FDA product code LMF: Agent, Absorbable Hemostatic, Collagen Based

LMF is the FDA product code for agent, absorbable hemostatic, collagen based. It is a Class III device, regulated under 21 CFR 878.4490 and reviewed by the General and Plastic Surgery panel. Devices under LMF reach the market by PMA; FDA lists no cleared 510(k)s for it. 13 PMA applications cite this product code. FDA has posted 27 recalls for LMF devices, 5 initiated in the last five years.

Classification

Recalls for LMF devices

27 product recalls in 10 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-03-25.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• Q9953 — Injection, iron-based magnetic resonance contrast agent, per ml

Frequently asked questions

What is FDA product code LMF?

LMF is the FDA product code for agent, absorbable hemostatic, collagen based. It is a Class III device, regulated under 21 CFR 878.4490 and reviewed by the General and Plastic Surgery panel.

What device class is LMF?

Class III, regulation 21 CFR 878.4490. Typical premarket route: PMA.

Have LMF devices been recalled?

Yes: 27 product recalls across 10 recall events; the most recent began 2026-03-25.

Next steps

• Run an FDA pathway report with predicate devices for product code LMF
• Run a recall and safety report across every LMF manufacturer
• Watch product code LMF for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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