FDAJanuary 7, 2020device
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Sterile drapes packaged in an unsealed pouch.
What to do
FDA enforcement status: Ongoing
Brands named
stryker
UPCs
1085870100632910858701006282
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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