Synergetics Recalls 23ga Aspirating Endo Illuminator Due to Seal Failure
Synergetics is recalling 43 units of 23ga Aspirating 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 injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Synergetics, Inc. is recalling 43 units of the 23ga Aspirating Endo Illuminator, a sterile, single-use ophthalmic device. The product is manufactured in O'Fallon, Missouri, and is packed 12 units per box. The specific lot numbers involved are M265310 and M262070.
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 device.
The affected units were distributed nationwide in the United States and internationally to 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. Users should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- 23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Category
- Medical Device — Ophthalmic
- Affected units
- 43
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 (1)
- Lot numbers: M265310 and M262070
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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