American Surgical Cotton Balls Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling 34 boxes of strung cotton balls due to packaging defects that compromise sterility. The products were distributed worldwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls with potential for significant injury (such as loss of sterility in surgical products) are rated as Severe.
Plain-English summary
American Surgical Company is recalling 34 boxes of American Surgical Cotton Balls-Strung 1/8" (Ref Number: 30-07). These products are used as neurosurgical and nonneurosurgical sponges. The recall is due to defective product packaging that compromises the sterility of the cotton balls.
The affected lot numbers are 2015/11 AL, 2015/12 AS, 2015/12 BD, and 2015/12 DJ. The products were distributed worldwide, including the United States, 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.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should stop using the affected products and contact American Surgical Company for further instructions.
The recalled product
- Product
- American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- Manufacturer
- American Surgical Company
- Affected units
- 34
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 numbers: Lot Number 2015/11 AL 2015/12 AS 2015/12 BD 2015/12 DJ
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 →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereCustomed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCurity All Purpose Sponges Recalled Due to Compromised Sterility
FDA (Devices) · 2016-06-08
- SevereCustomed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Breast Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- CriticalCustomed Recalls Shoulder Arthroscopy Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10