Synergetics Recalls 25ga Endo Illuminator Due to Faulty Seals
Synergetics Inc is recalling 96 units of 25ga Endo Illuminator devices because faulty seals on the outer pouch could fail, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a seal failure could compromise sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Synergetics Inc is recalling 96 units of 25ga Endo Illuminator devices. The affected products are sterile, single-use, ophthalmic devices with a length of 7.0 ft, packed 12 units per box. The specific lot numbers involved are M260010 and M275520.
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 in the United States and numerous international locations such as 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 Synergetics Inc for further instructions.
The recalled product
- Product
- 25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Category
- Medical Device — Ophthalmic
- Affected units
- 96
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: M260010 and M275520
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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