CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report

Tranberg MR Cannula recalled by Clinical Laserthermia Systems

Clinical Laserthermia Systems Ab is recalling Tranberg MR Cannula, distributed nationwide in the US. The recall was initiated on 1 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot ID: 116539201117 and 116539030718 M

Quantity recalled40 units

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-1780-2021
FDA event ID: 87808
Recalling firm: Clinical Laserthermia Systems Ab, Lund
Classification: Class II
Status: Terminated
Recall initiated: 1 Apr 2021
FDA classified: 3 Jun 2021
Reported: 9 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

1 Apr 2021	Recall initiated by company
3 Jun 2021	Classified by FDA	+63 days
9 Jun 2021	Published in enforcement report	+6 days

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

Reason for recall

single use devices labeled as sterile may not have been adequately sterilized

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.

Nationwide California Maryland Texas

Stores named: Walmart

Questions about this recall

Why was it recalled?

single use devices labeled as sterile may not have been adequately sterilized

Which lots are affected?

Lot ID: 116539201117 and 116539030718 M

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.

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.

Other products in this recall event

2 other products · FDA event 87808

This product is part of a recall event; the main page for the event is Tranberg MR Stylet recalled by Clinical Laserthermia Systems.

Reported	Class	Recall	Company	Reason	Where
9 Jun 2021	CLASS II	Tranberg MR Stylet recalled by Clinical Laserthermia Systems	Clinical Laserthermia Systems Ab	Sterility	Nationwide
9 Jun 2021	CLASS II	Tranberg Laser Applicator Non-cooled, Diffuser, 12 m recalled	Clinical Laserthermia Systems Ab	Sterility	Nationwide

More recalls from Clinical Laserthermia Systems Ab

All 3

Reported	Class	Recall	Company	Reason	Where
9 Jun 2021Device	CLASS II	Tranberg Laser Applicator Non-cooled, Diffuser, 12 m recalled	Clinical Laserthermia Systems Ab	Sterility	Nationwide
9 Jun 2021Device	CLASS II	Tranberg MR Stylet recalled by Clinical Laserthermia Systems	Clinical Laserthermia Systems Ab	Sterility	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	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide