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.

28801–28825 of 50488

  • HighFDA (Devices)·Z-1889-2018·2018-05-23

    Ethicon 5mm Endopath Xcel Trocar Recalled for Lubrication Defect

    Ethicon Endo-Surgery Inc is recalling 5mm Endopath Xcel trocars due to insufficient lubrication, which may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may cause staple line failure, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2018·2018-05-23

    Zimmer Biomet Recalls Persona Cemented Tibial Plate Due to Cracks

    Zimmer Biomet is recalling 842 Persona Cemented Tibial Plate units due to potential cracks in the raw material that could compromise product cleanliness.

    Product
    Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2018·2018-05-23

    Medtronic Endo GIA Stapler Recall Due to Missing Sled Component

    Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2018·2018-05-23

    Medtronic Endo GIA Universal Stapler Sleeves Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal stapler sleeves and bypass units because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 BYPASS AIWA CLINIC Item Number: PST04090 BYPASS AIWA CLINIC Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18E036000·2018-05-22

    Fuel Helmets Recalls Open Face Helmets for Impact Protection Failure

    Fuel Helmets is recalling specific Open Face helmets that may not adequately protect the wearer's head in an impact, increasing the risk of injury.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18162·2018-05-22

    Porsche Recalls Wooden Toy Cars Due to Choking Hazard

    Porsche is recalling My First Porsche wooden toy cars because wheels and axles can detach, posing a choking hazard to young children.

    Product
    My First Porsche - Wooden Cars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V334000·2018-05-21

    2019 Coachmen Recreational Trailers Recalled for Incorrect Tire Placard

    Forest River is recalling 2019 Coachmen Clipper and Viking trailers because the Federal Placard lists incorrect tire pressure, which could lead to underinflation and tire failure.

    Product
    COACHMEN — COACHMEN CLIPPER, VIKING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V330000·2018-05-17

    Thomas Built Buses Recalls Minotour Transit Buses for Wheelchair Lift Defect

    Daimler Trucks North America is recalling 2003-2006 Thomas Built Buses Minotour transit buses because a missing relay may allow the wheelchair lift to operate while the vehicle is moving, increasing injury risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V326000·2018-05-17

    Rebel West Powersports Recalls One 2018 Rebel R4 LSV for Missing Reflectors

    Rebel West Powersports is recalling one 2018 Rebel R4 LSV because it lacks required rear side reflex reflectors, which reduces visibility to other drivers.

    Product
    REBEL WEST POWERSPORTS — REBEL WEST POWERSPORTS REBEL R4 LSV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2018·2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration

    Cook Inc. is recalling 886 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1621-2018·2018-05-16

    Boston Scientific Recalls Capio RP Sutures Due to Breakage Risk

    Boston Scientific is recalling 2,567 units of Capio RP sutures because they may break or detach during surgery.

    Product
    Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0784-2018·2018-05-16

    Kroger Recalls Sprycel Tablets Due to Lack of Processing Controls

    Kroger Specialty Pharmacy is recalling Sprycel 100 mg tablets because of a lack of processing controls. The affected product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.

    Product
    Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply
    Category
    Drug
    Distribution
    5 states
  • HighFDA (Devices)·Z-1619-2018·2018-05-16

    Boston Scientific Recalls Capio Open Access Box 4 Sutures

    Boston Scientific is recalling 21,051 units of Capio Open Access Box 4 sutures due to a potential for the sutures to break or detach during use.

    Product
    Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1636-2018·2018-05-16

    Vygon Maximum Barrier Insertion Tray Recalled for Potential Sterility Compromise

    Vygon U.S.A. is recalling Maximum Barrier Insertion Trays because potential friction holes may affect the product's sterility.

    Product
    Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2018·2018-05-16

    Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues

    Zimmer Biomet is recalling specific lots of Gentle Threads Interference Screws because they were overexposed to ethylene oxide sterilization, which may compromise the sterile barrier.

    Product
    Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2018·2018-05-16

    Microline Surgical Recalls ReNew Dolphin Nose Disposable Dissector Tips

    Microline Surgical is recalling specific lots of ReNew Dolphin Nose Disposable Dissector Tips due to a potentially compromised sterile barrier.

    Product
    ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1781-2018·2018-05-16

    Ninepoint Medical Recalls NvisionVLE Low-Profile Optical Probes

    Ninepoint Medical is recalling 152 NvisionVLE Low-Profile Optical Probes because the distal tips may detach from the probe shaft during use.

    Product
    NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1389-2018·2018-05-16

    Bob's Red Mill Whole Wheat Bread Mix Recalled for Undeclared Wheat

    Bob's Red Mill is recalling 100% Whole Wheat Bread Mix because the label fails to declare wheat, a major allergen.

    Product
    Bob's Red Mill 100% Whole Wheat Bread Mix, Item 1674C194, packaged in flexible packaging bag, 4 bags to a cardboard case, each bag weighs 19 oz. The UPC is 0 39978 00667 7. The label on the FRONT side of a package is read in parts: "***Bob's Red Mill ***100% WHOLE WHEAT…
    Category
    Food
    Distribution
    9 states