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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92041

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 06, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
3M Company - Health Care Business

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

3M Attest Steam Chemical Integrators, REF 1243A

Z-1609-2023
Recall number
Z-1609-2023
Initiated
April 06, 2023
Classification
Class II
Status
Ongoing
Quantity
16,229,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI: Pouch: 30707387785735, (Shipper: 50707387785739), Lot Numbers: EP112025, EX112025, FE112025, EE122025, EM122025, EV122025, FD122025, EC012026, EM012026, ET012026

Distribution pattern

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.

device · product 2 of 2

3M Attest Steam Chemical Integrators, REF 1243B

Z-1610-2023
Recall number
Z-1610-2023
Initiated
April 06, 2023
Classification
Class II
Status
Ongoing
Quantity
2,235,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI: Pouch: 30707387785742, (Shipper: 50707387785746), Lot Numbers: EG112025, ET012026

Distribution pattern

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.