Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIUltrasonic Bronchoscope BF-UC160F-OL8
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-Q180-AC
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-Q180
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchofiberscope BF-P60
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchofiberscope BF-P40
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-P240
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-P180
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-P160
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-MP60
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-MP160F
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchofibercope BF-6C240
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchofiberscope BF-40
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-3C40
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-3C160
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-240
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope F-1TQ180
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-1T60
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovidescope BF-1T240
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-1T180
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchofiberscope F-1T160
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceOlympus Corporation of the AmericasClass IIBronchovideoscope BF-160
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- 2018-10-10FDA-DeviceRayner Intraocular Lenses LimitedClass IIC-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification
Firm become aware of reports of post-operative refractive errors following implantation of lenses.
- 2018-10-10FDA-DeviceStryker NeurovascularClass IIAXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
- 2018-10-10FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS Sodium Slides, Catalog # 837 9034
Potential for positively biased results
- 2018-10-10FDA-DeviceSmiths Medical ASD Inc.Class IIIsmiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- 2018-10-10FDA-DeviceSmiths Medical ASD Inc.Class IIIsmiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- 2018-10-10FDA-DeviceSmiths Medical ASD Inc.Class IIIsmiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- 2018-10-10FDA-DeviceSmiths Medical ASD Inc.Class IIIsmiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- 2018-10-10FDA-DeviceSmiths Medical ASD Inc.Class IIIsmiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- 2018-10-10FDA-DeviceCOVIDIEN LLCClass IIEEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
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