Z-2638-2023Class II

3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air...

Name: Z-2638-2023 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air...
Creator: 3M Company - Health Care Business
Published: 2023-08-22
License: https://open.fda.gov/license/

3M Company / initiated 2023-08-22 / Open, Classified / root cause: manufacturing process

FDA source

3M Company - Health Care Business began a recall of 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes on 2023-08-22. FDA classified it as Class II and gives the reason as "Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain...". 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-2638-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-22
Posted: 2023-09-26
Recalling firm: 3M Company
Product: 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 3M issued an Urgent product recall notice to its consignees on 08/24/2023 by email and US mail. The notice explained the problem with the product and requested the following: Discontinue distribution of the product and dispose of the product. Distributors were directed to notify their customers. The firm is offering replacement with the return of the completed response form.
Quantity in commerce: 33504 devices
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.
Product codes and lots: UDI/DI: 50707387762983( (shipper); Lot codes: 33P4NJ, exp. 01/01/2025; 33P56T, exp. 01/02/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2638-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2637-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-26
Z-2638-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-26
Z-2639-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-26
Z-2640-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-26

Product code FRC

K173519Class II3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader3M Company / cleared 2018-04-23

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)