Food, drugs, devices › CooperSurgical, Inc.

Device recall: Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical I

FDA enforcement event 85139 · Class III · initiated 28 Feb 2020 · status Terminated · terminated 11 Aug 2020

DeviceVoluntary: Firm initiated1 product recordTrumbull, CT

FDA enforcement event 85139 is a device recall by CooperSurgical, Inc. of Trumbull, CT, initiated 28 Feb 2020 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 3% of the 916 device enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 11 Aug 2020. Initiation: voluntary: firm initiated. CooperSurgical, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

CooperSurgical, Inc., Trumbull, CT.

Reason for recall

"Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years."

Distribution

"International distribution to Japan only."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1713-2020	Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.	—	Class III	Terminated	22 Apr 2020

Context

3%of 2020 device events are Class III916 events that year

1product record in this eventfirm median: 1

57events on this register for the firm

Other enforcement events for 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
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

All 57 events for CooperSurgical, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "International distribution to Japan only."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 11 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.