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
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
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
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
Sagemax Bioceramics, Inc. NexxZr T Multi A3.5 W98-16mm, REF: 745451 recall: Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically…
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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
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 recall: Sterile anchors my lack sterility assurance
Sterile anchors my lack sterility assurance.
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Class II · 4 months ago
Micromed S.p.A. SD LTM 64 PLUS, EEG Amplifier/recorder, Model/ recall: Natus has become aware of two complaints related to the SD LTM 64 PLUS where
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a…
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Class II · 4 months ago
In2bones USA, LLC NeoSpan¿ SuperElastic Compression Staple w/Instruments recall: Due to the Magnetic Resonance Conditional Symbol missing on the carton
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
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Class II · 4 months ago
Boston Scientific CSK Electrodes: REF: Csk-Tc10 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
INSPIREMD Inc Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm 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
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: 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
Mozarc Medical US LLC Mahurkar Elite PASS Trays recall: The Tegaderm CHG dressing, as specified in product labeling
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
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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
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
Fresenius Medical Care Holdings, Inc. Bicarby Dialysate recall: There is an error in the labeling of the GTIN on the product. When scanned
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the…
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Class II · 4 months ago
GE Medical Systems, LLC Allia IGS 3 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
INSPIREMD Inc Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm 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 · 5 months ago
Baxter Healthcare Corporation Brand Name: Exacta Mix Product Name: Vented recall: Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow…
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Class II · 5 months ago
Philips Azurion 5M12, Model Numbers: 722227 with Software release recall: During the device phase of Roadmap Pro, a user may experience a dark image
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user…
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Class I · 5 months ago
B Braun Medical Inc Design Options Spinal Tray Spinal Needle Anesthesia procedure kits recall: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a…
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Class II · 5 months ago
CareFusion 303, Inc. BD Pyxis MedStation ES Tower REF: 352 Medication cabinet recall: Fingerprint scanner may overheat to a temperature to cause 1st degree burn
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.