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.

34976–35000 of 50502

  • HighCPSC·16248·2016-08-23

    ALEX Toys Recalls Infant Building Sets Due to Choking Hazard

    ALEX Toys is recalling three infant building sets because small parts can detach, posing a choking hazard to young children.

    Product
    ALEX Jr. Baby Builder, First Pops and First Snaps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16247·2016-08-23

    McDonald's Recalls Step-iT Activity Wristbands Due to Skin Irritation Risk

    McDonald's is recalling Step-iT activity wristbands because they can cause skin irritation or burns. Consumers should remove the bands from children and return them for a free replacement.

    Product
    Step-iT Activity Wristbands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V609000·2016-08-22

    Keystone Recalls 2017 Cougar Trailers for Incorrect Tire Load Range

    Keystone is recalling 2017 Cougar recreational trailers because they may have incorrect Federal Identification Tags or tires with the wrong load range, which could lead to tire failure.

    Product
    KEYSTONE — KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2016·2016-08-17

    Edan Diagnostics Recalls EtCO2 Modules for Incorrect CO2 Readings

    Edan Diagnostics is recalling 521 EtCO2 modules used in patient monitors because they may provide incorrect CO2 readings.

    Product
    EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2016·2016-08-17

    Merge PACS software recalled due to patient name mismatch

    Merge Healthcare is recalling PACS software versions V6.0.2.0 MR2 and earlier because patient names in the interface do not match the displayed images.

    Product
    Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2016·2016-08-17

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of 'Stapler Firing Failed' messages.

    Product
    STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1918-2016·2016-08-17

    Williams Chipotle Chili Seasoning Recalled for Undeclared Wheat Allergen

    CH Guenther & Sons, Inc. is recalling Williams Chipotle Chili Seasoning because it contains undeclared wheat, a major allergen not listed on the label.

    Product
    Williams Chipotle Chili Seasoning, Net Wt. 1 1/8 OZ. (32 g). Williams Foods, Inc. Lenexa, KS 66215. Packaged in paper pouches.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2525-2016·2016-08-17

    Siemens Stratus CS STAT Fluorometric Analyzer Software Defect Recall

    Siemens is recalling Stratus CS STAT Fluorometric Analyzers due to a software defect that may cause inaccurate test results or out-of-range values when TestPaks are near expiration.

    Product
    Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2397-2016·2016-08-17

    Zimmer Biomet Recalls Zyston Transform Instrument Cases Due to Locking Defect

    Zimmer Biomet Spine, Inc. is voluntarily recalling Zyston Transform Instrument Cases and Implant Kits because the implant locking mechanism is not functioning as intended.

    Product
    Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1920-2016·2016-08-17

    Baptista's Bakery Recalls Snack Factory Pretzel Crisps for Undeclared Milk

    Baptista's Bakery is recalling Snack Factory Original Pretzel Crisps because they may contain undeclared milk. The product was distributed in eight US states and Canada.

    Product
    Snack Factory Original Pretzel Crisps, Thin, Crunchy Pretzel Crackers. Made in a facility that processes Milk and Soy. Distributed by: Snack Factory, PO Box 6917, Hanover, PA 17331 Sold in the following sizes and UPC codes: 12 ct / 116 oz. Net Wt 26 oz (l lb 10…
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1915-2016·2016-08-17

    Sundae Shoppe Ice Cream Cones Recalled for Undeclared Peanuts

    Mister Cookie Face is recalling Sundae Shoppe Novelty Ice Cream Dipped Variety cones because they may contain undeclared peanuts.

    Product
    Sundae Shoppe Novelty Ice Cream Dipped "Variety"cones, 32 oz. box, Manufactured by Mister Cookie Face LLC, Lakeland, NJ and Distributed by Aldi, Batavia, IL 60510, UPC 041498191962
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2374-2016·2016-08-17

    Teleflex Servo Humidifier 163 Recalled Due to Connector Cracks

    Teleflex Medical is recalling Servo Humidifier 163 units because cracks may occur at the ISO female connectors.

    Product
    Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2016·2016-08-17

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of firing failures.

    Product
    CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2348-2016·2016-08-17

    Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Firing Failures

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 devices due to an increased trend of stapler firing failures.

    Product
    STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2385-2016·2016-08-17

    Philips Ingenuity CT Software Recall for Performance Issues

    Philips Medical Systems is recalling 205 Ingenuity CT units due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.

    Product
    Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2376-2016·2016-08-17

    Hill-Rom Recalls Volker Series Hospital Beds Due to Side Rail Defect

    Hill-Rom is recalling Volker 2080, 2082, S 280, and S 282 series hospital beds because the side rail latch may fail, causing the rail to lower and the patient to fall.

    Product
    Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16245·2016-08-17

    Xenith Recalls Football Helmets Due to Shell Cracking Hazard

    Xenith is recalling specific football helmets because the shells can crack, posing a risk of head injuries. No injuries have been reported.

    Product
    Football helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2396-2016·2016-08-17

    Stryker Recalls Exeter Rasp Handle Due to Malfunctioning

    Stryker Howmedica Osteonics Corp. is recalling 241 Exeter Rasp Handles because they may malfunction during use.

    Product
    Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2398-2016·2016-08-17

    Zimmer Biomet Recalls Zyston Transform Implant Kits Due to Locking Defect

    Zimmer Biomet Spine is recalling five Zyston Transform Implant Kits because the locking mechanism is not functioning as intended.

    Product
    Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2016·2016-08-17

    Philips MX 16-slice CT Systems Recalled for Software Defects

    Philips is recalling 80 MX 16-slice CT systems due to software bugs that may cause image mix-ups or scan interruptions.

    Product
    MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2363-2016·2016-08-17

    Merge PACS software recall for inconsistent mammography lesion measurements

    Merge Healthcare is recalling specific versions of Merge PACS software because lesion measurements differ between unmagnified and magnified mammography images.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2373-2016·2016-08-17

    Ivoclar Vivadent Recalls OptraPol Dental Polishing Discs Due to Breakage

    Ivoclar Vivadent is recalling OptraPol polishing discs and cups because parts break away during use. The recall covers 86 units distributed in 16 states.

    Product
    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and…
    Category
    Medical Device
    Distribution
    16 states