Medical device recall: sterilization validator with incorrect incubation time
TERRAGENE S.A. is recalling 914 ASP BIOTRACE Auto Read 60 sterilization process challenge devices due to incorrect incubation time listed in the product instructions. The IFU lists 20 minutes instead of the correct 60 minutes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving an instruction error in the product documentation. No illnesses, injuries, or deaths have been reported. The hazard is theoretical—related to potential improper sterilization validation—but lacks confirmed incidents of harm.
Plain-English summary
TERRAGENE S.A. is recalling the ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device (REF 73135) distributed nationwide in the United States, specifically in California and Kentucky. A total of 914 units are affected by this recall.
The recall was issued because the Instructions for Use (IFU) for the device contains an error: it lists an incorrect incubation time of 20 minutes instead of the correct incubation time of 60 minutes. This process challenge device is used to validate steam sterilization processes. If users follow the incorrect incubation time specified in the IFU, the sterilization process validation may not be performed correctly.
Consumers and healthcare facilities that have received this device should stop using the recalled units and contact TERRAGENE S.A. for corrected instructions or a replacement device.
The recalled product
- Product
- ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Manufacturer
- TERRAGENE S.A.
- Hazard
- instruction-error
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 (8)
- Lot numbers: F40062
- F40064
- F40072
- F40074
- F40101
- F40116
- UDI-DI - 07798375772624 (primary packaging)
- 07798375772877 (secondary packaging) containing IFU Rev.A R0.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27