Tepha GalaSHAPE 3D Medical Device Recalled for Endotoxin Specification Exceedance
Tepha Incorporated is recalling 29 units of GalaSHAPE 3D medical devices because endotoxin levels slightly exceeded specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text indicates a minor deviation where endotoxin values 'slightly exceeded' specifications without reporting of injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Tepha Incorporated is recalling 29 units of the GalaSHAPE 3D medical device, product code SH3D03. This bioresorbable scaffold is indicated for soft tissue support and repair in plastic, reconstructive, and general soft tissue surgeries.
The recall was initiated because endotoxin values from testing of retained samples slightly exceeded the established specification. The affected units are identified by Lot Number 160294.
The devices were distributed nationwide to Indiana, California, Florida, Michigan, Nevada, and Montana. Healthcare providers and patients should contact Tepha Incorporated for further instructions regarding the return or replacement of these specific units.
The recalled product
- Product
- GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the…
- Manufacturer
- Tepha Incorporated
- Hazard
- Affected units
- 29
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: 160294
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
- HighSoft tissue repair matrix recalled due to possible endotoxin contamination
FDA (Devices) · 2023-07-12
- HighSurgiMend 3.0 Soft Tissue Graft Recalled for Endotoxin Testing Defect
FDA (Devices) · 2023-07-12
- HighPriMatrix Dermal Repair Scaffold recalled due to endotoxin testing issues
FDA (Devices) · 2023-07-12
- HighSurgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin Levels
FDA (Devices) · 2024-11-06
- HighSurgical Patties and Strips Recalled for Elevated Endotoxin Levels
FDA (Devices) · 2024-11-06
- HighSurgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin
FDA (Devices) · 2024-11-06