Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class I · 5 months ago
Becton Dickinson & Company BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 recall: This is a sub-recall of a product recall from Huons Co, Ltd
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is…
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Class I · 5 months ago
Becton Dickinson & Company BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 recall: This is a sub-recall of a product recall from Huons Co, Ltd
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is…
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Class I · 5 months ago
B Braun Medical Inc Spinal Needle procedure kits: Material Description 24GA. Pencan 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
Oculus Technologies of Mexico, S.A. de C.V. PhaseOne Antimicrobial Solution, Model/ recall: The recall is being conducted due to corrosion of the internal metallic
The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material…
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Class I · 5 months ago
Becton Dickinson & Company BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 recall: This is a sub-recall of a product recall from Huons Co, Ltd
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is…
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Class I · 5 months ago
Becton Dickinson & Company BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 recall: This is a sub-recall of a product recall from Huons Co, Ltd
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is…
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Class II · 5 months ago
Grace Medical, Inc. Titanium/Fluoroplastic Piston 0.6MM DIA X 3.75MM L Model/ recall: Due to incorrect functional length on device labeling
Due to incorrect functional length on device labeling.
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Class II · 5 months ago
Philips Azurion 7M20, Model Numbers: 722079 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 II · 5 months ago
Siemens Medical Solutions USA, Inc Artis Icono biplane recall: During patient examinations, the system may sporadically display a 0 x-ray
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed…
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Class II · 5 months ago
Philips Azurion 5M20, Model Numbers: 722228 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 II · 5 months ago
B Braun Medical Inc Brand Name: B. Braun Medical INC. Product Name: Bpsk recall: B. Braun was notified by our supplier, Ferndale Laboratories, Inc
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary…
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Class II · 5 months ago
CareFusion 303, Inc. BD Pyxis MedStation ES REF: 323 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.
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Class II · 5 months ago
Philips Azurion 7M12, Model Numbers: 722078 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 II · 5 months ago
Covidien Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN recall: Due to customer complaint regarding incorrect display box labeling
Due to customer complaint regarding incorrect display box labeling.
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Class II · 5 months ago
B Braun Medical Inc Brand Name: B. Braun Medical INC. Product Name: NES1725Kfxl recall: B. Braun was notified by our supplier, Ferndale Laboratories, Inc
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary…
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Class II · 5 months ago
Advanced Bionics, LLC Brand Name: HiResolution" Bionic Ear System Product Name: HiRes recall: Due to incorrect shelf-life expiration date
Due to incorrect shelf-life expiration date.
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Class II · 5 months ago
CareFusion 303, Inc. BD Pyxis Anesthesia Station 4000 REF: 338 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.
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Class II · 5 months ago
B Braun Medical Inc Brand Name: B. Braun Medical INC. Product Name: Cesk Shands recall: B. Braun was notified by our supplier, Ferndale Laboratories, Inc
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary…
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Class II · 5 months ago
GE Medical Systems China Co., Ltd. MAC 5 A4 Resting ECG Analysis System 855001-001 recall: Software in development inadvertently made available for customer use. Use
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being…
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Class II · 5 months ago
Philips Azurion 7B12/12, Model Numbers: 722067 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 II · 5 months ago
Daavlin Distributing Company Phothera 200, Phototherapy Devices indicated for use recall: Some of the Calibration/Output Certificates had the outputs reversed
Some of the Calibration/Output Certificates had the outputs reversed.
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Class I · 5 months ago
Kayserbetten Gmbh & Co. Kg Pediatric care bed recall: If the adjustment functions of the hand control
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is…
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Class II · 5 months ago
Stryker Corporation Neptune Smart Docking Station recall: It has been identified that the impacted docking station (SN 2521008873)
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed…
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Class II · 5 months ago
Kico Knee Innovation Company Arvis Hip & Knee 3.0 Instrument Set recall: The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.