B. Braun Recalls Celsite Implantable Access Port Systems Due to Endotoxin
B. Braun Interventional Systems is recalling 11 Celsite Implantable Access Port Systems because endotoxin test results were out of specification.
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: The recall involves a high-risk pathogen (endotoxin) in an implantable medical device where no specific illnesses or injuries have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
B. Braun Interventional Systems is recalling 11 units of the Celsite Implantable Access Port System, model ST301. These are implantable port and catheter systems used for the administration of medication and fluids to patients.
The recall was initiated after the manufacturer, B. Braun medical France, received endotoxin test results that were out of specification for the peelable sheath (A1537). The affected units are identified by lot number 36896615.
The recall is limited to California and New York. Patients and healthcare providers should contact their healthcare provider or the manufacturer for instructions on what to do next.
The recalled product
- Product
- Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for…
- Manufacturer
- B. Braun Interventional Systems
- Hazard
- Affected units
- 11
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 number: 36896615
Distribution
Related recalls
Same hazard · endotoxin
See all →- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Craniotomy Kits Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighB. Braun Recalls SAFSITE Injection Sites and IV Sets Due to Leakage
FDA (Devices) · 2014-02-26
- HighB. Braun Recalls CE17T Continuous Epidural Sets Due to Leakage
FDA (Devices) · 2018-10-10
- HighB. Braun Medical Recalls Epidural Anesthesia Kits Due to Leakage
FDA (Devices) · 2018-10-10
- HighB. Braun Medical Recalls CE18TIN Epidural Set Connectors
FDA (Devices) · 2018-10-10
- HighIV extension set recall for potential joint failure and leakage risk
FDA (Devices) · 2022-10-26
- HighB. Braun Medical Recalls CE18TKST Epidural Catheter Connectors
FDA (Devices) · 2018-10-10