Food, drugs, devices › 3M Company - Health Care Business
Device recall: 3M Attest Steam Chemical Integrators, REF 1243A
FDA enforcement event 92041 is a device recall by 3M Company - Health Care Business of Saint Paul, MN, initiated 6 Apr 2023 and classified Class II, with 2 product records.
FDA defines Class II as 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. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. 3M Company - Health Care Business has 29 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
3M Company - Health Care Business, Saint Paul, MN.
Reason for recall
"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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1609-2023 | 3M Attest Steam Chemical Integrators, REF 1243A | 16,229,000 units | Class II | Ongoing | 24 May 2023 |
| Z-1610-2023 | 3M Attest Steam Chemical Integrators, REF 1243B | 2,235,000 units | Class II | Ongoing | 24 May 2023 |
Context
Other enforcement events for 3M Company - Health Care Business
All 29 events for 3M Company - Health Care Business
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Australia, Bolivia, Brazil, Canada, Colombia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.