3M Attest recallZ-1609-2023 · 3M Company - Health Care Business · initiated Apr 6, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from 3M Company - Health Care Business or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
3M issued an URGENT: Voluntary Product Recall to its consignees beginning 04/06/2023 via email or USPS certified mail. The notice explained the issue, hazard, and requested that the use of the affected product cease, identify any in stock product and dispose of it. The firm will replace the product. To request product replacement for affected lots disposed, contact 3M Health Care Customer Helpline at 1-800-228-3957, option #7 or by email to [email protected]. Please note, replacement product can only be provided following 3M receipt of the completed form. If you have questions, please the 3M Health Care Customer Helpline at 1-800-228-3957, option #7.
Recall details
- Recall number
- Z-1609-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 6, 2023
- Posted by the FDA
- May 18, 2023
- Recalling firm
- 3M Company - Health Care Business
- Quantity
- 16,229,000 units
- Product code
- JOJ
- FDA submissions
- K220942
- Distribution
- 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.
Product description
3M Attest Steam Chemical Integrators, REF 1243A
Code information (models, lots, serial numbers)
UDI/DI: Pouch: 30707387785735, (Shipper: 50707387785739), Lot Numbers: EP112025, EX112025, FE112025, EE122025, EM122025, EV122025, FD122025, EC012026, EM012026, ET012026
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 3M™ Attest™ 1243A3m Company · Indicator, physical/chemical sterilization process1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92041).
- Z-1610-2023 · Open, Classified3M Attest Steam Chemical Integrators, REF 1243B
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page