U.S. imports of Syringes, Needles, Catheters, Cannulae, and Similar Medical Instruments (SITC 87221) totaled $1.1B in August 2026, imported from 67 countries.
Importers of Syringes, Needles, Catheters, Cannulae, and Similar Medical Instruments paid $48.4M in duties in August 2026, an average duty rate of 4.39% — duty actually collected as a share of the imports that cleared customs, not the published tariff schedule.
Last updated: August 2026 dataHypodermic syringes, injection needles, intravascular catheters, and cannulae used in medical, surgical, or veterinary practice are among the highest-volume medical device imports entering the US, and all are subject to FDA device regulation — ranging from Class I exempt status for simple syringes to Class III premarket approval for certain specialized catheters. Section 301 additional duties have affected imports of these articles from China, prompting significant supply-chain diversification toward other manufacturing hubs. Importers must ensure that sterile articles are accompanied by appropriate sterility documentation and that the foreign manufacturer holds current FDA establishment registration.
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29.8K import shipments a month
FDA expects that sterile medical devices entering the US are manufactured under validated sterility assurance processes consistent with 21 CFR Part 820 (Quality System Regulation) or ISO 13485. While FDA does not require a specific sterility certificate at the port of entry, the importer of record is responsible for ensuring the device meets applicable standards, and FDA may request manufacturing records or sterility validation data during an import alert or examination.
Pre-filled syringes are typically regulated as combination products, with the primary mode of action determining the lead regulatory center (usually FDA's Center for Drug Evaluation and Research for drug-device combinations). Classification for tariff purposes generally follows the essential character of the combination; CBP has issued rulings treating pre-filled syringes as pharmaceutical preparations rather than medical devices in some cases, so a binding ruling is advisable.
Basic heading 6 of 419 in section 8
Basic heading 87221 · $1.1B of $46.9B
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Imports · August 2026
origin
Mexico and Costa Rica together supply 53% of it. China pays 14.7% duty; Mexico 1.1%.
customs district
Census does not publish district detail for this classification system.
destination
Census does not publish state detail for this classification system.
entry
Census does not publish port detail for this classification system.
ImportsExports
Imports
$1.1BYoY · free account
Exports
$818.7MYoY · free account
12-mo low · imports
Low · free accountOver the twelve months to August 2026, the U.S. imported $12.5B of Syringes, Needles, Catheters, Cannulae, and Similar Medical Instruments.
Through August 2026 · exports 11 of 12 months reported. Source: U.S. Census Bureau.