Stryker Endoscopy
5900 Optical Ct, SAN JOSE, CA, US
Registered product codes
110 product codes
Recent MDR events
19,609 on file
- PKG, 3/32 FEMORAL EYELOOP DRILL (BOX OF 6)Jul 29, 2026Malfunction0002936485-2026-00543
- PKG., 18 X 3/32 FEMORAL EYELOOP DRILL (BOX OF 6)Jul 29, 2026Malfunction0002936485-2026-00542
- 1588 AIM CAMERA CONTROL UNIT CCU - INTERNATIONAL KITJul 29, 2026Malfunction0002936485-2026-00544
- PKG. ASSY. STRYKEFLOW 2 WITH TIPJul 28, 2026Malfunction0002936485-2026-00518
- PKG. ASSY. STRYKEFLOW 2 WITH TIPJul 28, 2026Malfunction0002936485-2026-00520
- SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM INTERNATIONAL KIJul 28, 2026Malfunction0002936485-2026-00519
- CROSSFLOW DAY-USE INFLOW CASSETTE TUBING EACH - ORDER MULTIPLES OF 10Jul 28, 2026Malfunction0002936485-2026-00522
- CROSSFLOW INTEGRATED ARTHROSCOPY PUMP - INTERNATIONAL KITJul 28, 2026Malfunction0002936485-2026-00521
- CROSSFLOW DAY-USE INFLOW CASSETTE TUBING EACH - ORDER MULTIPLES OF 10Jul 28, 2026Malfunction0002936485-2026-00523
- CROSSFLOW INTEGRATED ARTHROSCOPY PUMP - INTERNATIONAL KITJul 28, 2026Malfunction0002936485-2026-00524
Recalls
278 on file
- TerminatedJun 24, 2015
Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.
View FDA record ↗ - TerminatedDec 12, 2014
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
View FDA record ↗ - TerminatedDec 12, 2014
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
View FDA record ↗ - TerminatedDec 12, 2014
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
View FDA record ↗ - TerminatedDec 12, 2014
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
View FDA record ↗ - TerminatedDec 12, 2014
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
View FDA record ↗ - TerminatedDec 12, 2014
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
View FDA record ↗ - TerminatedDec 12, 2014
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
View FDA record ↗ - TerminatedDec 12, 2014
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
View FDA record ↗ - TerminatedDec 12, 2014
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
View FDA record ↗
Compliance history
Matched by FEI 2936485.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.