Olympus Corporation of the Americas: Medical Device Recall in 2022 - (Recall #: Z-1296-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use Fiber Model # Labeled TFL-FBX200S (Carton) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX365S (Pouch) - 200 Micron Single Use Fiber

Product Classification:

Class II

Date Initiated: May 26, 2022

Date Posted: July 6, 2022

Recall Number: Z-1296-2022

Event ID: 90338

Reason for Recall:

Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.

Status: Terminated

Product Quantity: 190 cartons (950 pieces total)

Code Information:

UDI-DI Lot Model# Labeled 00821925043923 KR149856 TFL-FBX150BS (Carton) 00821925043923 KR149856 TFL-FBX200S (Pouch) 00821925043985 KR195775 TFL-FBX200BS (Carton) 00821925044043 KR197789 TFL-FBX550S (Carton) 00821925043930 KR206254 TFL-FBX200S (Carton) 00821925043930 KR206254 TFL-FBX365S (Pouch)

Distribution Pattern:

Nationwide distribution in the US. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated