Device recall: BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for…

Class II FDA enforcement event 91438. Recall start date: 15 Dec 2022. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.

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 15 Dec 2022. The firm address in the FDA record is in Trumbull, CT. FDA put the recall in Class II. FDA event 91438 has 1 product record. The first FDA enforcement report date is 8 Feb 2023. The record gives the status Ongoing.

FDA enforcement report The 1 product record

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.

Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria,…

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

1 product record in the event.

FDA event 91438: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1044-2023	BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)	489 units	Class II	Ongoing	8 Feb 2023

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 2022: 839
Share of these events in Class II: 88%
Product records in this event: 1Median 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
16 Feb 2024	Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A	Device	Class II	3
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
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-1044-2023The 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.

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Cite this page

Recall Register. FDA enforcement event 91438. https://recallregister.com/fda/ii/91438/. 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: Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria,…
What quantity of product is in FDA event 91438?: The FDA record gives this quantity: 489 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?: 88% of the 839 device events that started in 2022 are in Class II.