The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1609-2023·Announced 2023-05-24

3M Attest Steam Chemical Integrators recalled for potential ink leakage during sterilization

3M is recalling 3M Attest Steam Chemical Integrators manufactured November 2022–January 2023 due to increased potential for ink leakage during sterilization cycles. Approximately 16.2 million units were distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall of a medical device critical to sterilization validation. Although no illnesses or injuries have been reported, the potential for ink leakage in a risk-of-harm product meets the criterion for score 3 per the rubric.

Plain-English summary

3M Company is recalling 3M Attest Steam Chemical Integrators, model REF 1243A, manufactured between November 6, 2022 and January 17, 2023. These devices have an increased potential to leak ink during sterilization cycles.

Approximately 16.2 million units are affected. The products were distributed worldwide, including throughout the United States and internationally in 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.

Affected lot numbers are: EP112025, EX112025, FE112025, EE122025, EM122025, EV122025, FD122025, EC012026, EM012026, and ET012026.

The recalled product

Product
3M Attest Steam Chemical Integrators, REF 1243A
Manufacturer
3M Company - Health Care Business
Category
Medical Device — Sterilization / Quality Control
Hazard
Affected units
16,229,000

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 (12)

  • UDI/DI: Pouch: 30707387785735
  • (Shipper: 50707387785739)
  • Lot Numbers: EP112025
  • EX112025
  • FE112025
  • EE122025
  • EM122025
  • EV122025
  • FD122025
  • EC012026
  • EM012026
  • ET012026

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by 3M Company - Health Care Business under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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