Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detache Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detache
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
Catalog: 04541421001 and lots: 5040427, 5044352, and 5061933.
Products Sold
Catalog: 04541421001 and lots: 5040427, 5044352, and 5061933.
Roche Diagnostics Operations, Inc. is recalling ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of due to Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 11, 2026