Smiths Medical Recalls Irrisept OR Bottle Assemblies Due to Sterility Risk
Smiths Medical is recalling 10,440 Irrisept OR bottle assemblies because leaking containers may compromise sterility, posing an infection risk.
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 recall is classified as FDA Class II and involves a risk of exposure to infectious agents, which aligns with the rubric criteria for Severe severity involving significant injury risk or hospitalization potential.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling 10,440 units of the Irrisept OR, Finished Bottle Assembly 450 ml STEP 1. The recall is due to a lack of sterility assurance, as leaking containers could lead to exposure to infectious agents.
The affected product is identified by Model # FB-A-400-107 and Lot Number 4J006. The units were distributed to facilities in Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, and Wisconsin.
Healthcare facilities should stop using the affected product and contact the manufacturer for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
- Affected units
- 10,440
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 # FB-A-400-107 Lot Number: 4J006
Distribution
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 →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19