American Surgical Telfa Sponges Recalled for Packaging Defects Compromising Sterility
American Surgical Company is recalling Telfa neurosurgical and nonneurosurgical sponges because defective packaging may compromise sterility.
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 (sterile medical device) where the hazard is compromised sterility, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
American Surgical Company is recalling 4 boxes of Telfa 1/2" x 1.5" sponges (Ref Number: 80-08, Lot number: 2015/11 BP). The recall is due to defective product packaging that compromises the sterility of the sponges.
The affected products are used for neurosurgical and nonneurosurgical purposes. The distribution was worldwide, including the United States and countries such as Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
Consumers and healthcare facilities should stop using the affected sponges and contact American Surgical Company for further instructions or a return.
The recalled product
- Product
- American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 4
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:2015/11 BP
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 91 recalled by American Surgical 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 91 products in this recall →Related recalls
Same manufacturer · American Surgical Company
See all →- HighAmerican Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect
FDA (Devices) · 2016-06-01
- HighAmerican Surgical Ultracot Sponges Recalled for Packaging Defect
FDA (Devices) · 2016-06-01
- HighAmerican Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
FDA (Devices) · 2016-06-01
- HighAmerican Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defects
FDA (Devices) · 2016-06-01
- HighAmerican Surgical Ray-Cot Sponges Recalled for Sterility Compromise
FDA (Devices) · 2016-06-01
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12