International Life Sciences: Medical Device Recall in 2026 - (Recall #: Z-1555-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Artelon FlexBand Plus Ref: 41054 & 41057

Product Classification:

Class II

Date Initiated: February 6, 2026

Date Posted: March 18, 2026

Recall Number: Z-1555-2026

Event ID: 98399

Reason for Recall:

Augmentation devices failed bacterial endotoxin testing.

Status: Ongoing

Product Quantity: N/A

Code Information:

REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033

Distribution Pattern:

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.

Voluntary or Mandated:

Voluntary: Firm initiated