Synergetics Recalls 72 Sterile Ophthalmic Endo Illuminators Due to Seal Failure
Synergetics Inc. is recalling 72 sterile ophthalmic Endo Illuminators because faulty seals on the outer pouch could fail, potentially 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 injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Synergetics Inc. is recalling 72 units of the Endo Illuminator, a sterile, single-use ophthalmic device. The product is a 20-gauge, 7.0-foot length instrument packed 12 units per box. The recall affects Lot number M270130.
The recall is being conducted because faulty seals on the outer pouch of these double-pouched devices could result in seal failure. This defect could potentially compromise the sterile integrity of the medical device.
The affected units were distributed worldwide, including the United States and 22 other countries. Consumers and healthcare providers should stop using the affected devices and contact Synergetics Inc. for further instructions.
The recalled product
- Product
- Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Category
- Medical Device — Ophthalmic
- Affected units
- 72
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: M270130
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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