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.

37251–37275 of 50506

  • HighFDA (Food)·F-0145-2016·2015-11-11

    Krispy Kreme Chocolate Iced Glazed Doughnuts Recalled for Glass Contamination

    Krispy Kreme Doughnut Corporation is recalling Chocolate Iced Glazed Doughnuts because they may contain glass. Consumers should stop eating these products.

    Product
    Krispy Kreme Doughnuts, Chocolate Iced Glazed Doughnuts, 2 count, Net Wt. 3.5 oz., and Half Dozen, Net Wt. 12 oz., Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0138-2016·2015-11-11

    Krispy Kreme Chocolate Iced Doughnuts Recalled for Potential Glass Contamination

    Krispy Kreme Doughnut Corporation is recalling specific lots of Chocolate Iced Doughnuts with Kreme Filling because they may contain glass.

    Product
    Krispy Kreme Doughnuts, Chocolate Iced Doughnuts with Kreme Filling, 2 count, Net Wt. 4.65oz, and Half Dozen, Net Wt. 16.2 oz., Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0143-2016·2015-11-11

    Krispy Kreme Doughnuts Recalled for Potential Glass Contamination

    Krispy Kreme is recalling Signature Doughnuts, Half Dozen, due to the potential presence of glass. Consumers should discard the product.

    Product
    Krispy Kreme Doughnuts, Signature Doughnuts, Half Dozen, Net Wt. 9.5oz, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0200-2016·2015-11-11

    Medtronic Achieve Electrical Cables Recalled for Potential Sterility Breach

    Medtronic is recalling 64 units of Achieve Electrical Cables (Model 990066) due to a potential sterility breach. The sterile, single-use cables were distributed to facilities in 16 states and DC.

    Product
    Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and…
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-0141-2016·2015-11-11

    Krispy Kreme Glazed Raspberry Filled Doughnuts Recalled for Glass

    Krispy Kreme is recalling specific lots of Glazed Raspberry Filled Doughnuts because they may contain glass.

    Product
    Krispy Kreme Doughnuts, Glazed Raspberry Filled Doughnuts, 2 count, Net Wt. 4.65oz, and Half Dozen, Net Wt. 16 oz., Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0146-2016·2015-11-11

    Krispy Kreme Doughnut Holes Recalled for Potential Glass Contamination

    Krispy Kreme is recalling Original Glazed Doughnut Holes because the finished product may contain foreign matter, specifically glass.

    Product
    Krispy Kreme Doughnuts, Original Glazed Doughnut Holes, 2 count, Net Wt. 6.9 oz., Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0224-2016·2015-11-11

    Mako RIO Robotic System Components Recalled for Damaged Locking Pins

    Mako Surgical Corporation is recalling RIO system locking pins and connectors because the pins are damaged during assembly.

    Product
    Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2016·2015-11-11

    Siemens e.cam Gamma Camera Recall for Radial Brake Failure

    Siemens Medical Solutions is recalling e.cam Gamma Camera systems due to a potential radial brake failure that could allow the detector to drift.

    Product
    e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2016·2015-11-11

    Brainlab Patient Data Manager Software Recalled for Image Display Errors

    Brainlab AG is recalling Patient Data Manager software versions 2.0.0 through 2.1.0 because objects may display incorrectly when users deselect fused reference datasets.

    Product
    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2016·2015-11-11

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Reboot Issues

    Philips is recalling HeartStart MRx monitor/defibrillators because they may reboot unexpectedly, interrupting or delaying therapy.

    Product
    HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2016·2015-11-11

    Alcon Custom Pak 9319-27 Recalled for Latex Glove Mislabeling

    Alcon Research, Ltd. is recalling five units of Custom Pak 9319-27 ophthalmic surgical devices because they contain latex gloves despite being labeled as latex-free.

    Product
    Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0196-2016·2015-11-11

    GE Recalls MR Surgical Suite II Tables Due to Transfer Mechanism Issue

    GE Medical Systems is recalling MR Surgical Suite II Tables because a defect in the transfer release mechanism may prevent patient transfer between the MR and surgical tables.

    Product
    MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0209-2016·2015-11-11

    Otto Bock Triton Smart Ankle Recalled Due to Software Issue

    Otto Bock is recalling the Triton Smart Ankle and iOS Galileo app due to a software issue that can cause unexpected foot movement, posing a fall risk.

    Product
    iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2016·2015-11-11

    FDA Recalls Robotic Hand Accessories Due to Pinch Hazard

    Interactive Motion Technologies is recalling eight robotic hand accessories for the InMotion Arm rehabilitation robot due to a potential pinch hazard if protective covers are removed.

    Product
    Robotic hand accessory to InMotion Arm, rehabilitation robot.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0140-2016·2015-11-11

    Krispy Kreme Chocolate Iced Custard Filled Doughnuts Recalled for Glass

    Krispy Kreme is recalling Chocolate Iced Custard Filled Doughnuts because they may contain glass. Consumers should not eat the product.

    Product
    Krispy Kreme Doughnuts, Chocolate Iced Custard Filled Doughnuts, 2 count, Net Wt. 4.65oz, and Half Dozen, Net Wt. 16.2 oz., Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0194-2016·2015-11-11

    Baxter 15L Cycler Drainage Bags Recalled for Inlet Port Leakage

    Baxter Healthcare Corp. is recalling 19,440 units of 15L Cycler Drainage Bags due to leakage from the inlet port. The products were distributed in the US and Canada.

    Product
    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0221-2016·2015-11-11

    CareFusion Recalls SmartSite Extension Sets Due to Disconnection and Leakage

    CareFusion is recalling SmartSite Extension Sets because they may disconnect or leak. The recall affects 21,000 units distributed in the US and Canada.

    Product
    SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2016·2015-11-11

    GE Healthcare Recalls Centricity Universal Viewer Due to Inaccurate X-ray Measurements

    GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher because magnified projection X-ray images may display inaccurate distance measurements.

    Product
    The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0144-2016·2015-11-11

    Krispy Kreme Original Glazed Doughnuts Recalled for Potential Glass Contamination

    Krispy Kreme is recalling Original Glazed Doughnuts because they may contain foreign matter, specifically glass.

    Product
    Krispy Kreme Doughnuts, Original Glazed Doughnuts, 2 count, Net Wt. 3.5 oz., Half Dozen, Net Wt. 9.4oz and One Dozen, Net Wt. 18.7 oz., Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0225-2016·2015-11-11

    GE Healthcare Recalls Centricity PACS-IW Due to Inaccurate X-Ray Measurements

    GE Healthcare is recalling Centricity PACS-IW software because it may display inaccurate distance measurements for magnified projection X-ray images.

    Product
    The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2016·2015-11-11

    Exactech Recalls Eight Hip Implant Stems Lacking Coating

    Exactech is recalling eight Novation Element femoral hip implant stems that did not receive the specified Hydroxyapatite coating.

    Product
    Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0142-2016·2015-11-11

    Krispy Kreme Glazed Lemon Filled Doughnuts Recalled for Glass

    Krispy Kreme is recalling specific lots of Glazed Lemon Filled Doughnuts because they may contain glass.

    Product
    Krispy Kreme Doughnuts, Glazed Lemon Filled Doughnuts, (2 count, Net Wt. 4.65oz and Half Dozen, Net Wt. 16oz), Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0204-2016·2015-11-11

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Capacitor Degradation

    Philips is recalling 1,553 HeartStart MRx Monitor/Defibrillators because automated tests may degrade capacitors and the low battery indicator may fail.

    Product
    Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2016·2015-11-11

    FDA Recalls Regard Custom Surgical Packs Due to Flow Restriction Issues

    Resource Optimization & Innovation LLC is recalling 255 Regard Custom Surgical Packs due to flow restriction issues in the trifurcated IV set.

    Product
    Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
    Category
    Medical Device
    Distribution
    1 state