CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report
The NAV3i Platform Power Box supplies the electrical recalled
Stryker Instruments Div. of Stryker is recalling The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker, distributed in 10 states. The recall was initiated on 13 May 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1716-2014
- FDA event ID
- 68261
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2014
- FDA classified
- 4 Jun 2014
- Reported
- 11 Jun 2014
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 13 May 2014 | Recall initiated by company | |
| 4 Jun 2014 | Classified by FDA | +22 days |
| 11 Jun 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints
Product as listed by the FDA
The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).
Where it was distributed
Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.
ArkansasCaliforniaIndianaLouisianaMassachusettsMarylandMichiganMontanaNevadaTexas
Questions about this recall
Why was it recalled?
The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints
Which lots are affected?
Stryker Product Number: 7700-853-000 Stryker Serial Numbers: 10004
Where was it sold?
Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 68261| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The Stryker NAV3i Platform is a mobile cart platform recalled | Stryker Instruments Div. of Stryker | Device Malfunction | 10 states |
More recalls from Stryker Instruments Div. of Stryker
All 161| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Triton Sponge System recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
| Device | CLASS II | Triton Canister System (finished part numbers FG recalled | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
| Device | CLASS II | SurgiCount+ System Application recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | KS, ME |
| Device | CLASS II | Stryker Zyphr Disposable Cranial Perforator recalled | Stryker Instruments Div. of Stryker | Foreign Material | Nationwide |
| Device | CLASS II | Neptune E-sep Blade Electrode recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Other | MI |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |