The Recall Desk

FDA (Devices) recall action 95476

Folsom Metal Products, Inc. recalled 2 products on 2024-12-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-12-18
Critical
0
Units
48

Why these products were recalled

Units were not intended for commercial distribution and inadvertently distributed.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2024-12-18

    FDA Recalls DKS Disposable Kerrison System Surgical Instruments

    Folsom Metal Products recalls 42 sets of DKS Disposable Kerrison System surgical instruments inadvertently distributed without commercial distribution approval. Four units were not sterilized.

    Product
    DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Sma
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··2024-12-18

    Small DKS Disposable Kerrison System Inadvertently Distributed

    Small DKS Disposable Kerrison System instrument sets were inadvertently distributed when not intended for commercial distribution. Six sets (Lot 1578) were distributed to Kansas, Louisiana, Michigan, New York, and Texas.

    Product
    Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)
    Category
    Distribution
    5 states