3M Company - Health Care Business: Medical Device Recall in 2023 - (Recall #: Z-1610-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.
Product Description:

3M Attest Steam Chemical Integrators, REF 1243B

Product Classification:

Class II

Date Initiated: April 6, 2023
Date Posted: May 24, 2023
Recall Number: Z-1610-2023
Event ID: 92041
Reason for Recall:

3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

Status: Ongoing
Product Quantity: 2,235,000 units
Code Information:

UDI/DI: Pouch: 30707387785742, (Shipper: 50707387785746), Lot Numbers: EG112025, ET012026

Distribution Pattern:

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Australia, Bolivia, Brazil, Canada, Colombia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Poland, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated