Class II — ORIGIO, Inc
| Recalling firm | ORIGIO A/S |
|---|---|
| Registered facility | ORIGIO A/S (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration |
| Product | Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL |
| Quantity | Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511 |
| Distribution | Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates. |
| Initiated | 2014-06-20 |
| Classified | 2014-06-30 |
| Terminated | 2015-07-20 |
| Recall number | Z-1946-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ORIGIO, Inc (Z-1946-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68592/
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