Olympus Corporation of the Americas: Medical Device Recall in 2015 - (Recall #: Z-0403-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 17, 2015

Date Posted: December 16, 2015

Recall Number: Z-0403-2016

Event ID: 72713

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.

Status: Terminated

Product Quantity: 182

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated