Surgical forceps and clamps recalled due to detachable metal flakes
AVID Medical is recalling Halyard CPT surgical convenience kits because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites. No illnesses 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 a Class II medical device recall with a concrete risk of harm—metal flakes potentially contaminating surgical sites and causing local reactions or foreign body complications. However, no illnesses or injuries have been reported, making the actual impact theoretical rather than demonstrated. Per the rubric, a risk-of-harm medical device without reported injury warrants a High severity score.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard CPT PEDS ADULT CH PACK (Model SHAN431-07), a medical convenience kit distributed nationwide. The kit contains sponge forceps and towel clamps.
These instruments may have small loose metal flakes that could detach during use. If metal flakes enter a patient's surgical site undetected, they could cause local tissue reactions or foreign body complications.
The affected lot number is 1612993 (GTIN: 10809160427224). No illnesses or injuries have been reported in connection with this issue.
The recalled product
- Product
- Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 42
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: 10809160427224 Lot Number: 1612993
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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