Last updated: March 14, 2026

FDA Compliance Required

ASH recommends using leeches exclusively from FDA-cleared sources. Use of non-cleared leeches — whether wild-caught, imported from unregistered suppliers, or purchased from pet stores — creates product liability exposure and violates medical device regulations. All suppliers listed below hold active FDA 510(k) clearance under product code NRN.

FDA-Cleared Suppliers

Company	510(k) Number	Year	Notes
Ricarimpex SAS (France)	K040187	2004	First FDA clearance for medicinal leeches; breeding operations spanning 150+ years
Biopharm (UK) Ltd. (Wales)	K132958 / BK251217	2014	Supplies US market via Carolina Biological Supply Co.; educational resources available
Carolina Biological Supply Co.	K140907	2015	US-based distributor for Biopharm leeches; Burlington, NC

All three clearances are classified under FDA product code NRN (“Leech, Medicinal”). Ricarimpex supplies approximately 80,000+ leeches per year to the US market. Biopharm/Carolina Biological provide a secondary domestic source.

Species Clarification

Hirudo medicinalis vs. Hirudo verbana

A 2007 molecular study (Siddall et al.) demonstrated that the vast majority of commercially available leeches marketed as Hirudo medicinalis are actually Hirudo verbana, a closely related species previously considered a color variant. Both species are accepted for clinical use and fall under the same FDA product code NRN. The taxonomic distinction does not affect clinical efficacy — the salivary gland secretion profiles are functionally equivalent for therapeutic purposes.

Equipment & Supplies — Startup Checklist

The following categories represent the core equipment needed to establish a hirudotherapy practice. Total estimated startup cost: $2,000–5,000, excluding facility buildout.

Category	Items	Est. Cost (USD)
Leeches	Initial stock (50–100 leeches) from FDA-cleared supplier	$350–$1,500
Application supplies	Syringe guides, gauze pads, transparent barriers, forceps	$75–$200
Biohazard disposal	Sharps containers, regulated waste bags, pickup service	$50–$150/month
Monitoring equipment	BP cuff, pulse oximeter, thermometer	$150–$350
Emergency supplies	Epinephrine auto-injector, silver nitrate sticks, suture kit	$180–$450
Storage	Aquarium or container at 4–10°C, dechlorinated water, mini-fridge	$150–$320
Total	Excluding facility costs and professional fees	$2,000–5,000

Ordering & Storage

Ordering Tips

Most suppliers require 48–72 hours advance notice
Leeches ship overnight in insulated, temperature-controlled containers
Establish accounts with at least one primary and one backup supplier
Verify 510(k) clearance number before first purchase
Request a Certificate of Analysis with each shipment
Initial order: 50–100 leeches; reorder based on treatment volume

Storage Requirements

Temperature: 4–10°C (39–50°F) for long-term storage
Use dechlorinated water (aged tap water or dechlorinator additive)
Change water weekly minimum; more frequently in warm conditions
Low ambient light — leeches are photosensitive
Secure, labeled storage inaccessible to unauthorized personnel
Shelf life: healthy leeches remain viable for months with proper care

Inspect leeches upon arrival for vitality (active swimming, firm body tone, rapid response to touch). Reject and report any shipments with dead or sluggish specimens. Maintain a receiving log with date, supplier, quantity, lot number, and condition assessment.

Important Warnings

Critical Safety Rules

Violation of these rules creates serious clinical and legal risk.

Single-Use Medical Devices

Medicinal leeches are classified as single-use medical devices. NEVER reuse a leech on a second patient. After detachment, leeches must be killed (immersion in 70% ethanol or 10% formalin) and disposed of as regulated medical waste. Reuse creates catastrophic cross-contamination risk, including potential transmission of bloodborne pathogens.

Prohibited Sources

Pet stores — no FDA clearance, unknown species, potential parasites
Wild-caught — disease risk, species uncertainty, no quality control
Unregistered importers — regulatory violation, no traceability
Bait shops — non-medical species, chemical contamination

Always verify the supplier's 510(k) clearance number against the FDA 510(k) Premarket Notification Database before purchasing.

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