Surgical arm suspension kits recalled due to sterilization concerns
Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits due to bioburden levels exceeding sterilization validation limits. This may compromise the sterile field and increase infection risk.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a theoretical risk of surgical site infection due to inadequate sterilization validation, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aspen Surgical Products, Inc. is recalling Jessie Sterile Arm Suspension Kits (Product Code 711300, previous code 100401, including Sample Kit S711300). A total of 1,429 units were distributed nationwide across the United States.
The product was manufactured with bioburden levels (microbial contamination) that exceeded the limits of the sterilization process validation. As a result, Aspen cannot provide full assurance that the kits were effectively sterilized. This may compromise the sterile field during surgical use and increase the risk of surgical site infection.
The recall affects all lots manufactured between July 9, 2019 and July 9, 2021. No foreign distribution has been identified.
Healthcare providers and facilities should contact Aspen Surgical Products immediately to discuss whether their inventory is affected and to arrange for product replacement or testing.
The recalled product
- Product
- Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
- Manufacturer
- Aspen Surgical Products, Inc.
- Affected units
- 1,429
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 (3)
- All lots manufactured between July 9
- 2019 to July 9
- 2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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