Synergetics Recalls 29ga Ophthalmic Chandeliers Due to Faulty Seals
Synergetics Inc. is recalling 233 units of 29ga Oshima Dual Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the devices.
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 the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Synergetics Inc. is recalling 233 units of 29ga Oshima Dual Chandeliers. These are single-use, sterile ophthalmic devices manufactured in O'Fallon, Missouri, and distributed worldwide, including in the United States and 22 other countries. The affected units are identified by lot numbers M25990, M263810, M265710, and M271040.
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 sterile integrity of the medical devices.
Healthcare providers and facilities that have received these products should stop using them immediately and contact Synergetics Inc. for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- 29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 233
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 (4)
- Lot number: M25990
- M263810
- M265710
- and M271040
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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