Agency classClass IIOur severity:Severe FDA (Devices)·Z-2178-2013·Announced 2013-09-18

Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination

The FDA is recalling Monoject flush syringes that may contain non-sterile water instead of saline or heparin, posing a risk of infection.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

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: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection from non-sterile water in intravenous products.

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 and Heparin Lock Flush Syringes manufactured by Covidien LLC. The recall affects 3,235,860 units distributed nationwide in the United States and in Bermuda. The specific lot numbers involved are 13A0084N, 13A0094, 13B0364, and 13C0514.

The recall was initiated because these sterile, single-use syringes may contain non-sterile water rather than the labeled saline or heparin solution. These products are intended for flushing and locking compatible intravenous administration sets and indwelling intravenous access devices. The presence of non-sterile water in a product intended for intravenous use creates a risk of infection or other adverse health consequences.

Healthcare facilities and consumers who have these specific syringes should stop using them immediately. Users should check the lot numbers on their syringes against the list provided by the FDA and contact their supplier or the manufacturer for instructions on returning the affected units.

The recalled product

Product: Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 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…
Manufacturer: Covidien LLC
Category: Medical Device — Syringes
Hazard: infection
contamination
Affected units: 3,235,860

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 13A0094 13B0364 13C0514

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 →

Same manufacturer · Covidien LLC

See all →

Moderate
EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
Moderate
Covidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
Moderate
Covidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Covidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Shiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10

Same hazard · infection