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.

26776–26800 of 50462

  • HighFDA (Devices)·Z-0527-2019·2018-12-12

    Barco Front Cover Attachment Kit Recalled for Potential Falling Hazard

    Barco N.V. is recalling 2,087 MDRC-1119 Front Cover Attachment Kits because metal strips may deform, causing the protective cover to fall.

    Product
    Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2019·2018-12-12

    ASO Recalls Family Wellness Sterile Gauze Pads Due to Sterilization Concerns

    ASO, LLC is recalling Family Wellness First Aid Sterile Gauze Pads because they may not be fully sterilized. The affected units were distributed nationwide to ten states.

    Product
    Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2019·2018-12-12

    Capintec Recalls Captus 3000 Thyroid Uptake Systems Due to Spring Arm Failure

    Capintec Inc is recalling 385 Captus 3000 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.

    Product
    Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2019·2018-12-12

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling specific lots of M/DN Intramedullary Fixation Humeral Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19046·2018-12-12

    Stanley Commercial Hardware Locksets Recalled Due to Entrapment Risk

    dormakaba USA is recalling Stanley Commercial Hardware locksets because they may fail to open, posing an entrapment hazard in emergencies. No injuries have been reported.

    Product
    Door locksets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2019·2018-12-12

    Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling Pressure Sentinel Guide Wires because creases in the sealing area compromise product sterility. The recall affects 48,320 units distributed worldwide.

    Product
    Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0691-2019·2018-12-12

    First Source Chocolate and Nut Tray Recalled for Undeclared Nuts

    First Source, LLC is recalling Chocolate and Nut Trays because they contain undeclared pecans and cashews. The product was distributed in six states.

    Product
    Chocolate and Nut Tray. The product comes in a four-quadrant plastic tray, NET WT 37 OZ (2 LBS 5 OZ) 1.05KG, with UPC: 0 23637 43369 0.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0681-2019·2018-12-12

    Schnucks Crescent Rolls Recalled for Undeclared Milk Allergen

    English Bay Batter L.P. is recalling Schnucks BIG & FLAKY CRESCENT ROLLS due to undeclared milk in the ingredient list and contains statement.

    Product
    Schnucks BIG & FLAKY CRESCENT ROLLS, 6 ROLLS, NET WT 11.25 OZ UPC 0 41318 57046 5
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0537-2019·2018-12-12

    Zimmer Biomet Recalls Smooth Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling Smooth Guide Wires because creases in the sealing area may compromise product sterility. The recall affects 48,320 units distributed worldwide.

    Product
    Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2019·2018-12-12

    Philips Brilliance 10 Slice CT Scanner Recalled for Gantry Cover Failure Risk

    Philips is recalling Brilliance 10 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover and metal support to fail or fall.

    Product
    Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19047·2018-12-12

    White-Rodgers Recalls Emerson Sensi WiFi Thermostats Due to Fire Hazard

    White-Rodgers is recalling Emerson branded Sensi WiFi thermostats because contact between wires and household voltage can cause fire. No injuries have been reported.

    Product
    Emerson Branded Sensi WiFi thermostats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Concerns

    Zimmer Biomet is recalling 12,724 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2019·2018-12-12

    Philips Brilliance 6 Slice CT Scanner Recalled for Gantry Cover Separation Risk

    Philips Medical Systems is recalling Brilliance 6 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.

    Product
    Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V882000·2018-12-12

    Van Hool Recalls 2015-2018 Buses Due to Fire Extinguisher Defect

    Van Hool is recalling 2015-2018 TD925 and TDX25 buses because the fire suppression system actuator may fail to discharge during a fire.

    Product
    VAN HOOL — VAN HOOL TD925, TDX25
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2019·2018-12-12

    Stephanix D2RS Digital Dynamic Remote System Recalled for Table Movement Risk

    Stephanix is recalling 17 D2RS Digital Dynamic Remote Systems because the table may continue moving after a command is released.

    Product
    STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling Natural Nail System Tear Drop Guide Wires due to creases in the sealing area that compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2019·2018-12-12

    Philips Brilliance 16 Slice CT Scanner Recall for Cover Separation

    Philips is recalling Brilliance 16 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.

    Product
    Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2019·2018-12-12

    Philips Brilliance 64 CT Scanner Recall for Gantry Cover Separation Risk

    Philips Medical Systems is recalling Brilliance 64 CT scanners due to a potential fiberglass resin separation that could cause the gantry front cover to fail and fall.

    Product
    Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0683-2019·2018-12-12

    Smartypants Kids Complete Gummy Vitamins Recalled for Foreign Objects

    Smartypants Vitamins is recalling 60,726 bottles of Kids Complete gummy vitamins due to consumer complaints of finding foreign objects in the bottles.

    Product
    Smartypants Kids Complete, Non GMO Multi and omega 3's vitamin D3 for bones, vitamin B12 for Energy: 90 gummies. UPC 8 5136 00425 5 Distributed by SmartyPants Inc., Marina del Rey, CA 90292
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0553-2019·2018-12-12

    Zimmer Biomet Recalls 20mm Compress Device Short Anchor Plug

    Zimmer Biomet is recalling 6 units of the 20mm Compress Device Short Anchor Plug due to potential metal burrs that may prevent proper insertion of drill and transverse pins.

    Product
    Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18E113000·2018-12-11

    Gillig Recalls Fire Extinguishers Due to Actuator Malfunction

    Gillig LLC is recalling specific fire extinguishers sold as aftermarket parts because the actuator may fail to discharge the suppression agent, increasing injury risk during a fire.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide