Teleflex Visistat Skin Staplers Recalled for Sterility Deficiency
Teleflex Medical is recalling Visistat 35W disposable skin staplers because improper packaging seals mean sterility is not assured.
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 is classified as FDA Class II, and the hazard involves a risk of harm (infection) from a non-sterile medical device, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Teleflex Medical is recalling the WECK Visistat 35W Disposable Skin Stapler. The recall is due to a sterility deficiency where the packages are not sealed properly, meaning the sterility of the devices is not assured.
The affected product is a prescription-only, sterile medical device intended to close lacerations on the outer layer of the dermis for various surgical procedures. The recall involves 96,402 units distributed worldwide, including the United States and countries such as Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, and Thailand.
The specific product code is 528235. Affected lot numbers include 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006, and 73M1500130. Healthcare providers and facilities should stop using these devices and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic…
- Manufacturer
- Teleflex Medical
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 (7)
- Product Code: 528235
- Lot numbers: 73C1600693
- 73G1500681
- 73H1500255
- 73H1500256
- 73K1500618
- 73L1400006 and 73M1500130.
Distribution
Distributed nationwide across the United States.
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