Z-2875-2016Class II

Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source)...

Name: Z-2875-2016 Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source)...
Creator: Pentax of America Inc
Published: 2016-05-31
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2016-05-31 / Terminated / root cause: packaging

FDA source

Pentax of America Inc began a recall of Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy... on 2016-05-31. FDA classified it as Class II and gives the reason as "Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2875-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-31
Posted: 2016-09-22
Terminated: 2017-12-21
Recalling firm: PENTAX of America, Inc.
Product: Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Pentax Medical sent a U.S. Urgent Field Correction notice to all affected customers with a recall letter/return response form on May 31, 2016 via Fed Ex. Customers with questions were instructed to call 800-431-5880, ext. 2064.
Quantity in commerce: 1719 units
Distribution: Nationwide Distribution
Product codes and lots: EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2875-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2875-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-22

Product code EOQ

K131028Class IIPentax Video Bronchoscopes (Eb Family)Pentax Medical Company / cleared 2014-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)