Sterile Kelly Hemostat Recalled Due to Weak Seals
Medline's STERILE STRT KELLY HEMOSTAT (SK8039S) is being recalled due to weak seals that could compromise sterility, increasing the risk of contamination and infection. The recall affects 21,440 units distributed nationwide.
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: This is a risk-of-harm medical device recall (sterile surgical instrument) where a sterility breach could lead to infection. No illnesses or injuries have been reported, and the product is classified as FDA Class II. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Medline Industries is recalling the STERILE STRT KELLY HEMOSTAT (SK8039S), Item No. 66695, a surgical instrument used in medical procedures. The recall involves 21,440 units that were distributed nationwide.
The hemostats have been found to have weak seals that may result in a breach of sterility. This breach may not be detectable to the user, which could increase the risk of contamination and infection when the instrument is used in surgical procedures.
Affected healthcare facilities and providers should immediately stop using products from lot 2023011990 and contact Medline for return instructions. The affected lot can be identified by UDI 00653160024869 (individual unit) and 60653160024861 (case).
The recalled product
- Product
- STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 21,440
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 (2)
- UDI: 00653160024869 (ea) 60653160024861 (case)
- Lot 2023011990
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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