Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 2 months ago
Brand Name: Kico Knee Innovation Product Name: Arvis Surgical recall: Due to an internal sensor issue, image displayed with eyepiece may appear
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
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Class II · 2 months ago
Tobii Dynavox Llc TD Navio Midi Speech Generating Device Model/ recall: Under certain conditions, the battery mounting tabs may become damaged
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading…
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Class II · 2 months ago
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System recall: Due to a firmware defect, the portable organ transfer device datalogger
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed…
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Class II · 2 months ago
Siemens Healthcare Diagnostics, Inc. Syva EMIT 2000 Quinidine Assay REF: 4Q019UL recall: Due to unacceptable precision performance exhibited in certain lots
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated…
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Class II · 2 months ago
restor3d Inc. Brand Name: Veritas Standard Reverse Total Shoulder Product Name recall: Due to incorrect machining of peripheral screw hole resulting in potential
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
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Class II · 2 months ago
Gentherm Medical, LLC Blanketrol II Model 222S recall: Overheating of the 115V CPU board may cause the device to shut down
Overheating of the 115V CPU board may cause the device to shut down.
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Class II · 2 months ago
Siemens Healthcare Diagnostics, Inc. Beckman Coulter recall: Due to unacceptable precision performance exhibited in certain lots
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated…
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Class II · 2 months ago
American Contract Systems medical procedure kits and trays labeled recall: The recall notice was initiated due to a Medicom Urgent Medical Device
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges…
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Class II · 2 months ago
Intersurgical Inc One-Piece Guedel Airway, size 00, ISO 5.0 recall: Devices could potentially be occluded or partially occluded
Devices could potentially be occluded or partially occluded.
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Class II · 2 months ago
AVID Medical, Inc. Halyard Lavh Pack, Model/ recall: The kit component was subjected to EO sterilization
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a…
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Class II · 2 months ago
Boston Scientific Corporation OverStitch Suture Cinch recall: Device may fail to deploy the cinch implant and/or fail to cut the suture
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
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Class II · 2 months ago
Intersurgical Inc One-Piece Guedel Airway, size 000, ISO 3.5 recall: Devices could potentially be occluded or partially occluded
Devices could potentially be occluded or partially occluded.
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Class II · 2 months ago
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067 recall: Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural…
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Class II · 2 months ago
Biofire Respiratory Panel 2.1 REF 423742 UDI code: 00815381020529 recall: Due to increase in false negative results
Due to increase in false negative results
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Class II · 2 months ago
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light recall: There is a potential for vaginal speculums to contain a burr on the proximal
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions…
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Class II · 2 months ago
Covidien, LP Dermalon 88861757-31 Dermalon* 4-0 BLU 75CM C13 88861757-31 88861799-31 recall: Product may contain a perforation or tear in the sterile barrier packaging
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which…
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Class II · 2 months ago
Cardinal Health Presource Kits: 1) Basic Pack recall: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
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Class II · 2 months ago
Covidien, LP Surgipro SP-623 Surgipro* 2-0 BLU 75CM SC2 X36 SP-623 recall: Product may contain a perforation or tear in the sterile barrier packaging
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which…
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Class II · 2 months ago
Bioporto Diagnostics A/S ProNephro AKI Reagent Kit . IVD Acute Kidney Injury Test recall: The use of a non-validated rework process for assay reagents which could lead
The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment…
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Class II · 2 months ago
Straumann USA LLC GM Helix Implant, Endosseous Dental Implant Article No. 109.984 recall: There may be a mismatch between the implant contained inside the packaging
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the…
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Class II · 2 months ago
Cardinal Health Presource Kits: 1) Septo Rhino Pack recall: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
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Class II · 2 months ago
Waldemar Link GmbH & Co. KG Endo-Model, Replacement Set, Tibial Plateau, right/left, L recall: The affected Endo-Model replacement set for a Rotating Hinge tibial plateau
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could…
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Class II · 2 months ago
Bd Switzerland Sarl 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code recall: Products may not have received adequate sterilization processing
Products may not have received adequate sterilization processing.
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Class II · 2 months ago
Spacelabs Healthcare, Inc. Brand Name: Xhibit Product Name: Xhibit Central Station recall: Due to off-the-shelf display port component that has audio/video failures
Due to off-the-shelf display port component that has audio/video failures