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
Orthalign, Inc Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 recall: Drill plates manufactured out of specification can result in a bone cut
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
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Class II · 7 months ago
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm recall: Drainable large pouch may leak due to manufacturing issue
Drainable large pouch may leak due to manufacturing issue.
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Class II · 7 months ago
GE Medical Systems, LLC Centricity Universal Viewer Software Versions 7.0 through 7.0 recall: There is a potential cybersecurity vulnerability affecting certain versions
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on…
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Class II · 7 months ago
Baxter Healthcare Corporation Brand Name: Welch Allyn recall: Display screen may unintentionally flicker due to a software issue. Exposure
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in…
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Class II · 7 months ago
Abbott Diagnostics Scarborough, Inc. Product Name: ID NOW" Influenza A & B 2 Model/ recall: It was confirmed that the impacted lot has a higher occurrence of invalid
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
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Class II · 7 months ago
GE Medical Systems, LLC Centricity Universal Viewer Software Versions 5.0 SP6 through recall: There is a potential cybersecurity vulnerability affecting certain versions
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on…
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Class II · 7 months ago
Hologic, Inc. Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/ recall: Due to product exhibiting potential to generate either invalid or false
Due to product exhibiting potential to generate either invalid or false negative results.
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Class II · 7 months ago
Stryker Medical Division of Stryker Corporation Cub Pediatric Crib, Model FL19H recall: Cribs sold in the USA are missing two access door warning labels
Cribs sold in the USA are missing two access door warning labels.
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Class II · 7 months ago
LeMaitre Vascular, Inc. Artegraft Vascular Graft recall: Labeling mix-up resulting in the incorrect lot outer packaging of product
Labeling mix-up resulting in the incorrect lot outer packaging of product.
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Class II · 7 months ago
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm recall: Drainable large pouch may leak due to manufacturing issue
Drainable large pouch may leak due to manufacturing issue.
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Class II · 7 months ago
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm recall: Drainable large pouch may leak due to manufacturing issue
Drainable large pouch may leak due to manufacturing issue.
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Class II · 7 months ago
Diagnostica Stago, Inc. Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di recall: After receiving customer complaints, investigations confirmed the presence
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire…
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Class II · 7 months ago
GE Medical Systems, LLC Centricity Universal Viewer Software Versions 6.0 through 6.0 recall: There is a potential cybersecurity vulnerability affecting certain versions
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on…
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Class II · 7 months ago
Elekta, Inc. Brand Name: Leksell Gamma Knife recall: Due to adapter not being properly aligned or locked in place
Due to adapter not being properly aligned or locked in place.
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Class II · 7 months ago
Howmedica Osteonics Corp. MICS3 Angled Sagittal Saw Attachment recall: A potential issue was identified with the torque strength on the external
A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which…
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Class III · 7 months ago
Datascope Corp. Battery Charging Station recall: The Battery Charging Station is an optional dual-bay charger used to charge
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used…
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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
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
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 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
Boston Scientific Corporation EndoVive Safety PEG Kit recall: Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result…
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Class II · 7 months ago
Altruan GmbH Wondfo Streptococcal A At-Home Self-Test. At-home test for group recall: Product not cleared by the FDA
Product not cleared by the FDA.
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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 III · 7 months ago
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 recall: The device does not bear a unique device identifier
The device does not bear a unique device identifier.