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
Medline Convenience Kits: 1) KIT Triple Lumen Insertion recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 8 months ago
Immunotech A.S. Estrone RIA, REF: DSL8700 recall: The affected Estrone RIA kit lots may rarely give falsely high patient
The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some…
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Class II · 8 months ago
Medline Convenience Kits: 1) KIT Surg ONC Excision Breast recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 8 months ago
Philips North America Llc Spectral CT 7500 on Rails recall: As part of the CT systems sub assembly, thirty-two (32) fasteners are used
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these…
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Class II · 8 months ago
Medline medical convenience kits packaged as: Mercy Circumcision Tray recall: Medline Industries, LP is issuing a recall for specific items and lots
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined…
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Class I · 8 months ago
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra recall: These lots of reprocessed catheters may contain small particles of residual
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory…
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Class II · 8 months ago
Medline medical convenience kits packaged as: Adult Cath Securement recall: Medline Industries, LP is issuing a recall for specific items and lots
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined…
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Class II · 8 months ago
Medline medical convenience kits packaged as: Blood Culture KIT NS recall: Medline Industries, LP is issuing a recall for specific items and lots
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined…
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Class I · 8 months ago
Medline Industries, LP Reprocessed Livewire Steerable Diagnostic Electrophysiology recall: These lots of reprocessed catheters may contain small particles of residual
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory…
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Class II · 8 months ago
Medline Industries, LP 1) Universal KIT, Kit SKU DT22010B recall: Medline Industries, LP is issuing a recall for specific items and lots
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined…
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Class II · 8 months ago
Medline medical convenience kits packaged as: 1) Cancer Service Port recall: Medline Industries, LP is issuing a recall for specific items and lots
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined…
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Class I · 8 months ago
Medline Industries, LP Reprocessed Biosense Webster Soundstar eco Diagnostic recall: These lots of reprocessed catheters may contain small particles of residual
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory…
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Class II · 8 months ago
Hologic, Inc Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy recall: Presence of particulates in affected devices that can be deposited
Presence of particulates in affected devices that can be deposited into breast tissue during use.
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Class II · 8 months ago
Medline medical convenience kits packaged as: Sterile Resuture Pack recall: Medline Industries, LP is issuing a recall for specific items and lots
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined…
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Class II · 8 months ago
Alphatec Spine, Inc. Atec Lateral Navigation Disc Prep Instruments LIF NAV recall: Due a design issue where the navigated array connection geometry is incorrect
Due a design issue where the navigated array connection geometry is incorrect.
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Class III · 8 months ago
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn recall: Retroactively reported; Labeling contains incorrect sizing guide for Cap
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
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Class II · 8 months ago
Medline Industries, LP Intubation Tray containing Suction Catheter Kits SKU Dynjaa245B recall: A smaller open suction catheter, the 8 Fr Suction Catheter
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use…
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Class III · 8 months ago
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn recall: Retroactively reported; Labeling contains incorrect sizing guide for Cap
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
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Class II · 8 months ago
Philips Medical Systems Nederland B.v. Azurion 5 M20 System Model Numbers: 722228 recall: Under certain conditions, the table may move unexpectedly when the Reset
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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Class II · 8 months ago
Elekta, Inc. Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment recall: Due to an error when defining a new stereotactic reference that users fail
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan…
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Class II · 8 months ago
Medline medical convenience kits packaged as: ) Lvad Dressing Change recall: Medline Industries, LP is issuing a recall for specific items and lots
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined…
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Class II · 8 months ago
Steris Corporation Barco MNA with the HexaVue IP Integration System, Model/ recall: This is a sub-recall of event RES 96885. The supplier identified that during
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter)…
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Class II · 8 months ago
Philips Medical Systems Nederland B.v. Azurion 7 B20 System Model Numbers: 722068 recall: Under certain conditions, the table may move unexpectedly when the Reset
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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Class II · 8 months ago
Medline medical convenience kits packaged as: Anesthesia Artline Pack recall: Medline Industries, LP is issuing a recall for specific items and lots
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined…