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.

43626–43650 of 50511

  • HighFDA (Devices)·Z-1270-2013·2013-05-15

    Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise

    Baxter Healthcare is recalling specific lots of Non-DEHP Catheter Extension Set Kits because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2013·2013-05-15

    Siemens MicroScan MICroSTREP panels recalled for false susceptibility results

    Siemens is recalling MicroScan MICroSTREP plus Type 1 panels because they may produce false antimicrobial susceptibility results for Streptococcus agalactiae.

    Product
    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2013·2013-05-15

    Baxter Recalls Non-DEHP Y-Type Catheter Extension Sets Due to Sterility Compromise

    Baxter Healthcare is recalling 228,200 units of Non-DEHP Y-Type Catheter Extension Sets because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1379-2013·2013-05-15

    Maple View Farm Ice Cream Recalled for Undeclared Wheat and Soy Allergens

    Maple View Farm Ice Cream is recalling Cookie Dough flavor pints because they contain undeclared wheat and soy allergens.

    Product
    Maple View Farm Ice Cream, Cookie Dough, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1243-2013·2013-05-15

    Smiths Medical Recalls Embryo Replacement Catheters Due to Transfer Failure

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Two Stage Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2013·2013-05-15

    Smiths Medical Recalls Sure-Pro Ultra Embryo Replacement Catheters

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2013·2013-05-15

    Smiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters

    Smiths Medical ASD, Inc. is recalling 800 Wallace Sure-Pro Single Stage Embryo Replacement Catheters because the catheter cannot be passed through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2013·2013-05-15

    Synthes Radial Head Prosthesis Recalled Due to Potential Component Separation

    Synthes USA is recalling 417 trial radial head prostheses because the trial head may come loose from the implant stem during surgery. No adverse events have been reported.

    Product
    Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2013·2013-05-15

    Symmetry Medical Recalls Collins Radioparent Sternal Blades Due to Breakage Risk

    Symmetry Medical is recalling Collins Radioparent Sternal Blades because they may break during use. The recall covers 524 boxes distributed worldwide.

    Product
    Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor
    Category
    Medical Device
    Distribution
    11 states
  • HighCPSC·13191·2013-05-15

    Optimus Recalls Portable Electric Heaters Due to Fire Hazard

    Optimus is recalling about 355,000 portable electric heaters because they can ignite nearby combustible materials, posing a fire hazard. No injuries have been reported.

    Product
    Portable Infrared Radiant Quartz Electric Space Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2013·2013-05-15

    Smiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Two Stage Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2013·2013-05-15

    Smiths Medical Recalls Wallace Sure-Pro Ultra Embryo Catheters

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V198000·2013-05-15

    Gulf Stream Recalls 2013 RV Trailers Due to Awning Motor Defect

    Gulf Stream is recalling 2013 RV trailers because power awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing crash risk.

    Product
    GULF STREAM — GULF STREAM SEDONA, CANYON TRAIL, KINGSPORT, TRAIL MASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1277-2013·2013-05-15

    Olympus UES-40 Electrosurgical Unit Recalled for Overheating and Smoke

    Olympus America Inc. is recalling 608 UES-40 electrosurgical units due to overheating, smoke vapors, and operational failures.

    Product
    Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V200000·2013-05-15

    Blue Bird Recalls School Buses with Flip Seat Pinch Hazard

    Blue Bird is recalling 2010-2014 All American and Vision school buses equipped with specific C. E. White Flip Seats due to a risk of foot or toe pinch injuries.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2013·2013-05-15

    Cypress Medical Recalls MediChoice Umbilical Cord Clamps Due to Breakage

    Cypress Medical Products LLC is voluntarily recalling one lot of MediChoice Umbilical Cord Clamps because they are breaking upon use.

    Product
    Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1268-2013·2013-05-15

    Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise

    Baxter Healthcare is recalling specific lots of Non-DEHP catheter extension sets because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1378-2013·2013-05-15

    Maple View Farm Ice Cream Recalled for Undeclared Wheat and Soy

    Maple View Farm Ice Cream is recalling Cookies and Cream ice cream because it contains undeclared wheat and soy.

    Product
    Maple View Farm Ice Cream, Cookies and Cream, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·13V189000·2013-05-10

    Fleetwood Recalls 2013-2014 RVs Due to Power Awning Motor Defect

    Fleetwood RV is recalling 196 recreational vehicles because power awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing crash risk.

    Product
    FLEETWOOD — FLEETWOOD STORM, SEARCHER COMMERCIAL, PROVIDENCE, MONTARA COMMERCIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V193000·2013-05-10

    Altec Recalls 2010-2011 AC35/38 Cranes Due to Jib Bracket Defect

    Altec is recalling 2010-2011 AC35/38 cranes because the jib attachment bracket may fail under load, posing an injury risk to nearby people.

    Product
    ALTEC — ALTEC AC35/38 CRANE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13187·2013-05-09

    Toro Recalls Z Master Riding Mowers Due to Fire Hazard

    Toro is recalling specific 2012 and 2013 Z Master Commercial riding mowers because the idler pulley can rub against the fuel tank, posing a fire hazard.

    Product
    Toro® Z Master® Riding Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13185·2013-05-08

    Surly Pugsley Bicycle Forks Recalled Due to Fall Hazard

    Surly Bikes is recalling Pugsley bicycle forks that can bend above the disc brake mount, posing a fall hazard to riders.

    Product
    Surly Pugsley Bicycle Forks
    Category
    Consumer Product
    Distribution
    Distributed nationwide