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.

41901–41925 of 50511

  • HighFDA (Devices)·Z-0846-2014·2014-02-05

    Focus Diagnostics Recalls Simplexa Flu A/B & RSV Direct Assay Kits

    Focus Diagnostics is recalling 1,052 Simplexa Flu A/B & RSV Direct assay kits due to sporadic false positive RSV signals that may lead to incorrect diagnostic results.

    Product
    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2014·2014-02-05

    Synergetics Recalls Sterile Ophthalmic Tubing Sets Due to Seal Failure Risk

    Synergetics Inc. is recalling 12 units of sterile ophthalmic tubing sets because faulty seals could fail, potentially compromising sterility.

    Product
    Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 746 Codman Certas Programmable Valves because they may not operate properly. The devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2014·2014-02-05

    Synergetics Recalls 23ga Chow Illuminated Pick Due to Faulty Seals

    Synergetics Inc. is recalling 38 units of 23ga Chow Illuminated Picks due to faulty seals that could compromise sterility.

    Product
    23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0845-2014·2014-02-05

    Philips Healthcare Recalls InnerCool RTx Endovascular Systems Due to Temperature Reading Errors

    Philips Healthcare is recalling 50 InnerCool RTx Endovascular Systems because the main control board may display inaccurate low patient temperature readings and trigger false alarms.

    Product
    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 409 units of Codman Certas Programmable Valves because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1434-2014·2014-02-05

    Lambs Farm Raspberry Swirl Bread Recalled for Undeclared Soy Allergen

    The Lambs Farm, Inc. is recalling Raspberry Swirl Bread loaves sold in Bread Trio gift boxes because the labels do not declare soy allergens.

    Product
    Raspberry Swirl Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2014·2014-02-05

    Synergetics Recalls 25ga Awh Chandelier Ophthalmic Devices Due to Seal Failure

    Synergetics Inc is recalling 36 units of 25ga Awh Chandelier ophthalmic devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1464-2014·2014-02-05

    Walmart Great Value Tex Mex Trail Mix Recalled for Undeclared Milk

    Ann's House of Nuts, Inc. is recalling Walmart Great Value Tex Mex Trail Mix because it contains undeclared milk, a major food allergen.

    Product
    Walmart Great Value Tex Mex Trail Mix, Net Wt 28 oz (793g), Distributed by Wal Mart Stores, Inc., Bentonville, AR, packed in rigid clear plastic jars.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0828-2014·2014-02-05

    Accuray CyberKnife Robotic Radiosurgery System Recall for Mounting Assembly Issue

    Accuray is recalling 302 CyberKnife systems worldwide due to a potential safety issue where the Synchrony Boom Arm Mounting Assembly may detach.

    Product
    Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2014·2014-02-05

    Siemens Dimension Vista 500 and 1500 Systems Recalled for Flex Assignment Error

    Siemens is recalling Dimension Vista 500 and 1500 systems with software version 3.5.1 or lower because the system may assign the wrong Flex cartridge to user-defined methods.

    Product
    User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0844-2014·2014-02-05

    Carestream Recalls Kodak DirectView DR 7500 Dual Detector Systems

    Carestream Health is recalling 164 Kodak DirectView DR 7500 Dual Detector Systems due to a possible patient image display error.

    Product
    KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2014·2014-02-05

    Synergetics Recalls 27ga Endo Illuminator Due to Faulty Sterile Seals

    Synergetics Inc. is recalling 96 units of 27ga ONE-STEP Endo Illuminator devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2014·2014-02-05

    Synergetics Recalls 27ga Ophthalmic Chandelier Due to Faulty Sterile Seals

    Synergetics is recalling 24 units of 27ga ONE-STEP Awh/Tano Vivid Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2014·2014-02-05

    Synergetics Recalls 25ga Awh Vivid Chandelier Due to Faulty Seals

    Synergetics is recalling 108 units of 25ga Awh Vivid Chandeliers because faulty seals on the outer pouch could fail, potentially compromising the sterile status of the ophthalmic devices.

    Product
    25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2014·2014-02-05

    Synergetics Recalls 23ga Aspirating Endo Illuminator Due to Seal Failure

    Synergetics is recalling 43 units of 23ga Aspirating Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2014·2014-02-05

    ACUTE Innovations RibLoc U plus System Recalled for Malfunction Risk

    ACUTE Innovations is recalling 176 units of the RibLoc U plus system because the implants may malfunction during surgical installation.

    Product
    The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0826-2014·2014-02-05

    Navilyst Medical Recalls Port Kits Due to Sterilization Barrier Breach

    Navilyst Medical is recalling 920 Port Kits with Access Infusion Sets due to a possible breach of the sterilization barrier. The devices were distributed nationwide.

    Product
    Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2014·2014-02-05

    Spacelabs AriaTelemetry Transmitters Recalled for SpO2 Display Errors

    Spacelabs is recalling AriaTelemetry transmitters because they may display SpO2 values when sensors are disconnected or failed.

    Product
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2014·2014-02-05

    Synergetics Recalls Stiff 25ga Wide Field Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling specific lots of Stiff 25ga Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2014·2014-02-05

    Synergetics Recalls 23ga Endo Illuminator Due to Faulty Seals

    Synergetics Inc. is recalling 102 units of 23ga Endo Illuminator devices because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1432-2014·2014-02-05

    Lambs Farm Snowball Cookies Recalled for Undeclared Allergens

    The Lambs Farm, Inc. is recalling Snowball Cookies because the labels fail to declare milk, soy, and wheat allergens.

    Product
    Snowball Cookies sold under the Lambs Farm brand and packaged in a white metal tin with a net weight of 1 lb.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2014·2014-02-05

    Synergetics Recalls 72 Sterile Ophthalmic Endo Illuminators Due to Seal Failure

    Synergetics Inc. is recalling 72 sterile ophthalmic Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2014·2014-02-05

    Synergetics Recalls Stiff 25ga Chow Illuminated Pick Due to Seal Failure

    Synergetics Inc. is recalling 44 units of Stiff 25ga Chow Illuminated Picks because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide