3M Attest Steam Chemical Integrators Recalled for Ink Leakage Risk
3M is recalling 2.2 million Attest Steam Chemical Integrators (REF 1243B) due to an increased potential for ink leakage during sterilization cycles. No injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported injuries, illnesses, or deaths. The hazard is an increased potential for ink leakage—a precautionary defect with theoretical risk of sterilization verification failure, but no reported incidents.
Plain-English summary
3M Company is recalling approximately 2.2 million Attest Steam Chemical Integrators (REF 1243B) manufactured between November 6, 2022 and January 17, 2023. These devices are used to verify that sterilization cycles reach required temperatures and conditions in medical and laboratory settings.
The recalled integrators have an increased potential to leak ink during sterilization cycles. Ink leakage could affect the devices' ability to accurately indicate sterilization completion and may introduce contamination into the sterilization chamber.
The affected devices were distributed worldwide, including throughout the United States and to 29 foreign countries. Customers who have these lot numbers (EG112025 and ET012026) in their inventory should stop using them and contact 3M for instructions on replacement or proper return.
No injuries or illnesses have been reported to date. Healthcare facilities and laboratories using these integrators should verify their lot numbers against the recall information and follow 3M's guidance for obtaining replacement devices.
The recalled product
- Product
- 3M Attest Steam Chemical Integrators, REF 1243B
- Manufacturer
- 3M Company - Health Care Business
- Hazard
- ink-leakage
- product-defect
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 (4)
- UDI/DI: Pouch: 30707387785742
- (Shipper: 50707387785746)
- Lot Numbers: EG112025
- ET012026
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27