CLASS II ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report

Medtronic Bio-Medicus Adult Cannula Kit recalled

Medtronic Perfusion Systems is recalling Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115, distributed nationwide in the US. The recall was initiated on 25 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001

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-2739-2026
FDA event ID: 99199
Recalling firm: Medtronic Perfusion Systems, Brooklyn Park, MN
Classification: Class II
Status: Ongoing
Recall initiated: 25 May 2026
FDA classified: 15 Jul 2026
Reported: 22 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

25 May 2026	Recall initiated by company
15 Jul 2026	Classified by FDA	+51 days
22 Jul 2026	Published in enforcement report	+7 days

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

Reason for recall

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula

Where it was distributed

Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.

Nationwide Arkansas California Florida Maryland Michigan North Carolina Pennsylvania Washington

Questions about this recall

Is Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115 recalled?

Yes. Medtronic Perfusion Systems recalled Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115 on 25 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2739-2026.

Why was it recalled?

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Which lots are affected?

MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001

Where was it sold?

Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.

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 Medtronic Perfusion Systems

All 116

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Device	CLASS II	Eopa Elongated One-Piece Arterial Cannula Blunt recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	EOPA Elongated One-Piece Arterial Cannula DIL TIP recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	Eopa Elongated One-Piece Arterial Cannula Blunt recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	EOPA 3D Arterial Cannula DIL TIP, intended for use recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS II	EOPA 3D Arterial Cannula, intended for use recalled	Medtronic Perfusion Systems	Packaging Defects	Nationwide

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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