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.

35951–35975 of 50504

  • HighFDA (Devices)·Z-1550-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling specific TC-Plus knee prostheses distributed in Germany and Switzerland because a dimensional deviation may prevent the polyethylene insert from seating correctly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1546-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling 15 units of TC-PLUS Primary Fixed Tibial Components due to a dimensional deviation that may prevent proper seating of the polyethylene insert.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0831-2016·2016-04-27

    Hospira Recalls Mannitol I.V. Bags Due to Chemical Contamination Risk

    Hospira Inc. is recalling 22,292 bags of Mannitol I.V. 20% due to potential contamination with an aromatic hydrocarbon resin.

    Product
    Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1507-2016·2016-04-27

    Stryker Recalls VariAx Compression Plating System Due to Screw Failure

    Stryker Howmedica Osteonics Corp. is recalling 118 units of the VariAx Compression Plating System because bone screws may pass through oblong holes during insertion.

    Product
    VariAx Compression Plating System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1089-2016·2016-04-27

    Bimbo Bakeries Recalls Fit & Active Multigrain Bread for Glass Contamination

    BIMBO Bakeries USA Inc. is recalling 2,080 bags of Fit & Active Multigrain Bread due to possible glass contamination. The product was distributed across ten southeastern and mid-Atlantic states.

    Product
    Fit & Active Multigrain Bread, 20 oz, On bag: AUG 31, UPC: 4149821093
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1506-2016·2016-04-27

    Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

    Philips Medical Systems is recalling 33 units of AutoSPECT Pro software because it may incorrectly reconstruct cardiac SPECT data acquired at non-standard detector angles.

    Product
    IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1500-2016·2016-04-27

    Siemens ADVIA 560 Hematology System Software Recall

    Siemens is recalling ADVIA 560 Hematology Systems because a software defect prevents the system from flagging immature granulocytes and atypical lymphocytes in patient samples.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-1081-2016·2016-04-27

    Starbucks Cheese and Fruit Bistro Box Recalled for Undeclared Cashews

    Flying Foods LLC is recalling Starbucks Cheese & Fruit Bistro Boxes because they may contain undeclared cashews. The product was distributed in Florida, Texas, and Oklahoma.

    Product
    Starbuck's Cheese & Fruit Bistro Box NET WT 5.3 OZ/150g packaged in non-flexible plastic container.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1518-2016·2016-04-27

    Siemens SOMATOM Definition CT Systems Recalled for Software Bugs

    Siemens Medical Solutions USA is recalling 1,096 SOMATOM Definition CT systems due to software bugs that may cause scan aborts, re-scans, or accidental radiation.

    Product
    Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2016·2016-04-27

    Ossur Lil Angel Vest Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling Lil Angel Vest P2 Lambswool units because the plastic stabilizer strap may partially or completely fracture.

    Product
    Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2016·2016-04-27

    Ossur Lil Angel Vest P2 Kodel Recalled for Potential Plastic Strap Fracture

    Ossur H / F is recalling 435 Lil Angel Vest P2 Kodel units due to a potential for partial or complete fracture of the plastic stabilizer strap.

    Product
    Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1087-2016·2016-04-27

    Sara Lee Multi-Grain Bread Recalled for Possible Glass Contamination

    BIMBO Bakeries USA Inc. is recalling specific Sara Lee Delightful Healthy Multi-Grain Bread products due to possible glass contamination.

    Product
    Sara Lee Delightful Healthy Multi-Grain Bread Twin pack, 2 lbs 8 oz, On bag: AUG 29, UPC: 7294561169; Sara Lee Delightful Healthy Multi-Grain Bread, 20 oz, On bag: SEP 01, UPC: 7294571588
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1505-2016·2016-04-27

    Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

    Philips Medical Systems is recalling the AutoSPECT Pro software application because it may incorrectly reconstruct cardiac SPECT data acquired with non-standard detector angles.

    Product
    Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1538-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components

    Smith & Nephew is recalling six units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1008-2016·2016-04-27

    True Nature Original Hummus Recalled for Undeclared Soy

    True Nature LLC is recalling Original Hummus 9oz containers due to undeclared soy from the ingredient Tamari. The recall affects 464 units sold in Oregon and Washington.

    Product
    Original Hummus 9oz container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1519-2016·2016-04-27

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bugs

    Siemens is recalling 1,096 SOMATOM Definition AS CT systems due to software bugs that may cause scan aborts, rescans, or accidental radiation.

    Product
    Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling specific TC-PLUS knee prostheses because a dimensional deviation may prevent surgeons from seating the polyethylene insert during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1504-2016·2016-04-27

    Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

    Philips Medical Systems is recalling the AutoSPECT Pro software application because it may produce erroneous results when processing cardiac SPECT data acquired at detector angles other than 90 or 180 degrees.

    Product
    Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-1083-2016·2016-04-27

    Hill Country Fare Chunk Light Tuna Recalled for Underprocessing

    HEB is recalling 5,376 cans of Hill Country Fare Chunk Light Tuna in Texas because the product may have been underprocessed.

    Product
    Hill Country Fare Chunk Light Tuna in pure vegetable oil NET WT. 5 OZ (142g) packaged in a metal can.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1084-2016·2016-04-27

    Specialty Commodities Recalls Dry Roasted Almonds Due to Undeclared Cashews

    Specialty Commodities, Inc. is recalling dry roasted almonds because cashews were mixed with the product but the cashew allergen was not declared on the packaging.

    Product
    Almonds, dry roasted, not salted, packaged in 25 lb. cardboard cartons
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1539-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components

    Smith & Nephew is recalling three TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1502-2016·2016-04-27

    Spacelabs Xhibit Telemetry Receiver Recall for Signal Loss

    Spacelabs Healthcare is recalling Xhibit Telemetry Receivers due to frequent signal loss that may cause offline errors on central monitors.

    Product
    The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1548-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Components

    Smith & Nephew is recalling 33 units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper assembly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states