CLASS II ONGOING Device recall · Reported 29 Dec 2021 · FDA Enforcement Report

Skinny Needle with Chiba Tip recalled by Cook

Cook is recalling Skinny Needle with Chiba Tip, distributed nationwide in the US. The recall was initiated on 13 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRPN 090010/GPN G14254: LOT NUMBER UDI 13977925 (01)00827002142541(17)240524(10)13977925 14030949 (01)00827002142541(17)240617(10)14030949 14054162 (01)00827002142541(17)240628(10)14054162 14116047 (01)00827002142541(17)240728(10)14116047 RPN 090010-ET/GPN G15290: LOT NUMBER UDI 14038615 (01)00827002152901(17)240618(10)14038615

Quantity recalled112 US, 240 OUS

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-0414-2022
FDA event ID: 89104
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Ongoing
Recall initiated: 13 Oct 2021
FDA classified: 22 Dec 2021
Reported: 29 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

13 Oct 2021	Recall initiated by company
22 Dec 2021	Classified by FDA	+70 days
29 Dec 2021	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

Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.

Product as listed by the FDA

Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA and the countries of France, Italy, and Mexico.

Nationwide Alabama California Indiana Louisiana Mississippi Montana North Carolina New York Oregon Pennsylvania Washington

Questions about this recall

Is Skinny Needle with Chiba Tip recalled?

Yes. Cook recalled Skinny Needle with Chiba Tip on 13 Oct 2021. The recall is Class II and its status is Ongoing. Recall number Z-0414-2022.

Why was it recalled?

Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.

Which lots are affected?

RPN 090010/GPN G14254: LOT NUMBER UDI 13977925 (01)00827002142541(17)240524(10)13977925 14030949 (01)00827002142541(17)240617(10)14030949 14054162 (01)00827002142541(17)240628(10)14054162 14116047 (01)00827002142541(17)240728(10)14116047 RPN 090010-ET/GPN G15290: LOT NUMBER UDI 14038615 (01)00827002152901(17)240618(10)14038615

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA and the countries of France, Italy, and Mexico.

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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