Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
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: The recall involves a medical device where a defect (tubing detachment) interrupts insulin delivery without an alarm. This poses a significant risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 13,041 boxes of ACCU-CHEK Tender I 17/110 infusion sets. The recall was initiated after the manufacturer, UnoMedical, identified a potential for the tubing to become detached at the connect/disconnect location.
If the tubing detaches, insulin delivery is interrupted. The source text notes that the pump will not alarm to notify the user if this detachment occurs. The affected products are catalog number 04541421001 and lots 5040427, 5044352, and 5061933. These products were distributed nationwide in the United States.
Consumers should check their infusion sets for the specific catalog and lot numbers listed above. If the product matches the recall criteria, users should stop using the device and contact Roche Diagnostics or their healthcare provider for instructions on replacement or return.
The recalled product
- 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
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 13,041
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 (3)
- Catalog: 04541421001 and lots: 5040427
- 5044352
- and 5061933.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Roche Diagnostics Operations, Inc. 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 12 products in this recall →Related recalls
Same manufacturer · Roche Diagnostics Operations, Inc.
See all →- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11
- HighThyroid receptor immunoassay recalled over variable results across instrument platforms
FDA (Devices) · 2026-01-14
- HighMedical Device Homocysteine Test Assay Recalled for Calibration Defects
FDA (Devices) · 2024-11-27
- HighRoche Creatine Kinase test reagents recalled for calibration errors
FDA (Devices) · 2024-10-02
- HighRoche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
FDA (Devices) · 2023-11-29
Same hazard · tubing detachment
See all →- HighPrecision Delivery Sets recalled due to potential tubing detachment
FDA (Devices) · 2023-02-15
- HighEdwards TruWave Pressure Monitoring Set Recalled for Potential Tubing Detachment
FDA (Devices) · 2021-07-07
- HighBlood Management System Pressure Tubing May Detach
FDA (Devices) · 2021-07-07
- HighPressure monitoring set recalled for potential pressure tubing detachment
FDA (Devices) · 2021-07-07
- ModerateEdwards TruWave Pressure Monitoring Set Tubing Detachment Recall
FDA (Devices) · 2021-07-07