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.

43651–43675 of 50511

  • HighFDA (Devices)·Z-1183-2013·2013-05-08

    B. Braun Recalls Diacap Ultra Dialysis Fluid Filters Due to Moisture Loss

    B. Braun Medical is recalling 1,580 Diacap Ultra Dialysis Fluid Filters because residual moisture may reduce over time, lowering membrane permeability.

    Product
    Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V183000·2013-05-08

    Autocar Recalls 2012-2013 ACX Trucks for Windshield Wiper Defect

    Autocar is recalling 797 model year 2012-2013 ACX trucks because insufficient welds may cause windshield wiper arms to fail, hindering driver vision.

    Product
    AUTOCAR — AUTOCAR ACX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2013·2013-05-08

    Stryker AxSOS Drill Bit Recalled Due to Incorrect Scale

    Stryker Orthopaedics is recalling AxSOS Calibrated Drill Bits because an incorrect scale may cause surgeons to select screws that are 10mm longer than intended.

    Product
    Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1000-2013·2013-05-08

    Trophy CareStream Dental CS 2200 X-ray System Recall for Bent Connector

    Trophy Sas is recalling CareStream Dental CS 2200 X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.

    Product
    CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2013·2013-05-08

    GE Healthcare Recalls CT Scanners Due to Heat Exchanger Bolt Defect

    GE Healthcare is recalling 166 CT scanners because improperly torqued heat exchanger bolts may cause parts to detach and spill oil.

    Product
    GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2013·2013-05-08

    Siemens Medical Solutions Recalls RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling RT Therapist software versions 4.2.108 to fix multiple safety-related issues on linear accelerator systems.

    Product
    Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2013·2013-05-08

    Vital Images Recalls Vitrea CT Brain Perfusion Software Due to User Confusion

    Vital Images is recalling Vitrea CT Brain Perfusion software versions 6.0 and above due to potential user confusion when viewing scans from wide coverage shuttle acquisition techniques.

    Product
    Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1192-2013·2013-05-08

    Owens & Minor Recalls MediChoice OB/GYN Applicators Due to Rayon Defect

    Owens & Minor is withdrawing MediChoice OB/GYN applicators because the rayon tip may loosen or unravel during use.

    Product
    MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2013·2013-05-08

    Medi-Trace Cadence Adult Defibrillation Electrodes Recalled for Thermal Damage Risk

    FDA is recalling Medi-Trace Cadence Adult Defibrillation Electrodes because arcing or sparking may cause thermal damage to the leadwire, potentially preventing the device from delivering appropriate energy to patients.

    Product
    Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V181000·2013-05-07

    Heartland Recalls 2013-2014 Trailers Due to Awning Motor Defect

    Heartland is recalling 2013-2014 travel and fifth-wheel trailers because awning motors may be damaged, causing the awning to unfurl unexpectedly and increasing injury or crash risk.

    Product
    HEARTLAND — HEARTLAND SUNDANCE XLT, BIG COUNTRY, LANDMARK, PROWLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V177000·2013-05-07

    Chrysler Recalls 2013 RAM 1500 Trucks for Defective Coolant Valve

    Chrysler is recalling 2013 RAM 1500 trucks because a stuck coolant valve may prevent the windshield defrosting system from working, increasing crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E023000·2013-05-02

    KONI Recalls Shock Absorbers with Incorrectly Welded Brackets

    KONI North America is recalling specific shock absorbers with incorrectly welded brackets that may bend and rest on the drive shaft, potentially compromising vehicle handling.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13183·2013-05-02

    Louisville Slugger OneX Fastpitch Softball Bats Recalled Due to Breakage Hazard

    Hillerich & Bradsby is recalling approximately 13,000 Louisville Slugger OneX Fastpitch softball bats because the barrel can separate from the handle during use, posing a risk of injury to nearby people.

    Product
    Louisville Slugger® OneX Fastpitch softball bat
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2013·2013-05-01

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Recalled for Software Error

    Beckman Coulter is recalling 490 AU5800 Clinical Chemistry Analyzers due to a software error that may cause the system to misidentify samples and report erroneous patient results.

    Product
    AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1154-2013·2013-05-01

    Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages

    Nova Biomedical Corporation is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.

    Product
    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2013·2013-05-01

    Ortho-Clinical Diagnostics Recalls VITROS Phenobarbital Slides Due to Accuracy Issues

    Ortho-Clinical Diagnostics is recalling VITROS Phenobarbital Slides because they may produce inaccurate, positively biased patient results that quality controls might miss.

    Product
    VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1321-2013·2013-05-01

    SIB, Inc. Recalls Bakehouse Granola for Undeclared Milk Allergen

    SIB, Inc. is recalling specific lots of Bakehouse Granola because the packaging fails to list milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    Bakehouse Granola, 12 oz, 340 g Scholar's Inn Bakehouse Granola 16 oz, 454 g All Natural, Baked locally
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1164-2013·2013-05-01

    GE Healthcare Recalls Xeleris 2 Workstation Due to Software Artifact Risk

    GE Healthcare is recalling 11 Xeleris 2 Processing & Review Workstations due to a software issue that may cause image artifacts in MPI studies, potentially leading to misdiagnosis.

    Product
    GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT)…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1165-2013·2013-05-01

    Philips NeuViz 16 CT Scanner Recalled Due to Pinch Hazard

    Philips and Neusoft are recalling 23 NeuViz 16 CT scanners because a user error could cause personnel injuries, including a reported finger pinch.

    Product
    NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1352-2013·2013-05-01

    Planet Food Recalls Yum Nature Tahini Due to Salmonella Risk

    Planet Food is recalling Yum Nature Tahini because it has the potential to be contaminated with Salmonella.

    Product
    Yum Nature Tahini, Net Wt. 18oz (1lb.2oz.)510g,12 jars/case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1339-2013·2013-05-01

    All One Active Senior Multiple Vitamin Powder Recalled for Mislabeling

    All One, Inc. is recalling 796 units of Active Senior Multiple Vitamin & Mineral Powder because the label incorrectly claims 'No Dairy' and 'Certified Vegan' despite containing whey protein isolate.

    Product
    all One Active Senior Multiple Vitamin & Mineral Powder dietary supplement, 30 Day Supply, 15.9 oz. canisters
    Category
    Food
    Distribution
    Distributed nationwide