CLASS II ONGOING Device recall · Reported 23 Nov 2022 · FDA Enforcement Report

Atrium Ocean Wet Suction Water Seal Chest Drain- Product recalled

Atrium Medical is recalling Atrium Ocean Wet Suction Water Seal Chest Drain- Product, distributed nationwide in the US. The recall was initiated on 18 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226

Quantity recalled24 units (4cases/6)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0235-2023
FDA event ID: 91043
Recalling firm: Atrium Medical, Merrimack, NH
Classification: Class II
Status: Ongoing
Recall initiated: 18 Oct 2022
FDA classified: 15 Nov 2022
Reported: 23 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

18 Oct 2022	Recall initiated by company
15 Nov 2022	Classified by FDA	+28 days
23 Nov 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000

Where it was distributed

US Nationwide distribution in the state of VA.

Nationwide Virginia

Questions about this recall

Is Atrium Ocean Wet Suction Water Seal Chest Drain- Product recalled?

Yes. Atrium Medical recalled Atrium Ocean Wet Suction Water Seal Chest Drain- Product on 18 Oct 2022. The recall is Class II and its status is Ongoing. Recall number Z-0235-2023.

Why was it recalled?

Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.

Which lots are affected?

UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226

Where was it sold?

US Nationwide distribution in the state of VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Atrium Medical

All 153

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide
16 Oct 2024Device	CLASS II	iCast Covered Stent, 6MMx16MMx120CM recalled by Atrium Medical	Atrium Medical	Other	Nationwide
12 Jun 2024Device	CLASS II	Advanta Vxt, 1gds, Nh, Str-sw recalled by Atrium Medical	Atrium Medical	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide