Synergetics Recalls Stiff 25ga Wide Field Endo Illuminator Due to Seal Failure
Synergetics Inc is recalling specific lots of Stiff 25ga Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where seal failure could compromise sterility, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Synergetics Inc is recalling 507 units of Stiff 25ga Wide Field Endo Illuminators. The affected devices are sterile, single-use, ophthalmic instruments manufactured in O'Fallon, Missouri, and distributed worldwide, including in the United States and 22 other countries. The recall involves specific lot numbers: M260800, M262050, M263140, M264420, and M267440.
The recall is being conducted because faulty seals on the outer pouch of these double-pouched devices could result in seal failure. This defect poses a risk to the sterility of the instruments, which are intended for use in ophthalmic procedures.
Healthcare facilities and distributors should stop using the affected devices and contact Synergetics Inc for further instructions on the recall process.
The recalled product
- Product
- 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.
- Manufacturer
- Synergetics Inc
- Affected units
- 507
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot numbers: M260800
- M262050
- M263140
- M264420
- and M267440
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by Synergetics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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