weight Support Light (Model RB011) because a manufacturing deviation may cause the yoke to detach from the cable guide.

    Product
    Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Joey Safety Screw Spike Sets

    Cardinal Health is recalling Kangaroo Joey Safety Screw Spike Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2149-2020·2020-06-03

    Biomet Recalls AGC Knee System Tibial Components Due to Endotoxin Levels

    Biomet, Inc. is recalling 54 units of AGC Knee System PS Molded Tibial Components because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2144-2020·2020-06-03

    Biomet Recalls Shoulder Implant Components Due to Endotoxin Levels

    Biomet is recalling 122 units of specific shoulder implant components due to potential endotoxin levels exceeding specifications.

    Product
    Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets

    Cardinal Health Inc. is recalling Kangaroo Epump Safety Screw Spike Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2152-2020·2020-06-03

    Biomet Recalls Vanguard Knee System Bearings Due to Endotoxin Levels

    Biomet, Inc. is recalling 107 units of Vanguard Knee System PS Mono Lock Tibial Bearings because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2020·2020-06-03

    Biomet Recalls Custom Knee Prosthesis Due to Potential Endotoxin Levels

    Biomet, Inc. is recalling a specific custom-made knee prosthesis due to the potential presence of elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2020·2020-06-03

    Abbott Recalls Architect iGentamicin Reagent Kits Due to Assay Interaction

    Abbott is recalling 6,087 Architect iGentamicin Reagent Kits because they may interact with troponin assays, potentially impacting patient results.

    Product
    ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2020·2020-06-03

    Greiner VACUETTE Blood Transfer Units Recalled for Needle Dislodgement Risk

    C.A. Greiner & Sohne Gesellschaftmbh is recalling VACUETTE Blood Transfer Units because needles may dislodge during use, posing a risk of needle stick injury or blood leakage.

    Product
    VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer blood from a syringe into the evacuated blood collection tube.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2151-2020·2020-06-03

    Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels

    Biomet, Inc. is recalling 11 units of Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specification limits.

    Product
    Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0979-2020·2020-06-03

    Johnson Sea Products Recalls Home Style Crab Cakes for Undeclared Allergens

    Johnson Sea Products is recalling Home Style Crab Cakes because the packaging fails to list wheat and soybean oil as ingredients.

    Product
    Home Style Crab Cakes in a plastic wrapped foam tray, 12 oz. (Four, 3 oz. crab cakes per package). 12 packages per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2109-2020·2020-06-03

    Argon Skater Introducer Set Recalled Due to Detaching Tungsten Coils

    Argon Medical Devices is recalling Skater Introducer Sets because tungsten coils on the guidewire may detach. The recall affects 15,795 units distributed in China and Taiwan.

    Product
    Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2163-2020·2020-06-03

    Hologic Panther Fusion Extraction Reagent-S Recalled for False Test Results

    Hologic is recalling Panther Fusion Extraction Reagent-S kits because a reagent component may cause false positive or negative flu test results, potentially delaying treatment.

    Product
    Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-0968-2020·2020-06-03

    Wegmans Tuna and Provolone Wheat Wrap Recalled for Metal Contamination

    Wegmans is recalling 958 units of Tuna & Provolone Wheat Wraps because they may contain pieces of metal. Consumers should not eat the product.

    Product
    Wegmans Packaged Tuna & Provolone Wheat Wrap, 9 oz; UPC: 2-27303-00000; SELL BY 5/14-5/16
    Category
    Food
    Distribution
    7 states