Johnson & Johnson Tray Ring Covers Recalled for Sterility Barrier Breach
Johnson & Johnson Surgical Vision is recalling tray ring covers (Model OM271000) worldwide due to a potential breach in the sterility barrier that could allow contamination.
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: FDA Class II recall involving a surgical medical device with potential loss of sterility—a risk-of-harm condition. No illnesses or injuries have been reported to date.
Plain-English summary
Johnson & Johnson Surgical Vision Inc. is recalling tray ring covers, Model OM271000 (GTIN 05050474520707). These are sterile medical devices used in surgical procedures, marked Rx Only.
The recall affects all lots within expiry due to a potential breach in the sterility barrier. Compromised sterility could result in contamination and expose patients to infection during surgical procedures.
The affected products have been distributed worldwide. In the United States, distribution includes Alabama, Arizona, Arkansas, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Maryland, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, Nevada, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington, and Wisconsin. International distribution included Chile, Indonesia, India, Japan, Malaysia, Philippines, and Taiwan.
The recalled product
- Product
- TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
- Manufacturer
- Johnson & Johnson Surgical Vision Inc
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)
- All Lots within Expiry: GTIN:05050474520707
Distribution
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