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.

28301–28325 of 50488

  • HighFDA (Devices)·Z-2459-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue

    Ethicon, Inc. is recalling specific Prolene suture products because a packaging design issue allows the needle to perforate the package, posing a risk of injury or infection.

    Product
    PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2493-2018·2018-07-25

    Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

    Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

    Product
    Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Manufactured For Cardinal Health, Waukegan, IL.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2451-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue

    Ethicon, Inc. is recalling specific Prolene suture products because a packaging design issue allows the needle to perforate the package, posing a risk of injury or infection.

    Product
    PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2450-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue

    Ethicon is recalling specific Prolene suture products because a packaging design issue allows needles to perforate the package, posing a risk of injury or infection.

    Product
    PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2465-2018·2018-07-25

    Ethicon Recalls PRONOVA Suture Needles Due to Packaging Perforation Risk

    Ethicon is recalling specific PRONOVA suture needles because a packaging design issue may allow the needle to perforate the package, posing injury or infection risks.

    Product
    PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Drugs)·D-0930-2018·2018-07-25

    Avella Recalls Ephedrine Syringes Due to Potential Sterility Issues

    Avella of Deer Valley is recalling specific lots of ePHEDrine 50mg syringes because bags may leak, compromising sterility.

    Product
    ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2458-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Proline sutures because a packaging design issue allows needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2461-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Prolene suture products because a packaging design issue may allow needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2463-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Proline suture products because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.

    Product
    PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2479-2018·2018-07-25

    Hitachi Oasis MRI Systems Recalled for Exposed Belt Hazard

    Hitachi Medical Systems America Inc is recalling 264 Oasis MRI systems because an exposed stainless steel belt can cause finger cuts.

    Product
    Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0944-2018·2018-07-25

    Avella Recalls Fentanyl and Bupivacaine Cassettes Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 15 cassettes of fentanyl and bupivacaine due to potential bag leakage and lack of sterility assurance.

    Product
    fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2018·2018-07-25

    GE Medical Systems Recalls T2100 Microflex Drive Treadmill Units

    GE Medical Systems is recalling T2100 Microflex Drive Treadmills because unaddressed spare parts may cause uncontrolled walking belt motion during stress tests.

    Product
    T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling 372 units of Proline Suture Blue 18" 7-0 because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.

    Product
    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2462-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Prolene suture products because a packaging design issue allows needles to perforate the package, posing risks of soft tissue injury or infection.

    Product
    PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2457-2018·2018-07-25

    Ethicon Recalls Prolene Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Prolene suture units because a packaging design issue allows needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2316-2018·2018-07-25

    Wescam MX-10 Surveillance Laser System Recalled for Ocular Hazard

    Wescam Inc is recalling 29 MX-10 surveillance laser systems because the ocular hazard distance is longer than specified, posing a risk of eye exposure.

    Product
    MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2448-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling specific Proline suture products because a packaging design issue allows needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2437-2018·2018-07-25

    Siemens Dimension Vista MULTI 1 SDIL Diluent Recall for Defective Septum

    Siemens is recalling 197 units of Dimension Vista MULTI 1 SDIL diluent due to a potential defect in the vial cap septum that may cause inaccurate test results.

    Product
    Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2447-2018·2018-07-25

    NewDeal TIBIAXYS Medical Device Recalled Due to Infection Risk

    NewDeal SA is recalling TIBIAXYS devices because use may cause superficial or deep infections requiring antibiotic treatment or device removal.

    Product
    TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1651-2018·2018-07-25

    TR Toppers Chopped Chocolate Pretzel Pieces Recalled for Peanut Contamination

    T R Toppers, Inc. is recalling Chopped Chocolate Pretzel Pieces due to potential peanut contamination. Consumers should check for Lot 10481 and stop using the product.

    Product
    TR Toppers Brand Chopped Chocolate Pretzel Pieces. Item number B160-075 GTIN 0 06 51844 10599 6, 7.5 Lbs. (3 x 2.5 Lbs. Bags), Best Kept Between 34¿F and 40¿F <50% Relative Humidity
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling 300 units of Proline Suture 30" 6-0 Blue because a packaging design issue may allow the needle to perforate the package, posing injury or infection risks.

    Product
    PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
    Category
    Medical Device
    Distribution
    25 states
  • HighCPSC·18192·2018-07-24

    JCPenney Recalls Okie Dokie Shorts Due to Choking Hazard

    JCPenney is recalling Okie Dokie Denim Patches Shortie shorts because the patches can detach, posing a choking hazard to young children.

    Product
    Okie Dokie Denim Patches Shortie shorts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18190·2018-07-24

    Ross Stores Recalls Bistro Chairs Due to Frame Breakage and Fall Hazard

    Ross Stores is recalling Bronze Hammered bistro chairs because the frames can break, posing a fall hazard. Consumers should stop using the chairs and return them for a full refund.

    Product
    Bistro chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V488000·2018-07-23

    Karma Revero Recalled for Non-Compliant Driver Side Rearview Mirror Glass

    Karma Automotive is recalling 2018 Revero vehicles because the driver's side exterior rearview mirror may use convex glass instead of flat glass, failing federal safety standards.

    Product
    KARMA — KARMA REVERO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V472000·2018-07-20

    Van-Con Recalls School Buses Due to Seat Foam Crash Protection Defect

    Van-Con is recalling 2011-2018 33803 Dual Rear Wheel school buses because seat foam may not absorb enough impact in a crash, increasing injury risk.

    Product
    VAN-CON — VAN-CON 33803 DUAL REAR-WHEEL
    Category
    Vehicle
    Distribution
    Distributed nationwide