Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 8 months ago
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 recall: A potential weakness has been identified in the probe body
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the…
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Class II · 8 months ago
Brand Name: Aesculap Product Name: Minop Trocar 150MM 4 Wking recall: There is the potential for the length of the trocar shaft to be too long
There is the potential for the length of the trocar shaft to be too long.
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Class II · 8 months ago
Staar Surgical AG EVO+ Visian recall: Toric Implantable Collamer for correction/reduction of myopia in phakic eyes
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length…
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Class I · 8 months ago
Abiomed, Inc. Impella RP. Product Code: 0046-0011 recall: Differential pressure (dP) sensor in Impella RP devices may malfunction
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Class II · 8 months ago
B Braun Medical Inc Brand Name: B. Braun Product Name: 21GA Winged INF SET Model/ recall: The potential for the needle tip to be dull/blunt
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
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Class II · 8 months ago
Olympus Corporation of the Americas Brand Name: ShockPulse-SE Lithotripsy System recall: Ongoing investigations identified additional instances of the device
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer…
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Class I · 8 months ago
Abiomed, Inc. Impella RP with SmartAssist. Product Code: 0046-0035 recall: Differential pressure (dP) sensor in Impella RP devices may malfunction
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Class II · 8 months ago
Olympus Single Use Biopsy Valve. Model/ recall: Potential for rubber fragment detachment during use
Potential for rubber fragment detachment during use.
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Class I · 8 months ago
Abiomed, Inc. Impella RP Flex with SmartAssist. Product Code: 1000323 recall: Differential pressure (dP) sensor in Impella RP devices may malfunction
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Class II · 8 months ago
Olympus Single use Biopsy Valve. Model/ recall: Potential for rubber fragment detachment during use
Potential for rubber fragment detachment during use.
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Class II · 8 months ago
Agiliti Health - Ellis Adapt Pump, Model/ recall: Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump)
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the…
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Class II · 8 months ago
Medline Convenience Kits: 1) NAIL KIT recall: Medline has identified that the manufacturer of the sterile saline wound wash
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required…
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Class II · 8 months ago
Edermy LLC PIE Trolley System Model: 2005 recall: Lack of 510K clearance
Lack of 510K clearance
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Class II · 8 months ago
Olympus Inner Sheath, Long recall: Complaints of the ceramic tip of the resection sheath breaking have
Complaints of the ceramic tip of the resection sheath breaking have been received.
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Class II · 8 months ago
Brand Name: Hitachi Proton Beam Therapy REF: Probeat-Cr recall: Software anomaly in the patient positioning system may result in positional
Software anomaly in the patient positioning system may result in positional discrepancy.
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Class II · 8 months ago
Medline kits containing Tego Connectors Medline Apheresis Subqport recall: Affected lots may exhibit issues with the silicone seal on Tego Connectors
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal…
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Class II · 8 months ago
Olympus Inner Sheath recall: Complaints of the ceramic tip of the resection sheath breaking have
Complaints of the ceramic tip of the resection sheath breaking have been received.
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Class II · 8 months ago
Olympus Resection Sheath recall: Complaints of the ceramic tip of the resection sheath breaking have
Complaints of the ceramic tip of the resection sheath breaking have been received.
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Class II · 8 months ago
Medline Convenience Kits: 1) Trunk KIT W/Expiration recall: Medline has identified that the manufacturer of the sterile saline wound wash
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required…
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Class II · 8 months ago
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation recall: Medline has identified that the manufacturer of the sterile saline wound wash
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required…
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Class II · 8 months ago
Encore Medical, LP Brand Name: Empowr 3D Knee Product Name: Empowr 3D Knee INS recall: Knee and Humeral socket implants contain incorrect labeling
Knee and Humeral socket implants contain incorrect labeling.
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Class II · 8 months ago
Olympus Cystoscope Outer Sheath recall: Product being removed due to incompatibility when used in conjunction
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the…
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Class II · 8 months ago
Olympus Resection Sheath, 26 Fr recall: Complaints of the ceramic tip of the resection sheath breaking have
Complaints of the ceramic tip of the resection sheath breaking have been received.
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Class II · 8 months ago
Remel, Inc Campy CVA Medium 100/PK, R01272 recall: Customer complaints report low to no recovery of Campylobacter Jejuni ATCC
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.