Recall

All recalls7,869 total

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Private Label Skin Care Inc. — Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

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Private Label Skin Care Inc. — Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

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Private Label Skin Care Inc. — Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

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Medtronic Perfusion Systems — Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

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UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

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Philips North America — Cardiac Workstation 5000; Model Number: 860439;

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

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UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

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Argon Medical Devices, Inc — Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolis

Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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Diagnostica Stago, Inc. — Product: STA Liatest D-Di; REF: 00515;

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

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UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

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Philips North America — Cardiac Workstation 7000; Model Number: 860441;

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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TROPICANA BRANDS GROUP — Dole Apple Juice (primary package), 15.2 Fl oz., PET, 12 bottles per case, Refrigerate after opening

A manufacturing process deviation occurred which may cause spoilage or microbial contamination and affect shelf stability.

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Harris Teeter — Harris Teeter ASIAGO TEXAS TOAST, NET WT 5.0OZ (0.3lb), INGREDIENTS BREAD***CONTAINS WHEAT, UPC 0 72036 95364 3, Harris Teeter Raleigh, NC

Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.

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Harris Teeter — Harris Teeter CINNAMON TEXAS TOAST, NET WT 5.0oz (0.31g), INGREDIENTS BREAD*** CONTAINS WHEAT, UPC 0 72036 95734 4, Harris Teeter Raleigh, NC

Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.

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Medline Industries, LP — Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes

Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

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Olympus Corporation of the Americas — EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

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CareFusion 303, Inc. — BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

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Olympus Corporation of the Americas — OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

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Olympus Corporation of the Americas — BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

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Olympus Corporation of the Americas — OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

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