The Recall Desk
HighFDA (Devices)·Z-2638-2023·Announced 2023-10-04

3M Attest Biological Indicators Recalled for Defective Caps

3M is recalling specific lots of Attest biological indicators used in steam sterilization monitoring. Certain lots have caps that may melt, deform, or crack at sterilization temperatures of 132°C and 135°C, potentially compromising sterilization process verification.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The defective caps compromise the ability to reliably monitor sterilization processes, creating a risk-of-harm scenario where sterilization verification could fail. This meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

3M is recalling certain lots of its Attest biological indicator products used to monitor steam sterilization processes. The affected devices are: Attest Super Rapid Readout Biological Indicators (model 1492V), Attest Super Rapid 5 Steam-Plus Challenge (models 41482V and 41482VF), and Attest Super Rapid Readout Steam Challenge Pack (model 1496V). These devices are widely used in healthcare facilities and other settings to verify that sterilization equipment is functioning properly.

The recalled lots may contain defective caps that melt, deform, and/or crack when exposed to steam sterilization temperatures of 132°C and 135°C. If the cap fails, the biological indicator's integrity is compromised and it may not reliably indicate whether sterilization was successful.

A total of 33,504 devices have been distributed worldwide, including throughout the United States and to Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, and Taiwan. The affected lot codes are 33P4NJ (expiration 01/01/2025) and 33P56T (expiration 01/02/2025). Facilities using these indicators should discontinue use of the affected lots and contact 3M for replacement options.

The recalled product

Product
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Manufacturer
3M Company - Health Care Business
Category
Medical Device — Sterilization Monitoring
Hazard
  • cap-failure
  • device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category