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.

28276–28300 of 50488

  • HighFDA (Devices)·Z-2453-2018·2018-07-25

    Ethicon Prolene Suture Recall 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 36"(90CM) 4-0 BLUE, D7768
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2434-2018·2018-07-25

    AesDex Cardica C-Port Flex-A PLUS Distal Anastomosis System Recalled for Handle Damage

    AesDex is recalling the Cardica C-Port Flex-A PLUS Distal Anastomosis System because the handle mechanism may be damaged during use, potentially causing plastic fragments to disperse.

    Product
    AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. The stainless steel clips…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2449-2018·2018-07-25

    Ethicon Proline Suture Recall Due to Packaging Perforation Risk

    Ethicon is recalling 1,728 units of Proline suture because a packaging design issue allows needles to perforate the package, posing injury and infection risks.

    Product
    PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2488-2018·2018-07-25

    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 with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2490-2018·2018-07-25

    Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

    Cardinal Health 200, LLC 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 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • HighNHTSA·18E061000·2018-07-25

    Rock Run Recalls LP Bottle Ring Brackets for Propane Tank Safety

    Rock Run Industries is recalling LP Bottle Ring Brackets that may break, potentially causing propane cylinders to fall from vehicles.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS:TANK ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0948-2018·2018-07-25

    Avella Recalls Heparin Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 40 bags of Heparin 1,000 Units in NS 250mL due to potential leakage that compromises sterility.

    Product
    HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2018·2018-07-25

    Zeiss UV Disinfection Unit Recalled for Potential Radiation Exposure

    Zeiss is recalling 8 UV disinfection units for the Celldiscoverer 7 microscope because a firmware issue may allow the unit to activate outside its housing, exposing users to harmful UV radiation.

    Product
    Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2487-2018·2018-07-25

    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 with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2471-2018·2018-07-25

    Tandem t:slim G4 Insulin Pump Recalled for Inaccurate Battery Readings

    Tandem Diabetes Care is recalling 55 t:slim G4 Insulin Pumps because the fuel gauge may provide inaccurate battery readings, causing the pump to stop delivering insulin.

    Product
    t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Food)·F-1656-2018·2018-07-25

    Odwalla Superfood Fruit Smoothie Recalled for Potential Metal Fragments

    The Coca-Cola Company is recalling Odwalla Superfood fruit smoothies due to the potential for tiny wire metal fragments in the bottles.

    Product
    Odwalla Superfood fruit smoothie 15.2 oz. (450mL) plastic bottle; Sold in 8 pack case Unit UPC: 000-14054-06405-5 Odwalla Life Food- Canada only - Unit UPC: 000-14054-03125-5 Ingredients: Apple Juice from concentrate, peach and mango purees from concentrate, banana…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-2495-2018·2018-07-25

    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, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2507-2018·2018-07-25

    Medtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component

    Medtronic is recalling Tri-Staple 2.0 Black Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2018·2018-07-25

    Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

    Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

    Product
    Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2485-2018·2018-07-25

    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 with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2491-2018·2018-07-25

    Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

    Cardinal Health 200, LLC 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 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2433-2018·2018-07-25

    AesDex Cardica C-Port xA PLUS Anastomosis System Recalled for Handle Damage

    AesDex is recalling 587 Cardica C-Port xA PLUS Anastomosis Systems because the handle mechanism may break during use, causing a loud noise and potential dispersion of plastic fragments.

    Product
    AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2454-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling 588 units of Proline Suture Blue 4x18" 5/0 due to a packaging design issue that may allow the needle to perforate the package, posing a risk of injury or infection.

    Product
    PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Drugs)·D-0949-2018·2018-07-25

    Avella Recalls Hydromorphone Syringes Due to Sterility Concerns

    Avella of Deer Valley is recalling 480 single-dose hydromorphone syringes due to potential bag leakage and lack of sterility assurance.

    Product
    HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-63
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2492-2018·2018-07-25

    Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

    Cardinal Health 200, LLC 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, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Sterile. .
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2452-2018·2018-07-25

    Ethicon Recalls Certain Proline Sutures Due to Packaging Design Issue

    Ethicon is recalling specific Proline sutures because a packaging design issue allows the needle to perforate the package, posing a risk of injury or infection.

    Product
    PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2460-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

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

    Product
    PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2446-2018·2018-07-25

    NewDeal Large QWIX Medical Device Recalled Due to Infection Risk

    NewDeal SA is recalling Large QWIX medical devices because their use may cause superficial or deep infections requiring antibiotic treatment or device removal.

    Product
    Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2455-2018·2018-07-25

    Ethicon Recalls Certain Prolene Sutures Due to Packaging Design Issue

    Ethicon, Inc. is recalling 432 units of Prolene Suture 30" 8-0 Blue (D8292) because the needle may perforate the packaging, posing a risk of injury or infection.

    Product
    PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2486-2018·2018-07-25

    Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

    Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

    Product
    Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states