Bausch & Lomb Inc: Medical Device Recall in 2018 - (Recall #: Z-3268-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.

Product Classification:

Class II

Date Initiated: August 8, 2018

Date Posted: October 3, 2018

Recall Number: Z-3268-2018

Event ID: 80837

Reason for Recall:

The back cap separates from the body of the vitrectomy cutter.

Status: Terminated

Product Quantity: 103.33 cases

Code Information:

Lot numbers V9300, exp. 10/17/2018; V9807, exp. 1/7/2019; W0019, exp. 2/5/2019; and W1468, exp. 8/26/2019, UDI 00757770058907.

Distribution Pattern:

Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated