CLASS II ONGOING Device recall · Reported 16 Sep 2026 · FDA Enforcement Report

Getinge PVC Thoracic Catheter, Firm PVC Straight recalled

Atrium Medical is recalling Getinge PVC Thoracic Catheter, Firm PVC Straight, distributed nationwide in the US. The recall was initiated on 7 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;

Quantity recalled256

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-3113-2026
FDA event ID: 99680
Recalling firm: Atrium Medical, Merrimack, NH
Classification: Class II
Status: Ongoing
Recall initiated: 7 Aug 2026
FDA classified: 4 Sep 2026
Reported: 16 Sep 2026
Type: Voluntary: Firm initiated
Reason category: Potency & Assay
Device type: Heart & Vascular Devices

Timeline

7 Aug 2026	Recall initiated by company
4 Sep 2026	Classified by FDA	+28 days
16 Sep 2026	Published in enforcement report	+12 days

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

Reason for recall

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Which lots are affected?

1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;

Where was it sold?

US Nationwide distribution.

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

Other products in this recall event

2 other products · FDA event 99680

This product is part of a recall event; the main page for the event is Getinge PVC Thoracic Catheter, Soft PVC Straight recalled.

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide

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, 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
12 Jun 2024Device	CLASS II	Advanta Vxt, 1gds, Fh, Str-tw recalled by Atrium Medical	Atrium Medical	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

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	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Temperature Abuse	Nationwide