CLASS IIONGOINGDevice recall · Reported 20 Nov 2024 · FDA Enforcement Report
Halyard Interventional Tray - Medical convenience kits recalled
Avid Medical is recalling Halyard Interventional Tray - Medical convenience kits, distributed nationwide in the US. The recall was initiated on 20 Sep 2024 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codesGTIN: 10809160348895 Lot Number: 1608213, 1610445, 1611447, 1615322, 1619673
Quantity recalled300 units
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
Which lots are affected?
GTIN: 10809160348895 Lot Number: 1608213, 1610445, 1611447, 1615322, 1619673
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.