Halyard SPINE Kit recalled for loose metal flakes in surgical instruments
AVID Medical is recalling Halyard SPINE surgical kits (Model EUOR004-02) due to loose metal flakes that may detach from sponge forceps and towel clamps. These flakes could potentially enter a patient's surgical site, causing local or foreign body 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: This is an FDA Class II recall for a medical device with risk of foreign body contamination in surgical sites. The source text indicates no reported illnesses or injuries, and the hazard is theoretical (metal flakes 'potentially could' detach). Per the rubric, theoretical hazards without reported injury score 3 (High).
Plain-English summary
AVID Medical, Inc. is recalling Halyard KIT, SPINE (Model Number EUOR004-02), a medical convenience kit used in surgical procedures. The recall involves 165 units distributed nationwide across the United States. The specific lot number affected is 1600550.
The recall is being issued due to loose metal flakes potentially detaching from sponge forceps and towel clamps in the kits. Metal flakes may enter a patient's surgical site undetected, posing a risk of local reactions or foreign body reactions.
Healthcare facilities and surgical centers should immediately discontinue use of affected kits from Lot 1600550. Contact AVID Medical, Inc. for instructions on returning or replacing the product. Any incidents or adverse reactions should be reported to the FDA.
The recalled product
- Product
- Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 165
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: 10809160366479 Lot Number: 1600550
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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