IrriMAX Corporation: Medical Device Recall in 2019 - (Recall #: Z-0191-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Irrisept Wound Debridement and Cleansing System. 12 units per case.

Product Classification:

Class II

Date Initiated: August 16, 2019

Date Posted: October 30, 2019

Recall Number: Z-0191-2020

Event ID: 83599

Reason for Recall:

Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.

Status: Terminated

Product Quantity: 1,031 cases (12,372 units)

Code Information:

Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30

Distribution Pattern:

Nationwide distribution to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV.

Voluntary or Mandated:

Voluntary: Firm initiated