CLASS II ONGOING Device recall · Reported 4 Oct 2023 · FDA Enforcement Report

3M Attest Super Rapid Readout Steam Challenge Pack recalled

3M Company - Health Care Business is recalling 3M Attest Super Rapid Readout Steam Challenge Pack, distributed nationwide in the US. The recall was initiated on 22 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI: 50707387762983( (shipper); Lot codes: 33P4NJ, exp. 01/01/2025; 33P56T, exp. 01/02/2025

Quantity recalled33504 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2638-2023
FDA event ID: 92915
Recalling firm: 3M Company - Health Care Business, Saint Paul, MN
Classification: Class II
Status: Ongoing
Recall initiated: 22 Aug 2023
FDA classified: 26 Sep 2023
Reported: 4 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Sterility
Device type: Patient Monitors

Timeline

22 Aug 2023	Recall initiated by company
26 Sep 2023	Classified by FDA	+35 days
4 Oct 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 132¿C and 135¿C.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.

Nationwide

Questions about this recall

Is 3M Attest Super Rapid Readout Steam Challenge Pack recalled?

Yes. 3M Company - Health Care Business recalled 3M Attest Super Rapid Readout Steam Challenge Pack on 22 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-2638-2023.

Why was it recalled?

Which lots are affected?

UDI/DI: 50707387762983( (shipper); Lot codes: 33P4NJ, exp. 01/01/2025; 33P56T, exp. 01/02/2025

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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