CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report
Stiff Wide Field Endo Illuminator, Synergetics recalled
Synergetics is recalling Stiff Wide Field Endo Illuminator, Synergetics, inc. length 5 ft, sterile / EO, 21.25PS, distributed nationwide in the US. The recall was initiated on 9 Dec 2013 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-0895-2014
- FDA event ID
- 67147
- Recalling firm
- Synergetics, O Fallon, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2013
- FDA classified
- 30 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 9 Dec 2013 | Recall initiated by company | |
| 30 Jan 2014 | Classified by FDA | +52 days |
| 5 Feb 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
Questions about this recall
Is Stiff Wide Field Endo Illuminator, Synergetics, inc. length 5 ft, sterile / EO, 21.25PS recalled?
Yes. Synergetics recalled Stiff Wide Field Endo Illuminator, Synergetics, inc. length 5 ft, sterile / EO, 21.25PS on 9 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-0895-2014.
Why was it recalled?
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Which lots are affected?
Lot numbers: M260800, M262050, M263140, M264420, and M267440
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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