The Recall Desk
ModerateFDA (Devices)·Z-1610-2023·Announced 2023-05-24

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
Category
Medical Device — Sterilization Verification
Hazard
Affected units
2,235,000

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 (4)

  • UDI/DI: Pouch: 30707387785742
  • (Shipper: 50707387785746)
  • Lot Numbers: EG112025
  • 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 →

Related recalls

Same manufacturer · 3M Company - Health Care Business

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Same hazard · ink leakage

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