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.

39751–39775 of 50506

  • HighFDA (Devices)·Z-0901-2015·2015-01-07

    Nonin Medical Recalls Regional Oximetry Sensors Due to Signal Loss

    Nonin Medical is recalling specific regional oximetry sensors because they may lose signal when used on diaphoretic patients. No injuries or illnesses have been reported.

    Product
    SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0892-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment

    Roche is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diabetes Care is recalling ACCU-CHEK Tender I infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2015·2015-01-07

    ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2015·2015-01-07

    ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2015·2015-01-07

    Bard Caliber Inflation Device Recalled for Pressure Limitations

    Perouse Medical is recalling Bard Caliber inflation devices that may fail to reach required pressure, potentially delaying angioplasty procedures.

    Product
    Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2015·2015-01-07

    Smiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure

    Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge safety hypodermic needles because the needle is not captured in the safety sheath.

    Product
    Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2015·2015-01-07

    Atricure CryoICE Cryogenic Probe Recalled for Potential Sterility Compromise

    Atricure Inc is recalling 19,190 CryoICE cryogenic probes due to packaging defects that may have compromised sterility.

    Product
    Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2015·2015-01-07

    Smiths Medical Needle Pro Edge Safety Device Recall for Uncaptured Needles

    Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge Safety Devices because the needle is not captured in the safety sheath.

    Product
    Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2015·2015-01-07

    ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V001000·2015-01-05

    MCI Recalls J4500 Motor Coaches Due to Brake Hose Wear Risk

    Motor Coach Industries is recalling 2013-2015 MCI J4500 motor coaches because a brake hose may rub against the tire or control arm, potentially causing a loss of braking power.

    Product
    MCI — MCI J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2015·2014-12-31

    Siemens ADVIA Centaur Laboratory Analyzer Recall for Tubing Crack Risk

    Siemens is recalling ADVIA Centaur laboratory analyzers because a slight crack in the tubing at the reservoir connector may occur due to mechanical stress.

    Product
    ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2015·2014-12-31

    Iris Diagnostics Recalls RTH8 Rotor for StatSpin Express 4 Centrifuge

    Iris Diagnostics is recalling RTH8 rotors for the StatSpin Express 4 Horizontal Centrifuge because the parts may develop cracks with use over time.

    Product
    RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0755-2015·2014-12-31

    Tricar Recalls Organic English Cucumbers Due to E. coli Contamination Risk

    Tricar Sales Inc is recalling specific lots of Organic English Cucumbers because they may be contaminated with E. coli. The affected products were distributed in Oregon, California, and Canada.

    Product
    Organic English Cucumber, 12 pieces per box, PLU 94593, UPC 8 24660 20100 9
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0856-2015·2014-12-31

    Horiba Lite DM Software Recall for Potential Data Mismatch

    Horiba Instruments is recalling Lite DM software versions 2.0.0.19 and lower due to a bug that may apply test results to the wrong patient order.

    Product
    Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2015·2014-12-31

    Bausch & Lomb Stellaris PC Vision Enhancement System Recalled for Software Anomaly

    Bausch & Lomb is recalling 79 Stellaris PC Vision Enhancement Systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.

    Product
    Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and…
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0837-2015·2014-12-31

    Mindray Recalls IBP Modules for DPM 6 and DPM 7 Patient Monitors

    Mindray is recalling IBP modules for DPM 6 and DPM 7 patient monitors because blood pressure data may display in the wrong screen tile.

    Product
    DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple…
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0874-2015·2014-12-31

    Ebi Solitaire-C Cervical Spacer Drill Sleeves Recalled for Design Deficiency

    Ebi, LLC is recalling 193 units of Solitaire-C Cervical Spacer System drill sleeves because a design defect allows instruments to penetrate 1.0 mm beyond intended depths.

    Product
    Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2015·2014-12-31

    Ion Beam Applications Recalls adaPT insight Software Due to Calibration Error

    Ion Beam Applications S.A. is recalling one unit of adaPT insight software in Pennsylvania due to a calibration file error and a gantry collision incident.

    Product
    adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0326-2015·2014-12-31

    Neolpharma Recalls Subpotent Alprazolam Tablets Nationwide

    Neolpharma, Inc. is voluntarily recalling 12,310 bottles of 0.25 mg alprazolam tablets nationwide because the medication was found to be subpotent.

    Product
    ALPRAZOLAM — ALPRAZOLAM (ALPRAZOLAM)
    Category
    Drug
    Distribution
    Distributed nationwide