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.

38276–38300 of 50506

  • HighFDA (Devices)·Z-1875-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Defects

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2015·2015-07-08

    FDA Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects

    The FDA is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2015·2015-07-08

    GE Healthcare Recalls Innova 2121IQ Angiographic X-ray Systems

    GE Healthcare is recalling Innova 2121IQ angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2015·2015-07-08

    Pega Medical Recalls SCFE Drivers Due to Handle Detachment Risk

    Pega Medical Inc. is recalling four units of SCFE Drivers because the handle may detach from the shaft during use.

    Product
    Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-2785-2015·2015-07-08

    Sunridge Coconut Chews Recalled for Stainless Steel Wire Fragments

    Falcon Trading Co. is recalling Sunridge Coconut Chews due to the presence of stainless steel wire fragments in the shredded coconut.

    Product
    Sunridge Candy-Coconut Chews, Vanilla. 10 lb. box. Item code: 023617; UPC: 086700936177 Falcon Trading Company Inc/Sun Ridge Farms, Royal Oaks, CA
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1918-2015·2015-07-08

    New Star Lasers Recalls StoneLight 30 Laser Systems Due to Energy Discrepancy

    New Star Lasers is recalling 52 StoneLight 30 Laser Systems because a software issue may cause the delivered energy to differ from the displayed value.

    Product
    StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1978-2015·2015-07-08

    GE Healthcare Recalls Innova 3100IQ Angiographic X-ray Systems

    GE Healthcare is recalling six Innova 3100IQ angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2015·2015-07-08

    GE Healthcare Recalls Innova IGS 530 Angiographic X-ray Systems

    GE Healthcare is recalling 17 Innova IGS 530 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2015·2015-07-08

    GE Healthcare Recalls Angiographic X-ray Systems Due to Motion Loss

    GE Healthcare is recalling three Discovery and Innova IGS 740 angiographic X-ray systems because they may lose C-arm gantry motion capability.

    Product
    GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2015·2015-07-08

    Covidien Recalls Palindrome Precision SI Chronic Catheters for Antimicrobial Issues

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1893-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2015·2015-07-08

    GE Healthcare Radiographic Systems Recalled for Safety Mechanism Failure

    GE Healthcare is recalling Precision 500D and Advantx Legacy systems because a safety mechanism may fail to engage, posing a risk of injury from falling equipment.

    Product
    GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2015·2015-07-08

    GE Healthcare Recalls Innova 2100IQ Angiographic X-ray Systems

    GE Healthcare is recalling 13 Innova 2100IQ angiographic X-ray systems due to a potential safety issue that may cause the loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2015·2015-07-08

    Palindrome SI Chronic Catheter Recall for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1962-2015·2015-07-08

    Siemens Rapidlab 1265 Blood Gas Analyzer Recalled for Diagnostic Error Code Failure

    Siemens Healthcare Diagnostics is recalling 2,713 Rapidlab 1265 blood gas analyzers because specific diagnostic error codes are not functional.

    Product
    The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1884-2015·2015-07-08

    Recall of Palindrome Precision SI Chronic Catheters Due to Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119368P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1944-2015·2015-07-08

    Biomet Recalls Gentle Threads Interference Screws Due to Lot Mixing

    Biomet is recalling 53 units of Gentle Threads Interference Screws because they were mixed with a different size, posing a risk of surgical failure.

    Product
    Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1861-2015·2015-07-08

    FDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Specification Failure

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2015·2015-07-08

    FDA Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Failure

    The FDA is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2015·2015-07-08

    Roche Creatinine Plus Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Creatinine Plus reagent because it may produce falsely decreased results when used with certain drugs.

    Product
    Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2015·2015-07-08

    FDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Specification Failure

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z1856-2015·2015-07-08

    Palindrome SI Chronic Catheter Sport Pack Recalled for Antimicrobial Defect

    Covidien LLC is recalling Palindrome SI Chronic Catheter Sport Packs because they may not meet antimicrobial specifications.

    Product
    Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2015·2015-07-08

    Covidien Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2015·2015-07-08

    GE Healthcare Recalls Innova 3131IQ Angiographic X-ray Systems

    GE Healthcare is recalling two Innova 3131IQ angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide