Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 7 months ago
Covidien LLC HealthCast "Vital Sync" Remote Patient Monitoring System which consists recall: Due to complaints and investigations stating that alarms from the primary
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on…
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Class III · 7 months ago
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 recall: The device does not bear a unique device identifier
The device does not bear a unique device identifier.
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 7 months ago
International Life Sciences Artelon FlexBand Plus Ref: 41054 & 41057 recall: Augmentation devices failed bacterial endotoxin testing
Augmentation devices failed bacterial endotoxin testing.
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Class II · 7 months ago
KOB GmbH Medline Unna-Z Stretch Zinc Paste Bandage recall: Due to labeling error. Incomplete ingredients listed. Labeling did
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
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Class II · 7 months ago
International Life Sciences Artelon Flexband Twist .12 Ref: TW012 3.85x17mm HEX recall: Augmentation devices failed bacterial endotoxin testing
Augmentation devices failed bacterial endotoxin testing.
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 PAK recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 PAK recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 PAK recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 7 months ago
Medartis AG Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7 recall: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
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Class II · 7 months ago
Physio-Control, Inc. Physio Control Infant/Child Reduced Energy Defibrillator recall: Due to pediatric defibrillator electrode delamination
Due to pediatric defibrillator electrode delamination
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Class II · 7 months ago
Beckman Coulter Mishima K.K. DxC 700 AU, REF: B86444, B86446 recall: A delay in results may occur. When clinical chemistry analyzer calibration
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open…
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 PAK recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class III · 7 months ago
Penner Pacific Bathing Spa, Model Numbers 360030-1C recall: The device does not bear a unique device identifier
The device does not bear a unique device identifier.
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Class III · 7 months ago
Penner Pacific Bathing Spa, Model Numbers 360020-1EP recall: The device does not bear a unique device identifier
The device does not bear a unique device identifier.
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Class II · 7 months ago
Exactech, Inc. Brand Name: Equinoxe Ergo Product Name: Ergo Modular recall: Impactor handle may be missing cross-pin
Impactor handle may be missing cross-pin
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Class II · 7 months ago
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage recall: The instructions for use (IFUs) on specified Cardinal Health Chest Drainage
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended…
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 PAK recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
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Class II · 7 months ago
Waldemar Link GmbH & Co. KG Endo-Model Replacement Plateau recall: The potential for an implant with a plateau screw where the bushing
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…