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.

44201–44225 of 50511

  • HighFDA (Devices)·Z-0655-2013·2013-01-16

    Concentric Medical Recalls FlowGate Balloon Guide Catheters Due to Tip Collapse

    Concentric Medical is recalling 13 FlowGate Balloon Guide Catheters after reports of resistance and possible distal tip collapse during use.

    Product
    FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0873-2013·2013-01-16

    Pastry Food Products Recalls Trigel Pizza Turnovers for Undeclared Milk

    Pastry Food Products Inc. is recalling Trigel Empanadillas de Pizza due to undeclared milk. The product was distributed in Puerto Rico.

    Product
    &TRIGAL***Empanadillas de Pizza (Pizza turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR&
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0652-2013·2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network Inc. is recalling UltraFill DBM Putty-Porcine because the products may contain trace amounts of 316L Stainless Steel particulates.

    Product
    UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0644-2013·2013-01-16

    Applied Medical Recalls Kii Shielded Bladed Access Systems Due to Blade Exposure Risk

    Applied Medical is voluntarily recalling 72 units of Kii shielded bladed access systems because the blade may remain exposed after shield deployment.

    Product
    Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0876-2013·2013-01-16

    Lifevantage Recalls Protandim Dietary Supplement Due to Metal Fragments

    Lifevantage Corp is recalling Protandim dietary supplements because tablets may contain small metal fragments. The recall affects 247,896 bottles sold in the US, Japan, Australia, Mexico, and Canada.

    Product
    Protandim is packaged in a 90cc cylindrical blue bottle with a silver cap and contains thirty caplets per bottle. Label has a blue background with multi-colored print and pictorial stating in part: Lifevantage PROTANDIM *the Nrf2 Synergizer Dietary Supplement I 30…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0658-2013·2013-01-16

    Zoll AutoPulse Resuscitation System Recalled for Unexpected Compression Stops

    Zoll Circulation is recalling AutoPulse Model 100 systems because they may stop compressions unexpectedly during use.

    Product
    AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0653-2013·2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network, Inc. recalled UltraFill DBM Putty-Porcine because products may contain trace amounts of 316L Stainless Steel particulates.

    Product
    UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0662-2013·2013-01-16

    Maquet Cardiosave Intra-Aortic Balloon Pump Recall for Cord Failure Risk

    Maquet is recalling 29 Cardiosave Intra-Aortic Balloon Pumps because the coiled cord assembly may fail if mishandled.

    Product
    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0663-2013·2013-01-16

    Merit Medical Recalls Custom Procedural Trays Due to Particulate Matter

    Merit Medical Systems is recalling 422 Custom Procedural Trays and Kits because of particulate matter found in the 0.9% Sodium Chloride Injection.

    Product
    Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0660-2013·2013-01-16

    Biomet Recalls PT Hybrid Glenoid Post Due to Oversized Thread

    Biomet is recalling PT Hybrid Glenoid Posts because an oversized male thread may prevent the post from seating fully, potentially creating a gap in the implant.

    Product
    PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13092·2013-01-15

    Bugaboo Recalls Strollers Due to Fall and Choking Hazards

    Bugaboo is recalling Cameleon and Donkey strollers because a button on the carry handle can disengage, causing the handle to detach and posing fall and choking hazards to young children.

    Product
    Bugaboo Cameleon and Bugaboo Donkey Model Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13095·2013-01-15

    Target Recalls Circo Girls' Fleece Pajamas for Flammability Violation

    Target is recalling Circo girls' fleece pajamas because they fail to meet federal flammability standards, posing a risk of burn injuries to children.

    Product
    Girls' Circo Fleece Blanket Sleepers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V010000·2013-01-14

    GM Recalls 2013 Chevrolet Express and GMC Savana for Ignition Key Defect

    General Motors is recalling specific 2013 Chevrolet Express and GMC Savana vans because the ignition key can be removed while the vehicle is running or not in Park.

    Product
    CHEVROLET — CHEVROLET, GMC EXPRESS, SAVANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13090·2013-01-10

    A-Plus Marine Recalls Scuba Diving Air Hoses Due to Drowning Hazard

    A-Plus Marine is recalling high-pressure scuba diving air hoses because they can separate from the regulator, reducing air supply and posing a drowning hazard.

    Product
    High-pressure scuba diving air hoses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13718·2013-01-10

    BRP Recalls Can-Am Commander Side-By-Side Vehicles Due to Steering Hazard

    BRP is recalling about 3,400 Can-Am Commander side-by-side vehicles because improper steering assembly can cause loss of control, posing a risk of serious injury.

    Product
    Can-Am® Commander side-by-side off-road vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0856-2013·2013-01-09

    Cocoa~Latte Hot Drink Maker Recalled Due to Lead Leaching Risk

    Focus Products Group is recalling Cocoa~Latte Hot Drink Makers because a brass bushing may leach lead into beverages.

    Product
    Cocoa~Latte Hot Drink Maker; an electric hot drink mixer and dispenser with a 32 fl.oz. heating and mixing jar, twist and lock lid, "perfect temperature" feature, mixing paddle, and dripless faucet; Focus Electrics, LLC, West Bend, WI 53095
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0625-2013·2013-01-09

    Hospira Recalls Plum A+3 Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 28,599 Plum A+3 infusion pumps worldwide because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of IV medication.

    Product
    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-122-2013·2013-01-09

    New England Compounding Center Recalls Omnipaque Vials Due to Sterility Concerns

    New England Compounding Center is recalling Omnipaque vials nationwide because the company cannot ensure the product is sterile.

    Product
    Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0623-2013·2013-01-09

    B. Braun Recalls Infusomat Space Pump Pole Clamps Due to Breakage Risk

    B. Braun Medical is recalling 13,078 Infusomat Space Pump Pole Clamps because the locking grids may break.

    Product
    Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
    Category
    Medical Device
    Distribution
    Distributed nationwide