Synergetics Recalls 23ga Wide Field Endo Illuminator Due to Seal Failure
Synergetics Inc is recalling 568 units of 23ga Wide Field Endo Illuminators because faulty seals on the outer pouch could result in seal failure.
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 no injuries or illnesses have been reported in the source text.
Plain-English summary
Synergetics Inc is recalling 568 units of 23ga Wide Field Endo Illuminators. The affected devices are sterile, single-use, ophthalmic instruments with a length of 7.5 feet, packed 12 units per box. The specific lot numbers involved are M261310, M262650, M263630, M265960, and M268970.
The recall was initiated 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 medical devices.
The affected units were distributed worldwide, including nationwide in the United States and in 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. Healthcare facilities and distributors should stop using the affected lots and contact Synergetics Inc for further instructions.
The recalled product
- Product
- 23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 568
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: M261310
- M262650
- M263630
- M265960
- and M268970
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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