Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 6 months ago
Medline Convenience Kits: 1) Angio Procedure Pack 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 · 6 months ago
Boston Scientific Corporation Lux-Dx II, Arrythmia detector and alarm, Model M302 recall: For some patients upgraded from a LUX-Dx M301 device to a new Model M302
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both…
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Class II · 6 months ago
Medline Convenience Kits: 1) Arthroscopy CDS 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 · 6 months ago
Medline Convenience Kits: 1) Baptist Floyd Endo GI KIT 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 · 6 months ago
BioFire Joint Infection Panel REF: RFIT-ASY-0138, 30 test Kit recall: Contamination to in-vitro diagnostic test may result in false positives
Contamination to in-vitro diagnostic test may result in false positives.
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Class II · 6 months ago
Medline Convenience Kits: 1) Picc Line Tray 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 · 6 months ago
Medline Convenience Kits: 1) Hysteroscopy 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 · 6 months ago
Centinel Spine, Inc. Prodisc C SK U.S. Implant Extra Large 6MM recall: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm…
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Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Major 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 I · 6 months ago
AVID Medical, Inc. Halyard Cardiac Cath Pack SAN23Cardq kit recall: Potential risk for Medline syringe rotating adaptor unwinding during use
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between…
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Class II · 6 months ago
Medline Industries, LP See full list in RES, exceeds character limit 1) GYN 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 · 6 months ago
Medline Convenience Kits: 1) KIT STC Tracheostomy 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 I · 6 months ago
Ventec Life Systems, Inc. VOCSN V+Pro package, REF: PRT-01198-000 recall: Respiratory system intended to provide continuous/intermittent ventilator
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure…
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Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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Class II · 6 months ago
DFI Co., Ltd. Uric Acid in vitro diagnostic test REF: 31H0P recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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Class II · 6 months ago
Medline Convenience Kits: 1) Angio Procedure Pack 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 · 6 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 · 6 months ago
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL recall: Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
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Class I · 6 months ago
American Contract Systems Inc Convenience kits containing Medline Namic Angiographic recall: Impacted kits contain syringes recalled by Medline Industries. Syringe
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection…
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Class II · 6 months ago
Medline Convenience Kits: 1) DYNDA3003 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 · 6 months ago
Medline Convenience Kits: 1) SCC RF Pain Mgmt 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 · 6 months ago
Medline Convenience Kits: 1) Basic Nerve Block Tray W/Linen 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 · 6 months ago
Physio-Control, Inc. Lifepak 15, REF: 99577-000025, 99577-000047 recall: Some defibrillators serviced between July 2023 through November 2025
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure…