Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination
Covidien LLC is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies this as an FDA Class II recall. According to the severity rubric, an FDA Class II recall is classified as Severe (Score 4), particularly given the risk of introducing non-sterile water into intravenous lines.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Monoject 0.9% Sodium Chloride Flush Syringes, 12 mL Syringe with 5 mL Fill, manufactured by Covidien LLC. The recall is due to the possibility that the syringes may contain non-sterile water while being labeled as saline or heparin. These sterile, single-use products are intended for flushing and locking compatible intravenous administration sets and indwelling intravenous access devices.
The affected product is identified by Product ID 8881570125 and Lot Number 13A0084N. The distribution pattern includes the United States nationwide and Bermuda. The source text does not specify the total number of units recalled or report any specific illnesses or injuries associated with the use of these products.
Healthcare facilities and consumers should stop using the affected syringes and contact their supplier or the manufacturer for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Syringes
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)
- Lot Numbers: 13A0084N
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Covidien LLC 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 9 products in this recall →Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Same hazard · non sterile water
See all →- HighMonoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water
FDA (Devices) · 2013-09-18
- SevereMonoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA (Devices) · 2013-09-18
- SevereMonoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA (Devices) · 2013-09-18