Reported Apr 24, 2024 · Ongoing

Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0…

Cook Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

9 of 9 products

Products covered by this recall
Model / numberProduct as published
DCHN-18-10.0NUMBER (GPN): 1)
DCHN-18-10.0-U2)
DCHN-18-15.03)
DCHN-22-10.04)
DCHN-22-10.0-U5)
DCHN-22-15.06)
DCHN-22-15.0-U7)
DCHN-22-20.08)
DCHN-22-20.0-U9)
Lot codes and dates

9 of 9 products

Products covered by this recall
#BarcodesProduct as published
100827002015593DCHN-18-10.0 (01)00827002015593(17) 15787141, 15787142, 15787693, 15794668, 15794669, 15794728, 15797998
200827002050402DCHN-18-10.0-U (01)00827002050402(17) NS15781793, NS15781794, NS15783895 NS15783896, NS15783899, NS15783900, NS15784336, NS1580853,5 NS15808536, NS15808537
300827002008502DCHN-18-15.0 (01)00827002008502(17) 15595244
400827002008526DCHN-22-10.0 (01)00827002008526(17) 15628472
500827002039780DCHN-22-10.0-U (01)00827002039780(17) 15614507
600827002000124DCHN-22-15.0 (01)00827002000124(17) 15628470, 15785990,15791249 15794719
700827002033146DCHN-22-15.0-U (01)00827002033146(17)15784638, 15784722,15784724, 15795935, 15797991, 15797992
800827002000131DCHN-22-20.0 (01)00827002000131(17) 15629865
900827002043381DCHN-22-20.0-U (01)00827002043381(17) NS15808547
Amount recalled
6,178 units

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

Why it was recalled

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.