Aquabiliti saline flush syringes recalled for potential sodium chloride content deficiency
MRP, LLC is recalling AQUABILITI AQUASTAT saline flush syringes because they may fail to meet USP standards for sodium chloride content after 12 months.
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 3/5 (High).
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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard is a potential quality defect involving failure to meet USP specifications for sodium chloride content, affecting a risk-of-harm product where injury has not yet been reported.
Plain-English summary
MRP, LLC, doing business as Aquabiliti, is recalling AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringes in multiple lot numbers. The product consists of 5mL and 3mL fill volumes in 12mL syringe barrels, with reference numbers 2T0805 and 2T0807. Approximately 3,080,000 syringes have been recalled.
The syringes may fail to meet USP specifications for sodium chloride content after 12 months of storage. This potential quality defect could affect the product's ability to perform as intended.
The recalled syringes were distributed nationwide in Colorado, Florida, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Affected lot numbers with specific expiration dates are available in the FDA's recall notice.
The recalled product
- Product
- AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
- Manufacturer
- MRP, LLC dba Aquabiliti
- Affected units
- 3,080,000
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 (20)
- REF 2T0805 - Lot numbers KH04910
- exp. 1/11/2024
- KH04930
- exp. 3/13/2024
- KH04954
- exp. 5/22/2024
- KH04975
- exp. 8/2/2024
- KH04990
- exp. 9/6/2024
- KH05020
- exp. 10/23/2024
- KH05022
- exp. 10/24/2024
- KH05043
- exp. 11/13/2024
- KH05066
- exp. 12/13/2024
- KH05068
- exp. 12/14/2024
Distribution
Related recalls
Other medical device recalls
- ModerateDRG Sperm Ab ELISA Recalled for Potential False Negative Results
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateAMUSA Recalls 0.9% Sodium Chloride Flush Syringes Due to Incorrect Expiration Date
FDA (Devices) · 2015-06-10
- LowAmsino Medical Recalls Mislabeled 0.9% Sodium Chloride Flush Syringes
FDA (Devices) · 2012-09-26
- ModerateAMUSA Sterile Field Flush Syringe Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2015-06-24
- HighPrefilled saline flush syringes recalled over sodium chloride concentration shortfall
FDA (Devices) · 2025-10-29
- SevereAvella Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2018-07-25
- SevereMonoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination
FDA (Devices) · 2013-09-18