CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker recalled

Stryker is recalling Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, distributed in Minnesota, New Hampshire, New Jersey, New York, Ohio, Texas. The recall was initiated on 13 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 007047/UDI: 07613252632863
Quantity recalled19 kits

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-0287-2024
FDA event ID
93140
Recalling firm
Stryker, San Jose, CA
Classification
Class II
Status
Ongoing
Recall initiated
13 Sep 2023
FDA classified
9 Nov 2023
Reported
15 Nov 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

13 Sep 2023Recall initiated by company
9 Nov 2023Classified by FDA+57 days
15 Nov 2023Published 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

Expired product distributed

Product as listed by the FDA

Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.

Where it was distributed

US: NH, TX, NY, NJ, OH, MN OUS: None

MinnesotaNew HampshireNew JerseyNew YorkOhioTexas

Questions about this recall

Is Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker recalled?

Yes. Stryker recalled Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker on 13 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0287-2024.

Why was it recalled?

Expired product distributed

Which lots are affected?

Lot # 007047/UDI: 07613252632863

Where was it sold?

US: NH, TX, NY, NJ, OH, MN OUS: None

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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