3M Attest Sterilization Indicator Caps May Melt or Crack
3M is recalling 172,464 units of Attest biological indicators used to validate steam sterilization because caps may melt, deform, or crack during sterilization at 132°C and 135°C.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The cap defects represent a risk-of-harm to sterilization validation product functionality, meeting the High severity threshold.
Plain-English summary
3M Company is recalling 172,464 units of specific lot codes of Attest Super Rapid Readout Biological Indicators, Attest Super Rapid 5 Steam-Plus Challenge Packs, and Attest Super Rapid Readout Steam Challenge biological indicators. These devices are used to monitor and validate steam sterilization processes. The recall is due to potential defects in the caps of these biological indicators.
During steam sterilization cycles at temperatures of 132°C and 135°C, the caps of affected units may melt, deform, and/or crack. This defect could compromise the integrity and function of the biological indicators.
The affected products have been distributed worldwide, including throughout the United States and to Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, and Taiwan. Specific affected lot codes with expiration dates are: 33P3EF (exp. 12/27/2024), 33P4ND (exp. 01/01/2025), 33P4NR (exp. 01/01/2025), 33P5CA (exp. 01/03/2025), and 33P5XT (exp. 01/06/2025).
If you have purchased or are using affected products, contact 3M for guidance on whether your product is included in this recall. Do not use affected units for sterilization validation until you have confirmed whether your product is recalled.
The recalled product
- Product
- 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
- Manufacturer
- 3M Company - Health Care Business
- Affected units
- 172,464
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- UDI/DI: 50707387787276( (shipper)
- Lot Codes: 33P3EF
- exp. 12/27/2024
- 33P4ND
- exp. 01/01/2025
- 33P4NR
- 33P5CA
- exp. 01/03/2025
- 33P5XT
- exp. 01/06/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by 3M Company - Health Care Business under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · 3M Company - Health Care Business
See all →- High3M Clarity Precision Orthodontic Attachments Recall for Improper Tooth Mating
FDA (Devices) · 2025-01-01
- High3M Tegaderm CHG I.V. Dressing Recalled for Foreign Contamination
FDA (Devices) · 2024-10-16
- Moderate3M Durapore Surgical Tape incorrectly labeled with extended shelf life
FDA (Devices) · 2024-05-01
- Moderate3M Tube Securement Devices Recalled for Missing Film Layer and Shape Defects
FDA (Devices) · 2024-04-10
- High3M Surgical Clipper Blade Assembly Recalled Due to Burn Risk
FDA (Devices) · 2024-02-28
Same hazard · product defect
See all →- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateMedline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals
FDA (Devices) · 2025-05-07
- HighCELL-DYN Ruby hematology analyzer system expiration date validation
FDA (Devices) · 2025-04-30
- HighMedline Procedure Kits with Defective Plastic Syringes Recalled for Safety
FDA (Devices) · 2025-04-02