Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 5 months ago
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001 recall: A limited number of Pocket Adaptor Kits, Model 64001 and 64002
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
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Class I · 5 months ago
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose recall: Medline kits were distributed containing Huons Bupivacaine Hydrochloride
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality…
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Class I · 5 months ago
Bolton Medical Inc. RelayPro Thoracic Stent-Graft System Reference numbers recall: Labeling update concerning proximal clasp disconnection from the outer
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the…
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Class I · 5 months ago
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose recall: Medline kits were distributed containing Huons Bupivacaine Hydrochloride
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality…
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Class II · 5 months ago
Medline medical convenience kit labeled as EYE Tray-Lf recall: Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes…
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Class I · 5 months ago
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose recall: Medline kits were distributed containing Huons Bupivacaine Hydrochloride
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality…
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Class I · 5 months ago
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose recall: Medline kits were distributed containing Huons Bupivacaine Hydrochloride
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality…
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Class I · 5 months ago
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose recall: Medline kits were distributed containing Huons Bupivacaine Hydrochloride
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality…
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Class II · 5 months ago
GE Medical Systems Information Technologies Inc GE HealthCare ApexPro v6.0 eDelivery recall: GE HealthCare has become aware of an unlikely situation where potential loss
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server…
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Class I · 5 months ago
Abiomed, Inc. Automated Impella Controller with the below product descriptions recall: Retrospective submission for following issues identified: 1. Alarm failures
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current…
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Class I · 5 months ago
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose recall: Medline kits were distributed containing Huons Bupivacaine Hydrochloride
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality…
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Class I · 5 months ago
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose recall: Medline kits were distributed containing Huons Bupivacaine Hydrochloride
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality…
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Class II · 5 months ago
GE Medical Systems Information Technologies Inc GE HealthCare Trade IN Carescape recall: GE HealthCare has become aware of an unlikely situation where potential loss
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server…
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Class II · 5 months ago
Becton, Dickinson and Company Swan-Ganz Catheter, Models: 131F7/131F7P recall: Catheters may, due to a manufacturing process and material changes
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to…
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Class II · 5 months ago
Medtronic Gundry Retrograde Cannula Manual-Inflate Silicone Body 15FR recall: Certain lots of product have the potential for a sterile barrier breach
Certain lots of product have the potential for a sterile barrier breach.
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Class II · 5 months ago
ICU Medical, Inc. Oncology Kit w/60" Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port recall: Oncology sets/closed system transfer devices with extension sets may leak
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if…
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Class II · 5 months ago
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR recall: Certain lots of product have the potential for a sterile barrier breach
Certain lots of product have the potential for a sterile barrier breach.
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Class II · 5 months ago
Philips Medical Systems Nederland B.v. Allura system recall: The deaeration hose in X-ray tube cooling units type CU3101
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially…
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Class II · 5 months ago
Philips Medical Systems Nederland B.v. Integris-Allura system recall: The deaeration hose in X-ray tube cooling units type CU3101
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially…
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Class II · 5 months ago
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall: Certain lots of product have the potential for a sterile barrier breach
Certain lots of product have the potential for a sterile barrier breach.
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Class II · 5 months ago
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers recall: Affected devices exhibited fractures at the distal shaft tip without complete
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
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Class II · 5 months ago
C.R. Bard Inc Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 recall: Due to stain present on the surface of affected foley catheters
Due to stain present on the surface of affected foley catheters.
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Class II · 5 months ago
Novapproach Spine, LLC OneLIF Interbody Cage : 010-107-1007/Small 7 Degree 10mm X 7mm recall: Intervertebral body fusion system straight inserter failed to properly attach
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage…
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Class II · 5 months ago
Philips Azurion systems not configured with an optional auxiliary pan recall: Potential safety issue with Philips Azurion systems
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the…