openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 7
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
These labels are deterministic app interpretations, not FDA categories.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Code information
GTIN: 08714729978572 Lot Number: 30554442 Exp. Date: 16-Nov-2025
Distribution pattern
Worldwide distribution - US Nationwide and the country of Canada.
device · product 2 of 7
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
These labels are deterministic app interpretations, not FDA categories.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Code information
GTIN: 08714729978619 Lot Number: 30389365, 30389368, 30389369, 30429826, 30479399, 30479580, 30479582, 30554453 Exp. Date: 20-Oct-2025 to 3-Nov-2025
Distribution pattern
Worldwide distribution - US Nationwide and the country of Canada.
device · product 3 of 7
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
These labels are deterministic app interpretations, not FDA categories.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Worldwide distribution - US Nationwide and the country of Canada.
device · product 4 of 7
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
These labels are deterministic app interpretations, not FDA categories.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Code information
GTIN: 08714729978671 Lot Numbers: 30389427, 30389429, 30389431, 30521475, 30521476, 30521477 Exp. Date: 20-Oct-2025 to 10-Nov-2025
Distribution pattern
Worldwide distribution - US Nationwide and the country of Canada.
device · product 5 of 7
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
These labels are deterministic app interpretations, not FDA categories.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Code information
GTIN: 08714729978725 Lot Numbers: 30521480, 30521485 ,30521486 Exp. Date: 20-OCT-2024 to 10-Nov-2025
Distribution pattern
Worldwide distribution - US Nationwide and the country of Canada.
device · product 6 of 7
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
These labels are deterministic app interpretations, not FDA categories.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Code information
GTIN: 08714729978718 Lot Numbers: 30261914, 30389513, 30429863, 30429864, 30479612 Exp. Date: 02-Oct-2025 to 3-Nov-2025
Distribution pattern
Worldwide distribution - US Nationwide and the country of Canada.
device · product 7 of 7
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
These labels are deterministic app interpretations, not FDA categories.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
Code information
GTIN: 08714729978763 Lot Numbers: 30389516, 30389520, 30389525, 30429871, 30479615 Exp. Date: 20-Oct-2025 to 3-Nov-2025
Distribution pattern
Worldwide distribution - US Nationwide and the country of Canada.
