Recalls affecting California
Notices that name California in their distribution area, plus every nationwide recall — nationwide recalls reach California too.
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Class II · 2 months ago
Philips North America Llc Cardiac Workstation 5000. Product Number: 860439 recall: Device will intermittently provide inaccurate data related to native heart
Device will intermittently provide inaccurate data related to native heart rate.
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Class II · 2 months ago
Foundation Medicine, Inc. Hamilton Microlab STAR Liquid Handler recall: Software issue that can cause an increase in spontaneous software closures
Software issue that can cause an increase in spontaneous software closures.
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Class II · 2 months ago
Brand Name: Kico Knee Innovation Product Name: Arvis Surgical recall: Due to an internal sensor issue, image displayed with eyepiece may appear
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
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Class II · 2 months ago
Tobii Dynavox Llc TD Navio Midi Speech Generating Device Model/ recall: Under certain conditions, the battery mounting tabs may become damaged
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading…
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Class II · 2 months ago
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System recall: Due to a firmware defect, the portable organ transfer device datalogger
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed…
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Class II · 2 months ago
Siemens Healthcare Diagnostics, Inc. Syva EMIT 2000 Quinidine Assay REF: 4Q019UL recall: Due to unacceptable precision performance exhibited in certain lots
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated…
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Class II · 2 months ago
restor3d Inc. Brand Name: Veritas Standard Reverse Total Shoulder Product Name recall: Due to incorrect machining of peripheral screw hole resulting in potential
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
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Class II · 2 months ago
Gentherm Medical, LLC Blanketrol II Model 222S recall: Overheating of the 115V CPU board may cause the device to shut down
Overheating of the 115V CPU board may cause the device to shut down.
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Class II · 2 months ago
Siemens Healthcare Diagnostics, Inc. Beckman Coulter recall: Due to unacceptable precision performance exhibited in certain lots
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated…
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Class II · 2 months ago
Intersurgical Inc One-Piece Guedel Airway, size 00, ISO 5.0 recall: Devices could potentially be occluded or partially occluded
Devices could potentially be occluded or partially occluded.
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Class II · 2 months ago
AVID Medical, Inc. Halyard Lavh Pack, Model/ recall: The kit component was subjected to EO sterilization
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a…
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Class II · 2 months ago
Boston Scientific Corporation OverStitch Suture Cinch recall: Device may fail to deploy the cinch implant and/or fail to cut the suture
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
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Class II · 2 months ago
Intersurgical Inc One-Piece Guedel Airway, size 000, ISO 3.5 recall: Devices could potentially be occluded or partially occluded
Devices could potentially be occluded or partially occluded.
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Class II · 2 months ago
American Regent, Inc. Tralement , packaged in a) 1mL Single Dose vials and b) 5x1mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
American Regent, Inc. Cyanocobalamin injection USP, 1,000 mcg/mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
Sun Pharmaceutical Industries Inc Carbamazepine Tablets, USP, 200mg recall: CGMP Deviations; black spots found on tablets from burnt excipient during
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
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Class I · 2 months ago
Fresenius Kabi USA, LLC Morphine Sulfate Injection, USP, 2 mg /mL recall: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
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Class II · 2 months ago
American Regent, Inc. Selenious Acid Injection, USP 12 mcg/2 mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
American Regent, Inc. Aminaocaproic Acid Injection, USP, 250 mg/mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
American Regent, Inc. niCARdipine Hydrochloride Injection, USP, 25 mg/10mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
Shilpa Medicare Limited Pemrydi RTU , 500 mg/50 mL , Single-dose vial recall: Discolored solution. The firm has received market complaints reporting green
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
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Class II · 2 months ago
Mylan Pharmaceuticals Inc Acamprosate Calcium, Delayed-Release Tablets, 333 mg recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 2 months ago
American Regent, Inc. Nitroglycerin injection, USP, 50 mg/10 mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
Regeneron Pharmaceuticals Inc Libtayo Injection, 350 mg/7 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility