3M Attest Super Rapid Readout Biological Indicators: Cap May Melt During Sterilization
3M recalls specific lots of Attest Super Rapid Readout Biological Indicators that may have a cap melting during steam sterilization cycles, risking improper sterilization of medical equipment.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
3M is recalling specific lots of Attest Super Rapid Readout Biological Indicators that may melt during steam sterilization cycles. This could lead to improper sterilization of medical equipment, potentially causing infections. Read more at govinfonow.com/recall/57450-3m-attest-super-rapid-readout-biological-indicators-cap-may-melt.
Source Summary by GovInfoNow · govinfonow.com/recall/57450-3m-attest-super-rapid-readout-biological-indicators-cap-may-melt · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2637-2023
Cite this page
“3M Attest Super Rapid Readout Biological Indicators: Cap May Melt During Sterilization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57450-3m-attest-super-rapid-readout-biological-indicators-cap-may-melt. Based on FDA recall #Z-2637-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2637-2023%22&limit=1).
Why it’s dangerous
The biological indicators' caps may melt, deform, or crack after a steam sterilization cycle at 132°C or 135°C. This can cause the indicators to fail, meaning medical equipment might not be properly sterilized.
Who’s affected
Healthcare facilities using these specific lots for sterilization cycles are affected. Staff handling these indicators during steam sterilization are at risk of improper sterilization.
How to tell if you have this one
Check for lot codes 33P3X3 (expires 12/29/2024) or 33P4NH (expires 01/01/2025) on the packaging. These indicators are used for steam sterilization cycles in healthcare settings.
- Brand
3M- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2637-2023 | 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles; UDI/DI: 50707387762969 (shipper), 30707387762965 (carton); Lot codes: 33P3X3, exp. 12/29/2024; 33P4NH, exp. 01/01/2025 | 79500 devices |
| Z-2638-2023 | 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes; UDI/DI: 50707387762983( (shipper); Lot codes: 33P4NJ, exp. 01/01/2025; 33P56T, exp. 01/02/2025 | 33504 devices |
| Z-2639-2023 | 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes; UDI/DI: 50707387787276( (shipper); Lot Codes: 33P3EF, exp. 12/27/2024; 33P4ND, exp. 01/01/2025; 33P4NR, exp. 01/01/2025; 33P5CA, exp. 01/03/2025; 33P5XT, exp. 01/06/2025 | 172,464 devices |
| Z-2640-2023 | 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes; UDI/DI: 50707387787283( (shipper); Lot Codes: 41482VF, exp. 33P4ND; 33P4YN, exp. 01/02/2025 | 77,280 devices |
What to do — step by step
Check Lot Codes
Look for lot codes 33P3X3 (expires 12/29/2024) or 33P4NH (expires 01/01/2025) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 43 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these indicators immediately?
No, but you should check the lot codes and follow the action steps to ensure proper sterilization.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2637-2023 (August 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2637-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.