ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because 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) can interrupt insulin delivery without an alarm, posing a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 13,041 boxes of ACCU-CHEK Tender II 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 on the infusion sets.
If the tubing detaches, insulin delivery is interrupted, and the pump will not alarm to notify the user. The affected products are catalog number 04541499001 and lots 5051307, 5061935, and 5078667. These products were distributed nationwide in the United States.
Consumers should stop using the affected infusion sets and contact Roche Diagnostics for further instructions or a replacement.
The recalled product
- Product
- ACCU-CHEK Tender II 17/110 10 + 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 t
- 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: 04541499001 and lots: 5051307
- 5061935
- and 5078667.
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 · device defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22