Halyard Extremity Pack Surgical Instruments Recalled for Loose Metal Flakes
AVID Medical recalls Halyard Extremity Pack surgical instruments (model MMOK009-03) because small metal flakes may detach from sponge forceps and towel clamps and enter patients' surgical sites. No injuries have been reported.
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 involving a genuine risk of harm—metal flakes entering a surgical field could cause serious foreign body complications—but no patient injuries or illnesses have been reported. The hazard is serious in nature but remains theoretical at this time.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard Extremity Pack (model MMOK009-03), a medical convenience kit containing sponge forceps and towel clamps. The recalled lot (1589527) includes 62 units distributed nationwide in the United States.
The sponge forceps and towel clamps may shed small loose metal flakes during use. These flakes could detach from the components and potentially enter a patient's surgical site undetected.
Metal flakes in a surgical field may cause local tissue reactions or foreign body reactions. No patient injuries or illnesses related to this defect have been reported to date.
The recalled product
- Product
- Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 62
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: 10809160404188 Lot Number: 1589527
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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