Surgical forceps and clamps recall due to potential loose metal flakes
AVID Medical is recalling Halyard OR Endovascular Tray surgical kits due to loose metal flakes that could detach from forceps and clamps and potentially enter the surgical site.
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 Class II FDA recall of a surgical device where metal flakes could detach and enter a patient's surgical site, potentially causing local or foreign body reactions. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling Halyard OR Endovascular TRAY surgical convenience kits (Model SAMM048-15, Lot Numbers 1590860 and 1593416) due to a defect affecting the sponge forceps and towel clamps.
Small loose metal flakes may detach from these components. Metal flakes could potentially enter a patient's surgical site during use, which may cause local reactions or foreign body reactions.
The product was distributed nationwide in the United States.
The recalled product
- Product
- Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 24
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)
- GTIN: 10809160384206 Lot Number: 1590860
- 1593416
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 73 recalled by AVID Medical, 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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