Synergetics Recalls 25ga Aspirating Endo Illuminator Due to Seal Failure
Synergetics is recalling 25ga Aspirating Endo Illuminators because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.
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 is classified as FDA Class II, and the hazard involves a risk of harm (loss of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Synergetics, Inc. is recalling 28 units of 25ga Aspirating Endo Illuminators, lot number M271960. These sterile, single-use ophthalmic devices are manufactured in O'Fallon, Missouri, and are packed 12 units per box. The recall is due to faulty seals on the outer pouch of the double-pouched packaging, which could result in seal failure.
The affected devices 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. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities should stop using the affected devices and contact Synergetics, Inc. for instructions on return or replacement. Consumers should not use these single-use medical devices if they are in their possession.
The recalled product
- Product
- 25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Category
- Medical Device — Ophthalmic
- Affected units
- 28
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 number: M271960
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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