Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.
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 potential compromise of the sterile barrier for a medical device, which poses a risk of harm (infection) but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aspen Surgical Products, Inc. is recalling the 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case), Product Number 340005. These medical devices are intended for closed wound suction drainage.
The recall was initiated due to a potential compromise of the sterile barrier for the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System. A compromised sterile barrier could allow contamination of the sterile device.
The affected products were distributed worldwide, including in the United States (specifically LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, AZ, NJ, MO, GA, KS, WV, NE, and Puerto Rico) and internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador. Healthcare providers and patients should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
- Manufacturer
- Aspen Surgical Products, Inc.
- Category
- Medical Device — Wound Care
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)
- Product Number 340005
Distribution
Part of a larger recall action
This product is one of 19 recalled by Aspen Surgical Products, Inc. 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 19 products in this recall →Related recalls
Same manufacturer · Aspen Surgical Products, Inc.
See all →- HighMarco Shoulder Stabilization Kit Recall Due to Sterilization Failure
FDA (Devices) · 2021-09-08
- HighNorton Arm Kit surgical device recall due to sterilization failure
FDA (Devices) · 2021-09-08
- HighSurgical arm suspension kits recalled due to sterilization concerns
FDA (Devices) · 2021-09-08
- HighAspen Surgical Wound Drainage Kits Recalled for Sterility Concerns
FDA (Devices) · 2014-04-16
- HighAspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
FDA (Devices) · 2014-04-16
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