Origio Pasteur Pipets Recalled Due to Packaging Sterility Breach
Origio, Inc. is recalling Pasteur Pipets used in IVF laboratories because a breach in the nylon pouch sterile barrier was identified.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level. The hazard is a packaging breach affecting sterility, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Origio, Inc. is recalling specific models of Pasteur Pipets used by embryologists in IVF laboratories. The affected models are PP-5.75-90, PP-9-90, PP-5.75-90PL, and PP-9-90PL. The recall involves lots with a labeled expiry date of May 2, 2015, or later.
The recall was initiated due to the identification of a packaging breach in the nylon pouch sterile barrier for the 3-pack configuration. This breach compromises the sterile barrier intended to protect the pipets.
A total of 32,760 boxes were distributed worldwide, including 4,093 in the US, 1,156 in Canada, and 27,511 in the EU and other regions. The products were distributed in numerous countries including Australia, China, Germany, Japan, and the United Kingdom. Users should stop using the affected pipets and contact the manufacturer for instructions.
The recalled product
- 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
- Manufacturer
- ORIGIO, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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.
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighQUADROX-iD Pediatric Oxygenator Recalled Due to Packaging Sterile Barrier Defect
FDA (Devices) · 2023-06-07
- SevereCustomed Vaginal Procedure Packs Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereCustomed OB Packs Recalled Due to Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- SevereCustomed Premium OB Pack Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- ModerateZimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures
FDA (Devices) · 2017-06-21
- HighPruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals
FDA (Devices) · 2025-05-21