FDAClass IISeptember 4, 2019

Flexible Neuro-fiberscope recall

FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

Why was Flexible Neuro-fiberscope recalled?

The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

SERIAL NUMBER: 2161516, 2204079, 2172240, 2198276, 2062041, 2178784, 2198341, 2220959, 2210200, 2183837, 2188370, 2247464, 2248783, 2194154, 2244117, 2039298

Product
FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Recalling firm
Karl Storz Endoscopy
Quantity
22 scopes
Distribution
US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA
Recall date
September 4, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls