Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H
Why it was recalled
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
UDI-DI: N/A PRODUCT CODE PRODUCT LOTS J214H UAMPJQ J218H UBMJSK J258H UBMHSJ J268H UBMLPP J269H UAMMAH UAMRMU J327H UAMPEP J344H UBMHRU J345H UAMJPK UAMPKD J370H UAMMJT J416H UAMRSJ UAMRHB J417H UAMLMX J426H UAMQRQ UBMCAC UBMCML UBMCRD J427H UAMRPR J458H UAMQRT J493H UAMMKE J603H TPMBSX UAMLXC UAMMBQ J699H UAMQME J936H UAMMSL J978H UAMKBD UAMHTE
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
Recall record
- Recalling firm
- Ethicon, Inc.
- Product type
- Devices
- Recall number
- Z-2144-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Raritan, NJ
- Recall initiated
- 2024-05-10
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2144-2024 · Source: openFDA enforcement.