Smiths Medical Recalls Portex 5ml Normal Saline Units Due to Sterility Issues
Smiths Medical is recalling 106,000 units of Portex 5ml Normal Saline due to leaking containers that may compromise sterility and expose patients to infectious agents.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential exposure to infectious agents without confirmed illness.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling 106,000 units of Portex 5ml Normal Saline (0.9%) Unit Dose. The recall is due to a lack of sterility assurance caused by leaking containers, which could lead to exposure to infectious agents.
The affected product is Model # UD9005, Lot Number B515. Distribution was worldwide, including nationwide distribution in the United States to numerous states and Puerto Rico, as well as to Austria, Canada, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
Healthcare providers and consumers should stop using the affected product and contact Smiths Medical for instructions on return or replacement.
The recalled product
- Product
- Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
- Affected units
- 106,000
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 (1)
- Model # UD9005 Lot Number: ¿B515
Distribution
Part of a larger recall action
This product is one of 13 recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company 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 13 products in this recall →Related recalls
Same manufacturer · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
See all →- CriticalMedline Prefilled 550 ml Sterile Bags Recalled for Leaking
FDA (Devices) · 2019-02-13
- CriticalSmiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking
FDA (Devices) · 2019-02-13
- HighSmiths Medical Recalls Intermed 550 ml Sterile Water Humidifiers
FDA (Devices) · 2019-02-13
- CriticalSmiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
FDA (Devices) · 2019-02-13
- HighSmiths Medical Recalls Portex Normal Saline Units Due to Sterility Concerns
FDA (Devices) · 2019-02-13
Same hazard · infection
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19