Stryker Endoscopy
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000004796 FEI 2936485
- Devices
- 104
- Registrations
- EUDAMEDFDA
- FDA recalls
- 278
What Stryker Endoscopy makes
Stryker Endoscopy manufactures the 780 nm SPY Portable Handheld Imaging (SPY-PHI) System, a handheld device for intraoperative fluorescence imaging, and autoclavable arthroscopes designed for repeated sterilization and surgical use.
The company’s products are classified under EU Device Classes I and II, with records held in the EUDAQS database (eudamed) and FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 104 devicesShowing 51-100 of 104
Company details
- EUDAMED SRN
- US-MF-000004796
- FDA FEI number
- 2936485
- EUDAMED status
- Active
- EUDAMED registered name
- Stryker Endoscopy
- Registered address
- 5900 Optical Court, 95138, San Jose, United States
- Website
- stryker.com
- [email protected]
- Phone
- 408-754-2000
- PRRC contact
- Kimberly Lynch
EUDAMED certificates
2 certificates1 valid, 1 expiredMDR 2next expiry 25 Feb 2031
TÜV Rheinland LGA Products GmbH 0197 2 certificates
- HZ 1192388-1 Active
Quality management system EU MDR
- Issued
- 25 Sep 2026
- Expires
- 25 Feb 2031
- Valid from
- 30 Sep 2026
- Reason
- Add device or group
- HZ 1192388-1 Expired
Quality management system EU MDR
- Issued
- 20 Dec 2025
- Expires
- 25 Feb 2026
- Reason
- Other
FDA recalls
FDA recall records list 278 recalls initiated by Stryker Endoscopy, the earliest on 2004-11-30 and the most recent on 2016-03-28. By recorded status: 278 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 28 Mar 2016 Z-1566-2016 Class II Terminated When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.
Full distribution text
- 28 Mar 2016 Z-1566-2016 Class II Terminated When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.
2015
- 3 Jun 2015 Z-1831-2015 Class II Terminated 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.
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- 3 Jun 2015 Z-1831-2015 Class II Terminated 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.
2014
- 17 Nov 2014 Z-0592-2015 Class II Terminated 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
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- 17 Nov 2014 Z-0593-2015 Class II Terminated 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
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- 17 Nov 2014 Z-0594-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0595-2015 Class II Terminated 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
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- 17 Nov 2014 Z-0596-2015 Class II Terminated 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
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- 17 Nov 2014 Z-0597-2015 Class II Terminated 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
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- 17 Nov 2014 Z-0598-2015 Class II Terminated 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
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- 17 Nov 2014 Z-0599-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0592-2015 Class II Terminated 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
Show the 25 most recent of 278 recalls
2014
- 17 Nov 2014 Z-0600-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0601-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0602-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0603-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0604-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0605-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0606-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0607-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0608-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0609-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0610-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0611-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0612-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0613-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0614-2015 Class II Terminated 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
Full distribution text
- 17 Nov 2014 Z-0600-2015 Class II Terminated 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
Frequently asked questions
How many devices does Stryker Endoscopy have in the registry?
The registry currently lists 104 devices for Stryker Endoscopy. Devices recorded under merged duplicate company entries are counted once.
Are there FDA recall records for Stryker Endoscopy?
FDA recall records list 278 recalls initiated by Stryker Endoscopy, the most recent initiated on 28 Mar 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Stryker Endoscopy?
EUDAMED lists 2 certificates for Stryker Endoscopy (quality management system) under MDR. The most recent was issued on 25 Sep 2026.