NuStat Trauma Pad XR Hemafiber Recalled for Elevated Endotoxin Levels
Beeken Biomedical is recalling NuStat 8-by-12-inch Trauma Pad XR Hemafiber in a 5-pack because endotoxin levels exceeded allowable limits. The recall affects 15 units distributed in Missouri.
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: FDA Class II classification applies. No hospitalization or injury is reported, so the Class II hospitalization criterion for Score 4 does not apply. Endotoxin contamination in a sterile internal-use medical device is a risk-of-harm product where injury has not yet been reported, meeting the High (3) severity criterion.
Plain-English summary
Beeken Biomedical, LLC is recalling NuStat 8-by-12-inch Trauma Pad XR Hemafiber, a sterile medical device designed for temporary control of internal organ space bleeding. The product is sold in 5-packs under lot code 20C015.
The recall was initiated because endotoxin levels in the product exceeded allowable limits. Elevated endotoxin in a sterile internal-use medical device poses a potential risk of bacterial contamination.
This recall affects 15 units that were distributed in Missouri.
The recalled product
- Product
- NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
- Manufacturer
- Beeken Biomedical, LLC
- Hazard
- Affected units
- 15
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 Code: 20C015 UDI: 00850392006544
Distribution
Distributed in 1 state:
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
- HighBiomet Recalls Custom Knee Prosthesis Due to Potential Endotoxin Levels
FDA (Devices) · 2020-06-03
- HighTrevo NXT neurovascular devices recalled for inadequate endotoxin testing
FDA (Devices) · 2024-06-05
- HighStryker Neurovascular Microcatheter Recall Due to Inadequate Endotoxin Testing
FDA (Devices) · 2024-06-05
- HighBiomet Recalls Shoulder Implant Components Due to Endotoxin Levels
FDA (Devices) · 2020-06-03
- HighMedtronic NIM EMG Endotracheal Tubes Recalled for Exposed Wire Hazard
FDA (Devices) · 2017-01-04
- HighNeurovascular devices recalled due to inadequate endotoxin testing
FDA (Devices) · 2024-06-05