FDA Medical Device Recalls (openFDA)
ORIGIO, Inc: 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
- Recall number
- Z-1946-2014
- Recalling firm
- ORIGIO, Inc
- 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
- Status
- Terminated
- Initiated
- 2014-06-20
- Posted
- 2014-06-30
- Terminated
- 2015-07-20
- Reason
- Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
- Root cause
- Package design/selection
- Action
- Field Safety Corrective Action / Urgent Product Recall letter dated June, 2014.
- 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.
- Lot, serial or model codes
- CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL. Lots with labeled expiry date of May 2, 2015, or later.
- 510(k) numbers
- ["K000915"]
- PMA numbers
- not on file
- Product code
- MQK
- Firm FEI
- 1216677
- Firm city
- Charlottesville
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28