Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: Corflo Safety PEG Kit with ENFit Connector Model/ recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
ICU Medical, Inc. Plum Duo Precision IV Pump, 40002-0403 recall: Under certain conditions, the pump may not display a soft limit alert
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming…
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
Avanos Medical, Inc. Brand Name: Corflo Product Name: Corflo* Safety PEG Kit Model/ recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: Corflo* Safety PEG Kit Model/ recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
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Class II · 4 months ago
HF Acquisition Co LLC Brand Name: Sporetraq Mail-In Spore Testing Service recall: Due to incorrect incubation process being performed on product
Due to incorrect incubation process being performed on product.
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Class II · 4 months ago
GE Medical Systems, LLC Allia IGS 5 Pulse angiographic X-ray system recall: GE HealthCare has become aware of a potential issue affecting an electrical
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue…
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Class II · 4 months ago
Siemens Dimension Tacrolimus Flex Reagent Cartridge , REF DF207 recall: A potential positive bias in quality control (QC) and patient sample results
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
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Class II · 4 months ago
INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/ recall: Stent delivery system may encounter complications during deployment
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
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Class II · 4 months ago
Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, Nitinol recall: Reusable electrodes may not meet expected performance levels
Reusable electrodes may not meet expected performance levels.
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Class II · 4 months ago
Elekta, Inc. Mosaiq Oncology Information System recall: Software may fail to load adapted baseline shift plan during treatment
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
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Class II · 4 months ago
HF Acquisition Co LLC Brand Name: Sporetraq Mail-In Spore Testing Service recall: Due to incorrect incubation process being performed on product
Due to incorrect incubation process being performed on product.
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Class II · 4 months ago
GE Medical Systems, LLC Allia Moveo angiographic X-ray system recall: GE HealthCare has become aware of a potential issue affecting an electrical
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue…
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Class II · 4 months ago
AVID Medical, Inc. Halyard, Pain Pack. Kit Code: AMPK48-01 recall: Inadvertent distribution of sealed pouches that had not undergone validated
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
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Class II · 4 months ago
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. TDC Veloce" recall: An increase in incidence in complaints of a loose outer knife and reports
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
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Class II · 4 months ago
GE Medical Systems, LLC Allia IGS Pulse angiographic X-ray system recall: GE HealthCare has become aware of a potential issue affecting an electrical
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue…
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Class II · 4 months ago
The Binding Site Group, Ltd. Brand Name: Exent Analyser Product Name: Exent Analyser recall: It was reported that plates 2 and 3 were marked as passed
It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples…
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
-
Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
-
Class II · 4 months ago
AVID Medical, Inc. Halyard, Towel Six Pack. Kit Code: AMTS70-01 recall: Inadvertent distribution of sealed pouches that had not undergone validated
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
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Class II · 4 months ago
Avanos Medical, Inc. Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG recall: Lidocaine hydrochloride injection, the subject of a supplier recall
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
-
Class II · 4 months ago
Fresh Roast Systems ColorTrack. Model Name: ColorTrack recall: A defect has been identified in the manufacture of the Fresh Roast Systems
A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare…