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.
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: 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
- Hazard
- ink-leakage
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.
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