Halyard FOOT ANKLE PACK surgical instruments recalled due to loose metal flakes
AVID Medical recalls Halyard FOOT ANKLE PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps that could enter surgical sites and cause local reactions.
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 potential for serious harm—loose metal fragments could enter surgical sites and cause reactions—but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score as 3 (High).
Plain-English summary
AVID Medical is recalling the Halyard FOOT ANKLE PACK Model Number EUOR005-02, a medical convenience kit containing sponge forceps and towel clamps. The affected lot number is 1589794, with 72 units distributed nationwide in the United States.
The product components may shed small loose metal flakes. These metal fragments could detach and undetectedly enter a patient's surgical site during use, potentially causing local reactions or foreign body reactions.
This is an FDA Class II recall.
The recalled product
- Product
- Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 72
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)
- GTIN: 10809160394595 Lot Number: 1589794
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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