Z-1609-2023Class II

3M Attest Steam Chemical Integrators, REF 1243A

Name: Z-1609-2023 3M Attest Steam Chemical Integrators, REF 1243A
Creator: 3M Company - Health Care Business
Published: 2023-04-06
License: https://open.fda.gov/license/

3M Company / initiated 2023-04-06 / Open, Classified / root cause: manufacturing process

FDA source

3M Company - Health Care Business began a recall of 3M Attest Steam Chemical Integrators, REF 1243A on 2023-04-06. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1609-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-06
Posted: 2023-05-18
Recalling firm: 3M Company
Product: 3M Attest Steam Chemical Integrators, REF 1243A
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 16,229,000 units
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 codes and lots: UDI/DI: Pouch: 30707387785735, (Shipper: 50707387785739), Lot Numbers: EP112025, EX112025, FE112025, EE122025, EM122025, EV122025, FD122025, EC012026, EM012026, ET012026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1609-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1609-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-18
Z-1610-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-18

Product code JOJ

K220942Class II3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company / cleared 2022-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)