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 infection.
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: The recall involves a potential compromise of the sterile barrier for a medical device, which poses a risk of infection (harm) but the source text does not report any actual illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Aspen Surgical Products, Inc. is recalling the 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case), Product Number 340007. 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.
The affected products were distributed worldwide, including in the United States and internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of these devices.
Healthcare providers and consumers should stop using these specific sterile drainage kits immediately. Users should contact Aspen Surgical Products, Inc. for further instructions on how to return the affected devices.
The recalled product
- Product
- 10mm Drain Kit Flat Full 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 340007
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 Products Recalls Sterile Wound Drainage Kits
FDA (Devices) · 2014-04-16
- HighAspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
FDA (Devices) · 2014-04-16
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
Similar recalls
- HighCardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
FDA (Devices) · 2017-05-31
- HighAspen Surgical Recalls Wound Closures Due to Sterility Concerns
FDA (Devices) · 2013-08-28
- HighCardinal Health Recalls Jackson-Pratt Wound Drains Due to Sterility Concerns
FDA (Devices) · 2017-05-31
- HighCardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns
FDA (Devices) · 2017-05-31
- HighCardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains
FDA (Devices) · 2017-05-31
- HighCardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise
FDA (Devices) · 2017-05-31