EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA is recalling 327 EndoFLIP Systems because a software error incorrectly flags catheters as expired, making them unavailable for clinical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a functional defect that renders the device unavailable for use, but there are no reports of injury, illness, or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 327 EndoFLIP Systems manufactured by Covidien, LLC. The affected products include the ENDOFLIP 1 SYSTEM EF-100, REFURBISHED SYSTEM RFG-EF100, and DL ENDOFLIP 1, which are endoscopic measuring systems containing catheter components.
The recall is due to a defect in the system's 24-hour usage limit functionality. This error causes catheters to be incorrectly flagged as expired, rendering them unavailable for clinical procedures. The recall covers units distributed worldwide, including nationwide distribution in the United States and in numerous international countries such as Canada, the United Kingdom, Germany, and Australia.
Healthcare providers and facilities should stop using the affected EndoFLIP Systems and contact the manufacturer for instructions on how to proceed. Consumers are not directly affected as this is a medical device used in clinical settings.
The recalled product
- Product
- EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.
- Manufacturer
- Covidien, LLC
- Affected units
- 327
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 (1)
- 2026.
Distribution
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