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.

40701–40725 of 50511

  • HighFDA (Devices)·Z-2164-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2162-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2137-2014·2014-08-13

    Carestream KODAK DirectView DR 9000 X-Ray System Recalled for Control Failure

    Carestream Health is recalling KODAK DirectView DR 9000 systems because a control failure may cause the U-Arm to move downward unexpectedly at three times the normal speed.

    Product
    KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1515-2014·2014-08-13

    Sandoz Alprazolam Tablets Recalled for Stainless Steel Metal Particulates

    Mckesson Packaging Services is recalling Sandoz Alprazolam Tablets 0.25 mg due to the presence of stainless steel metal particulates.

    Product
    Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2156-2014·2014-08-13

    Stryker Recalls Sonopet Ultrasonic Surgical Systems Due to Irrigation Defect

    Stryker is recalling 2,460 Sonopet Ultrasonic Surgical Systems because insufficient irrigation to the tip can potentially lead to excessive heat.

    Product
    Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2303-2014·2014-08-13

    MuscleTech Amino Build Recalled for Potential Egg Cross-Contamination

    Milk Specialties Co is recalling two lots of MuscleTech Amino Build Fruit Punch due to potential cross-contamination with egg protein.

    Product
    MuscleTech Amino Build, Fruit Punch flavored, Net Wt. 0.58 lbs (261g) UPC 31646-70392 and Net Wt. 0.96 lbs (435g) UPC 31656-70479
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2140-2014·2014-08-13

    Ortho VITROS 4600 Chemistry System Recalled for Software Error

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2163-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Potential Fluid Leak

    ICU Medical is recalling 100 units of Transpac IT arterial monitoring kits because a component connection may crack and cause a fluid leak.

    Product
    Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2151-2014·2014-08-13

    Coltene Whaledent Recalls Latex Dental Dams Labeled as Non-Latex

    Coltene Whaledent Inc. is recalling latex dental dams that were incorrectly packaged in non-latex packaging, posing a risk to patients with latex allergies.

    Product
    Latex Dental Dams labeled as Non-Latex Dental Dams
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2165-2014·2014-08-13

    ICU Medical Recalls Transpac Arterial Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 50 units of Transpac arterial monitoring kits because a component connection may crack and cause a fluid leak.

    Product
    Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2158-2014·2014-08-13

    ICU Medical Recalls Trifurcated Transpac IT Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 40 units of Trifurcated Transpac IT Monitoring Kits because a component connection may crack and cause a fluid leak.

    Product
    Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2153-2014·2014-08-13

    PerkinElmer Recalls Panthera-Puncher 9 Sample Transfer Instruments

    PerkinElmer is recalling 144 Panthera-Puncher 9 sample transfer instruments because they may produce incorrect results from dried blood samples.

    Product
    Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2157-2014·2014-08-13

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 20 units of Transpac IV Trifurcated Monitoring Kits because a component connection may crack, causing a fluid leak.

    Product
    Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2160-2014·2014-08-13

    ICU Medical Recalls Trifurcated Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Trifurcated Transpac IV Monitoring Kits because a component connection may crack and cause a fluid leak.

    Product
    Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2166-2014·2014-08-13

    PerkinElmer Specimen Gate Software Recalled for Data Mismatch Risk

    PerkinElmer is recalling Specimen Gate Screening Center software versions 1.4 and 1.6 due to a potential mismatch between demographic information and test results.

    Product
    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2146-2014·2014-08-13

    Brainlab ExacTrac Software Recall for Potential Radiation Misalignment

    Brainlab AG is recalling ExacTrac v6.0.4 software because it may move patients to the wrong position during radiation treatment, potentially delivering the dose to an unintended target.

    Product
    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2161-2014·2014-08-13

    ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

    ICU Medical is recalling 200 arterial monitoring kits because a component connection may crack, causing a fluid leak.

    Product
    Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid…
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·14254·2014-08-12

    CoScentrix Recalls DD Brand Tin Candles Due to Fire Hazard

    CoScentrix is recalling DD Brand tin candles sold at Hobby Lobby because the high flame can ignite the wax and container, posing a fire hazard.

    Product
    DD Brand Tin Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V495000·2014-08-11

    Ford Recalls 2013-2014 Focus and Escape Vehicles for Wiring Defect

    Ford is recalling 2013-2014 Focus ST and Escape vehicles with 2.0-liter engines because a wiring defect may cause the engine to stall, increasing crash risk.

    Product
    FORD — FORD FOCUS, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V488000·2014-08-08

    GM Recalls 2013 Buick Encore and Cadillac ATS for Seat Belt Defect

    General Motors is recalling 2013 Buick Encore and Cadillac ATS vehicles because front lap belt pretensioner cables may not lock, increasing injury risk in a crash.

    Product
    CADILLAC — CADILLAC, BUICK ATS, ENCORE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V491000·2014-08-08

    All Wheel Recalls 2011-2012 Ford F-550 Chassis Due to Fire Risk

    All Wheel is recalling 2011-2012 Ford F-550 Super Duty chassis with 6.8L gasoline engines due to a PTO oil leak that poses a fire risk.

    Product
    SUPER DUTY — SUPER DUTY F-550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V489000·2014-08-08

    GM Recalls 2014-2015 Chevrolet Impala for Storage Console Latch Defect

    General Motors is recalling 2014-2015 Chevrolet Impala vehicles because the center storage console may not stay latched during a crash, increasing injury risk.

    Product
    CHEVROLET — CHEVROLET IMPALA
    Category
    Vehicle
    Distribution
    Distributed nationwide