ORIGIO Sperm Wash 84050060DRecalls & reported problems

Origio A/S · ORIGIO Sperm Wash 60ml · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K153267); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Feb 16, 2024Class IIOpen, Classified
Low concentration of sodium pyruvate in the wash could compromise gamete development
Z-3298-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153267. One submission often covers many models, so check the product and lot details in each record.

Z-3296-2024 · Feb 16, 2024 · Open, Classified
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
Z-3297-2024 · Feb 16, 2024 · Open, Classified
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A

Device details

UDI-DI	`00888937816891`
Brand	ORIGIO Sperm Wash
Model	84050060D
Company	Origio A/S
Product code	MQL · Media, Reproductive
Class	Class 2
FDA submission	K153267
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): IVF medium

A solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.

Other Media, Reproductive devices

Vit Kit® - Freeze 90133-SO
Fujifilm Irvine Scientific, Inc. · Media, Reproductive
2 recalls0 reports
LifeGlobal® Media H5GT-060
Lifeglobal Group, LLC · MEDIA, REPRODUCTIVE
1 recall0 reports
LifeGlobal® Media LGGG-050
Lifeglobal Group, LLC · MEDIA, REPRODUCTIVE
1 recall0 reports
LifeGlobal® Media LGGG-100
Lifeglobal Group, LLC · MEDIA, REPRODUCTIVE
1 recall0 reports
LifeGlobal® Media LGGG-020
Lifeglobal Group, LLC · MEDIA, REPRODUCTIVE
1 recall0 reports
ISolate® 99264-2x100mL
Fujifilm Irvine Scientific, Inc. · Media, Reproductive
1 recall0 reports
LifeGlobal® Media GFT5-055
Lifeglobal Group, LLC · MEDIA, REPRODUCTIVE
1 recall0 reports

All Media, Reproductive devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page