Z-0403-2016Class II

Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD...

Name: Z-0403-2016 Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD...
Creator: Olympus Corporation of the Americas
Published: 2015-11-17
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2015-11-17 / Terminated

FDA source

Olympus Corporation of the Americas began a recall of Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm... on 2015-11-17. FDA classified it as Class II and gives the reason as "A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0403-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-17
Posted: 2015-12-10
Terminated: 2017-01-24
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
Product code: HET Laparoscope, Gynecologic (And Accessories)
Reason for recall: A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.
FDA root cause: Unknown/Undetermined by firm
Action: Olympus Corporation of Americas sent a letter dated November 25, 2015, to all affected customers to inspect the serial #'s to identify if the affected lots were in inventory and discontinue of the affected lots. Then return all aftected lots for repair and service. Customers were instructed to contact the Customer Care Center at 800-537-5739, Option 2 for instructions on returninng the ENDOEYE for repair and service. The form should be faxed to 484-896-7128. Customers with questions were instructed to call 484-896-5688.
Quantity in commerce: 182
Distribution: US Nationwide Distribution including these states: NE, IL, FL, TX, OH, PA, IN, CA, NY, AL, ND, GA, AK, MI, WA, MS, NJ, IA, AZ, and RI.
Product codes and lots: Serial numbers 622483, 622523, 622553, 622566, 622568, 622569, 622573, 622576, 622614, 622615, 622616, 622617, 622618, 622619, 622620, 622632, 622643, 622644, 622645, 622646, 622647, 622654, 622655, 622656, 622657, 622658, 622664, 622666, 622667, 622687, 622688, 622693, 622704, 622705, 622706, 622710, 622711, 622712, 622718, 622719, 622720, 622722, 622723, 622750, 622753, 622764, 622766, 622767, 622769, 622771, 622773, 622775, 622777, 622778, 622785, 622789, 622795, 622797, 622798, 622801, 622806, 623624, 623626, 623629, 623637, 623638, 623639, 623641, 623661, 623669, 623671, 623672, 623673, 623677, 623687, 623688, 623705, 623709, 623713, 623719, 623720, 623722, 623723, 623729, 623730, 623731, 623735, 623736, 623737, 623738, 623739, 623740, 623741, 623742, 623743, 623747, 623749, 623750, 623751, 623752, 623776, 623778, 623784, 623786, 623787, 623788, 623799, 623800, 623801, 623802, 624004, 624005, 624006, 624008, 624011, 624012, 624016, 624017, 624018, 624019, 624024, 624028, 624030, 624041, 624042, 624046, 624054, 624055, 624056, 624057, 624064, 624066, 624070, 624071, 624073, 624076, 624077, 624080, 624082, 624089, 624099, 624100, 624101, 624104, 624107, 624109, 624110, 624112, 624114, 624117, 624119, 624121, 624151, 624158, 624162, 624167, 624170, 624618, 624622, 624643, 624678, 624679, 624682, 624683, 624720, 622539, 622540, 622570, 622572, 623734, 623748, 624739, and 624741.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0403-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0403-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-10

Product code HET

K111788Class IIEndoeye Hd IIOlympus America, Inc. / cleared 2012-01-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)