Lower riskMedical device recall · FDA · Published October 13, 2021
Cook Skinny Needle with Chiba Tip Recall: Black Debris May Cause Inflammation
Cook recalls Skinny Needle with Chiba Tip (RPN 090010, GPN G14254) due to potential black debris causing local inflammatory reactions. Affected units may need replacement.
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.
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Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
✎ GovInfoNow plain-language explainer
Cook is recalling Skinny Needle with Chiba Tip devices that may have black debris inside or on the surface. Using these products could cause inflammation at the site of use. Consumers should check the lot numbers listed in the recall notice. Read more at govinfonow.com/recall/61691-cook-skinny-needle-with-chiba-tip-recall-black-debris-may.
“Cook Skinny Needle with Chiba Tip Recall: Black Debris May Cause Inflammation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61691-cook-skinny-needle-with-chiba-tip-recall-black-debris-may. Based on FDA recall #Z-0414-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0414-2022%22&limit=1).
Cook Inc. recalled Skinny Needles with Chiba Tips on Oct. 13, 2021, after the FDA announced that black debris may be present on the needles, potentially causing local inflammatory reactions. The agency issued recall number Z-0414-2022 for the Class II device.
How to tell if you have it
Cook Skinny Needle with Chiba Tip
RPN 090010, 090010-ET
GPN G14254, G15290
UPC 00827002142541
Lot UDI 13977925 (01)00827002142541(17)240524(10)13977925
Lot UDI 14030949 (01)00827002142541(17)240617(10)14030949
Lot UDI 14054162 (01)00827002142541(17)240628(10)14054162
Lot UDI 14116047 (01)00827002142541(17)240728(10)14116047
Lot UDI 14038615 (01)00827002152901(17)240618(10)14038615
The hazard
The FDA stated that 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.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls include the Cook Flexor Check-Flo Introducer Ansel Modification recall (Nov. 12, 2021), the Cook Transseptal Needle Recall (Oct. 8, 2021), and the Cook Flexor Check-Flo Introducer Recall (Sept. 28, 2021). Additional similar product recalls include the Cook Ring Transjugular Intrahepatic Access Sets Recall (Nov. 26, 2025), the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), and the Cook Flexor Check-Flo Introducers and Sets recall (Nov. 26, 2025).
How to tell if you have this one
Check the product's lot number on the packaging or device. The affected units have specific lot numbers listed in the recall notice: RPN 090010/GPN G14254 with lot numbers starting with UDI 13977925 and RPN 090010-ET/GPN G15290 with lot number UDI 14038615.
Brand
Cook
Product
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot number on the device or packaging to determine if it is affected. Affected units have specific lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Indiana, Louisiana, Mississippi, Montana, New York, North Carolina, Oregon, Pennsylvania, Washington.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0414-2022 (October 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0414-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.