Device recall: Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A

Class II FDA enforcement event 95246. Recall start date: 16 Feb 2024. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Low concentration of sodium pyruvate in the wash could compromise gamete development

Class II, in the words of FDA

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

CooperSurgical, Inc. started this device recall on 16 Feb 2024. The firm address in the FDA record is in Trumbull, CT. FDA put the recall in Class II. FDA event 95246 has 3 product records. The first FDA enforcement report date is 2 Oct 2024. The record gives the status Ongoing.

FDA enforcement report The 3 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide.

Recalling firm

CooperSurgical, Inc., Trumbull, CT.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

3 product records in the event.

FDA event 95246: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-3296-2024	Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A	980 units	Class II	Ongoing	2 Oct 2024
Z-3297-2024	Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A	2680 units	Class II	Ongoing	2 Oct 2024
Z-3298-2024	Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D	770 units	Class II	Ongoing	2 Oct 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2024: 970
Share of these events in Class II: 87%
Product records in this event: 3Median of the firm: 1
Events of the firm on the register: 57

Other events of the firm

Other FDA enforcement events of CooperSurgical, Inc.
Initiated	Product (first record)	Type	Class	Records
11 Jun 2025	HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterograph	Device	Class II	3
15 Nov 2024	Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electric	Device	Class II	6
31 Jul 2024	Silver-Plated Copper Sims Uterine Sound, Part Number 64-600	Device	Class II	2
20 Dec 2023	global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Cult	Device	Class II	1
29 Aug 2023	Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Re	Device	Class II	1
13 Feb 2023	Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Num	Device	Class II	1
15 Dec 2022	BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantati	Device	Class II	1
20 Oct 2022	NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540	Device	Class II	1
12 Aug 2022	Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I	Device	Class II	2
13 Jun 2022	LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055	Device	Class II	1

CooperSurgical, Inc.: all 57 events

Official channels

FDA enforcement report Z-3296-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 95246. https://recallregister.com/fda/ii/95246/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide.
What quantity of product is in FDA event 95246?: The event has 3 product records. The first record gives this quantity: 980 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?: 87% of the 970 device events that started in 2024 are in Class II.