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.

41526–41550 of 50511

  • HighFDA (Devices)·Z-1271-2014·2014-04-02

    Mevion S250 Proton Radiation Therapy System Recalled for Positioning Error

    Mevion Medical Systems is recalling the S250 Proton Radiation Therapy System because a geometric positioning error can occur after rotational corrections are applied to treatment fields.

    Product
    MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2014·2014-04-02

    Teleflex Medical Recalls Polyglycolic Acid Sutures for Needle Attachment Defects

    Teleflex Medical is recalling 32,271 units of absorbable polyglycolic acid sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1282-2014·2014-04-02

    Teleflex Medical Recalls 12mm Weck Vista Cannula Due to Gas Leakage

    Teleflex Medical is recalling 12mm Weck Vista Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgical procedures.

    Product
    12mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports

    Teleflex Medical is recalling 55,521 Weck Vista Universal Balloon Open Access Ports due to gas leakage that may delay laparoscopic surgeries.

    Product
    5/10/12 Weck¿ Vista" Universal Balloon Open Access Port  Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2014·2014-04-02

    Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect

    Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.

    Product
    FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1688-2014·2014-04-02

    Plum Baby Food Recalled for Potential Choking Hazard from Plastic Spout Damage

    Plum Inc. is recalling specific varieties of Stage 2 World Baby food due to intermittent plastic spout damage that may cause choking.

    Product
    Stage 2 World Baby ; Zucchini & Spinach with Pasta Marinara; 3.5 oz. pouch. Product of USA distributed by Plum Inc., Emeryville, CA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1306-2014·2014-04-02

    Abbott i-STAT G3+ Cartridge Recall for Inaccurate Blood Gas Results

    Abbott Point of Care is recalling i-STAT G3+ Cartridges (Lot N13183) because they may produce incorrectly elevated PCO2 and depressed pH results.

    Product
    i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports

    Teleflex Medical is recalling 55,521 Weck Vista Universal Balloon Open Access Ports due to gas leakage that may delay laparoscopic surgeries.

    Product
    5/10/12 Weck¿ Vista" Universal Balloon Open Access Port  Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2014·2014-04-02

    Synthes Ulna Osteotomy System Drill Template and Saw Guide Recall

    Synthes, Inc. is recalling 343 Drill Templates and Saw Guides for the Ulna Osteotomy System due to potential mechanical failure of connecting screws or K-wires.

    Product
    Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2014·2014-04-02

    Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect

    Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.

    Product
    FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1690-2014·2014-04-02

    HP Hood Recalls my essentials Sour Cream Due to Metal Bolt Fragment

    HP Hood LLC is recalling my essentials brand sour cream because a metal bolt fragment from a filling machine was found in the product.

    Product
    my essentials brand sour cream, NET WT. 24 OZ. (680g), UPC 7 25439 10546 0 --- Firm on label: DISTRIBUTED BY DZA BRANDS, LLC 2110 Executive Drive, Salisbury, NC 28147 --- The sour cream is packed in a plastic container.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1684-2014·2014-04-02

    Fairway Grilling Sauce Recalled for Undeclared Fish Allergen

    Wolfgang B. Gourmet Foods is recalling Fairway brand Condiment Grilling Sauce because it contains undeclared fish (anchovies). The product was distributed in New York, New Jersey, and Connecticut.

    Product
    FAIRWAY brand CONDIMENT GRILLING SAUCE, NET WT 12 oz (340 g), UPC 7 58940 70609 3 -- Distributed By: Fairway Group Central Services LLC New York, New York 10027 --- The product is packaged in a glass bottle, 12 bottles per case.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1202-2014·2014-04-02

    Siemens Artis Q X-ray Systems Recalled for Potential Tube Breakdown

    Siemens is recalling 19 Artis Q and Artis Q biplane systems because a breakdown of the x-ray tube could result in loss of x-ray imaging during clinical operation.

    Product
    Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14C002000·2014-04-01

    Baby Trend Recalls 2011-2012 TrendZ Fastback Child Restraints for Buckle Defect

    Baby Trend is recalling 2011 and 2012 TrendZ Fastback 3-in-1 child restraints because the harness buckle may become stuck, making it difficult to remove a child in an emergency.

    Product
    CHILD SEAT:HARNESS/CROTCH BUCKLE recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V163000·2014-03-31

    Land Rover Recalls 2014 Range Rovers for Turn Signal Software Defect

    Jaguar Land Rover is recalling 5,238 2014 Range Rovers because a software defect may prevent the turn signal indicator from flashing at a double rate to warn of a malfunction.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V158000·2014-03-31

    Mercedes-Benz Recalls 2014 GL Models for Child Seat Anchor Defect

    Mercedes-Benz is recalling 2014 GL350, GL450, GL550, and GL63 vehicles because the second-row seat may not fold low enough for proper child seat anchoring.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GL550, GL450, GL350, AMG GL63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2014·2014-03-26

    Convatec Recalls Latex Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling Curion CuriStay Nelaton latex Foley catheters because the drainage lumen was found blocked by excess lubricious coating material.

    Product
    Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1215-2014·2014-03-26

    Biomet 3i Recalls BellaTek Zirconia Dental Abutments Due to Fracture Reports

    Biomet 3i is recalling BellaTek Zirconia Dental Abutments because of reports of fractures. The recall covers 10,454 units distributed worldwide.

    Product
    Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2014·2014-03-26

    Exactech Recalls Gibralt Spine System Polyaxial Screws Due to Material Error

    Exactech is recalling 242 Gibralt Spine System Polyaxial Screws because they contain springs made of type-304 stainless steel instead of the specified titanium alloy.

    Product
    Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and…
    Category
    Medical Device
    Distribution
    7 states