CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report

BARD Dynamic Tip Steerable, Product Number recalled

Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable, Product Number 200131, distributed nationwide in the US. The recall was initiated on 10 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 00885825002930, Lot Numbers: 3966097, 4314254, 4490535, 4511367, 4517632, 4607771, 4762688, 4056491, 4401626, 4490540, 4511368, 4567842, 4628229, 4775309, 4137164, 4455383, 4490542, 4511369, 4567844, 4628232, 4875058, 4154024, 4463033, 4490544, 4511370, 4567866, 4628234, 5023284, 4165178, 4472622, 4495807, 4511372, 4567888, 4628242, 5023285, 4250497, 4490533, 4502016, 4511375, 4567898, 4665767, 5069705, 4300586, 4490534, 4511155, 4514004, 4607745, 4762686.

Quantity recalled61 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-2175-2026
FDA event ID: 98708
Recalling firm: Stryker Sustainability Solutions, Tempe, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 10 Apr 2026
FDA classified: 13 May 2026
Reported: 20 May 2026
Type: Voluntary: Firm initiated
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

10 Apr 2026	Recall initiated by company
13 May 2026	Classified by FDA	+33 days
20 May 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

Incomplete seals on sterile product

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

BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Where it was distributed

US Nationwide and the countries of Israel and Canada.

Nationwide

Questions about this recall

Is BARD Dynamic Tip Steerable, Product Number 200131 recalled?

Yes. Stryker Sustainability Solutions recalled BARD Dynamic Tip Steerable, Product Number 200131 on 10 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2175-2026.

Why was it recalled?

Incomplete seals on sterile product

Which lots are affected?

UDI 00885825002930, Lot Numbers: 3966097, 4314254, 4490535, 4511367, 4517632, 4607771, 4762688, 4056491, 4401626, 4490540, 4511368, 4567842, 4628229, 4775309, 4137164, 4455383, 4490542, 4511369, 4567844, 4628232, 4875058, 4154024, 4463033, 4490544, 4511370, 4567866, 4628234, 5023284, 4165178, 4472622, 4495807, 4511372, 4567888, 4628242, 5023285, 4250497, 4490533, 4502016, 4511375, 4567898, 4665767, 5069705, 4300586, 4490534, 4511155, 4514004, 4607745, 4762686.

Where was it sold?

US Nationwide and the countries of Israel and Canada.

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.

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