3M Company - Health Care Business: Medical Device Recall in 2023 - (Recall #: Z-2638-2023)

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 Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes

Product Classification:

Class II

Date Initiated: August 22, 2023

Date Posted: October 4, 2023

Recall Number: Z-2638-2023

Event ID: 92915

Reason for Recall:

Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C.

Status: Ongoing

Product Quantity: 33504 devices

Code Information:

UDI/DI: 50707387762983( (shipper); Lot codes: 33P4NJ, exp. 01/01/2025; 33P56T, exp. 01/02/2025

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated