Latest recalls — page 63
Older notices, newest first.
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Class II · 3 months ago
Daavlin Distributing Company Photera 400, phototherapy device recall: Calibrated Output was not calculating correctly - UV Sensor GAIN being
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at…
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Class I · 3 months ago
Oscor Inc. Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away recall: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along…
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Class II · 3 months ago
Olympus Ellik Evacuator Includes Glass Body recall: Some sterilization parameters included in the IFU may not consistently render
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used…
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Class I · 3 months ago
Abiomed Impella CP Introducer Kit 14 Fr, 13 and 25 cm recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class II · 3 months ago
GE Medical Systems, LLC Optima XR200amx, Mobile Digital-Ready Radiographic System recall: GE HealthCare has become aware that in certain Optima XR200/220/240amx
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of…
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Class II · 3 months ago
Daavlin Distributing Company Photera 600 3-D, phototherapy device recall: Calibrated Output was not calculating correctly - UV Sensor GAIN being
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at…
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Class II · 3 months ago
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) recall: In a specific scenario, the pump will not decrement the Volume to be Infused
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the…
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Class I · 3 months ago
Abiomed Impella CP Introducer Kit 14 Fr, 13 cm recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class II · 3 months ago
Papablic Replacement Brush Heads recall: Potential for brush heads to break
Potential for brush heads to break.
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Class II · 3 months ago
Papablic Replacement Brush Heads recall: Potential for brush heads to break
Potential for brush heads to break.
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Class I · 3 months ago
Abiomed Impella CP Set, Pump Set Code 0048-0003 recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class II · 3 months ago
Boston Scientific Corporation Rapid Refill Continuous Injection System, UPN M00566001 recall: Devices contain recalled Medline Namic Angiographic Control Syringe
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from…
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Class II · 3 months ago
Orthofix Minirail, Standard Lengthener Model/ recall: Unilateral external fixation devices may be incorrectly labeled. Minirail
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail…
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Class II · 3 months ago
Bell Pharmaceuticals, Inc Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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Class II · 3 months ago
Bell Pharmaceuticals, Inc Good Neighbor Pharmacy, Carbamide Peroxide 6.5%, 0.5 Fl Oz recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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Class II · 3 months ago
Bell Pharmaceuticals, Inc Audiologist's Choice, Carbamide Peroxide 6.5% recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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Class II · 3 months ago
Bell Pharmaceuticals, Inc TopCare Health, Carbamide Peroxide 6.5% recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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Class II · 3 months ago
Bell Pharmaceuticals, Inc CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz , a) Bottle recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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Class II · 3 months ago
Bell Pharmaceuticals, Inc meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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Class II · 3 months ago
Padagis US LLC Nystatin Cream USP recall: Subpotent Drug: Low out of specification assay results performed during
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
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Class II · 3 months ago
Bell Pharmaceuticals, Inc CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ , Bottle recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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Class II · 3 months ago
CareFusion 213, LLC BD ChloraPrep Clear, and 70% v/v isopropyl alcohol) recall: Lack of Assurance of Sterility: Affected product may exhibit an open
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
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Class II · 3 months ago
Bell Pharmaceuticals, Inc Family Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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Class II · 3 months ago
Bell Pharmaceuticals, Inc Leader, Carbamide Peroxide 6.5%, 0.5 Fl Oz recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).