Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 11 days ago
AVID Medical, Inc. GYN Laparoscopy/Laparotomy recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
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Class III · 11 days ago
Mindray DS USA, Inc. BeneVision N1 and N-Series Patient Monitor. Patient Monitor recall: Certain monitor operator's manuals contain descriptions
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm…
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Class II · 11 days ago
AVID Medical, Inc. ABD Hysterectomy recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
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Class II · 11 days ago
AVID Medical, Inc. GYN Laparoscopy Pack recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
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Class II · 11 days ago
Medline Industries, LP Rollator, Bariatric, Basic Steel, Burgundy recall: The front fork stem bolt/wheel assembly may disconnect from the rollator
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from…
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Class II · 11 days ago
Steris Corporation Verify Biological Steam Test Pack Model/ recall: Geobacillus stearothermophilus spore population in affected products may fall
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam…
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Class II · 11 days ago
AVID Medical, Inc. Davinci Trucustom Bundle recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
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Class III · 11 days ago
Mindray DS USA, Inc. ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM recall: Certain monitor operator's manuals contain descriptions
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm…
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Class II · 11 days ago
AVID Medical, Inc. Urology Major recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
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Class II · 11 days ago
Steris Corporation HexaVue Focus Integration System, a single recall: A software issue may result in unintended mismatch of patient information
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on…
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Class II · 11 days ago
AVID Medical, Inc. Craniotomy Pack recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
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Class II · 11 days ago
Onkos Surgical Inc. My3D recall: Personalized pelvic implants inadvertently mixed up and distributed
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
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Class II · 11 days ago
AVID Medical, Inc. Adult Heart Tray Shands Jacks recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
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Class II · 11 days ago
Steris Corporation Verify Biological/Integrator Challenge Pack Model/ recall: Geobacillus stearothermophilus spore population in affected products may fall
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam…
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Class II · 11 days ago
AVID Medical, Inc. Robotic Prostatectomy Pack recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
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Class II · 11 days ago
Steris Corporation Verify Dual Species Self-Contained Biological Indicator Model/ recall: Geobacillus stearothermophilus spore population in affected products may fall
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam…
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Class II · 11 days ago
Limitless Cryo Spa LLC Glypto Device, Glypto Cryo Machine recall: Lack of 510(k) clearance
Lack of 510(k) clearance.
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Class II · 11 days ago
Steris Corporation Verify Dual Species Self-Contained Biological Indicator Model/ recall: Geobacillus stearothermophilus spore population in affected products may fall
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam…
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Class II · 11 days ago
Steris Corporation Verify Biological/Integrator Challenge Pack Model/ recall: Geobacillus stearothermophilus spore population in affected products may fall
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam…
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Class II · 11 days ago
Safeguard US Operating LLC Battle Bandage, REF: 32-700 recall: Compression bandage may be degraded, which may cause unwanted foreign
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration…
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Class II · 11 days ago
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/ recall: Due to a cybersecurity issue associate with a NULL Pointer Dereferences
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the…
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Class II · 11 days ago
Onkos Surgical Inc. My3D recall: Personalized pelvic implants inadvertently mixed up and distributed
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
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Class II · 11 days ago
Medline Industries, LP Rollator, Bariatric, Basic Steel, Blue recall: The front fork stem bolt/wheel assembly may disconnect from the rollator
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from…
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Class II · 11 days ago
Philips Medical Systems Spectral CT and Spectral CT 7500 RT recall: Software issues may affect the safety and performance of Spectral CT
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or…