Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
3,717 recalls on file, issued by the FDA.
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Class II · 11 days ago
AVID Medical, Inc. Plastics Tray 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. Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 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. Heart Prep Tray 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. Pack Open Heart CFH 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
LeMaitre Vascular, Inc. TufTex¿ Over-the-Wire Embolectomy Catheter recall: Devices failed in process testing related to the amount of pull force it
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
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Class III · 11 days ago
Mindray DS USA, Inc. T1 Patient Monitor. Operator's Manual: T1 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
DRG International, Inc. Sperm Ab ELISA recall: Potential for false negative patient results
Potential for false negative patient results.
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Class II · 11 days ago
Intellijoint recall: A navigation system used to aid in selection and positioning of orthopedic
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch…
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Class II · 11 days ago
QUANTUM OPS Inc Brand Name: Adaptable Beach Chair Product Name: Beach Chair surgical recall: Due to a manufacturing issue (inadequate weld) for patient head positioning
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
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Class II · 11 days ago
AVID Medical, Inc. Laparoscopic Prostatectomy 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. BeneView Series. Operator's Manuals: T5 / T8 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 III · 11 days ago
Mindray DS USA, Inc. cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 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
Beckman Coulter Inc. DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE recall: Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of…
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Class II · 11 days ago
Canon Medical System, USA, INC. Alphenix INFX-8000C/B5 recall: Loosening of the bolts securing the longitudinal movement mechanism may cause
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient]…
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Class II · 11 days ago
GRI Medical & Electronic Technology Co., Ltd. Halyard Laparoscopy Comprehensive Pack recall: Laparoscopy packs labeled as "latex free" were found to contain a latex
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
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Class II · 11 days ago
AVID Medical, Inc. Endovascular 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 III · 11 days ago
Mindray DS USA, Inc. BeneVision Series Telemetry Monitor. Operator's Manuals 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. Davinci LAP/GYN 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
Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC Sediplast recall: During use of an affected tube, the operator may encounter increased
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause…
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Class II · 11 days ago
Beckman Coulter Inc. DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE recall: Beckman Coulter has identified a software issue affecting DxC 500i Clinical
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a…
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Class II · 11 days ago
Cardinal Health 200, LLC Presource Packs containing Medtronic Microstream Components recall: Kits contain Microstream components. Medtronic issued an update
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in…
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Class III · 11 days ago
Mindray DS USA, Inc. Panorama and Telemetry Monitoring System. Operator's Manuals 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. Major 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 III · 11 days ago
Medical Action Industries, Inc. 306 recall: An internal data-entry error caused kit lot 333606 to be labeled
An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.