10ML Syringe Luer Lock Recalled for Potential Blood Backfill Leakage
Fresenius Medical Care is recalling 124,773 boxes of 10ML Syringe Luer Lock syringes due to potential blood backfill leakage and foreign material contamination.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric. The potential for blood backfill leakage and foreign material in medical syringes directly impacts patient safety, even though no illnesses or injuries have been reported.
Plain-English summary
The 10ML Syringe Luer Lock with Needle (Part Number 15-10ML-0) is being recalled by Fresenius Medical Care Holdings, Inc. A total of 124,773 boxes have been distributed nationwide throughout the United States.
The recall was initiated due to a potential for blood backfill leakage and the presence of foreign material in the syringes. These defects pose a risk to patient safety during medical use.
All lots of the product with UDI-DI 16945060500125 are included in this recall. Healthcare providers and patients should immediately cease use of the recalled syringes and contact their supplier or Fresenius Medical Care Holdings, Inc. for return and replacement instructions.
The recalled product
- Product
- 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 124,773
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 (2)
- UDI-DI: 16945060500125
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Fresenius Medical Care Holdings, 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 3 products in this recall →Related recalls
Same manufacturer · Fresenius Medical Care Holdings, Inc.
See all →- Moderate5008X Blood Tubing Set connection errors FDA Class II recall
FDA (Devices) · 2026-07-15
- HighBicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- SevereDELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
Similar recalls
- HighBecton Dickinson Recalls 10 mL Syringes Due to Manufacturing Issues
FDA (Devices) · 2016-06-15
- HighBecton Dickinson Recalls 10 mL Syringes Due to Manufacturing Non-Conformities
FDA (Devices) · 2016-06-15
- HighArrow International Recalls 10 cc Luer-Slip Loss of Resistance Syringes
FDA (Devices) · 2018-06-06
- HighMedline Syringes Recalled Due to Leaks, Breakage, and Quality Issues
FDA (Devices) · 2024-06-12
- HighMedline Disposable Syringes Recalled for Inaccurate Volume Delivery
FDA (Devices) · 2024-06-12
- HighMedline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
FDA (Devices) · 2024-09-18