FDAClass II · Medical device · Recall Z-3180-2026 · Recalled September 23, 2026
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Sam recall — embecta Medical II LLC
Agency report date: September 23, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Sam recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
Other medical device recalls from around the same time
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- INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP recall — CooperSurgical, Inc.FDA · September 30, 2026
- Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall — AVID Medical, Inc.FDA · September 23, 2026
- Haylard BASIC BIOPSY TRAY recall — AVID Medical, Inc.FDA · September 23, 2026
- Haylard CONTINUOUS NERVE BLOCK TRAY recall — AVID Medical, Inc.FDA · September 23, 2026
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.