CLASS II ONGOING Device recall · Reported 26 Jun 2024 · FDA Enforcement Report
Vicryl Plus Antibacterial (polyglactin 910) Suture recalled by Ethicon
Ethicon is recalling Vicryl Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft, distributed nationwide in the US. The recall was initiated on 10 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2145-2024
- FDA event ID
- 94643
- Recalling firm
- Ethicon, Raritan, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 May 2024
- FDA classified
- 14 Jun 2024
- Reported
- 26 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 10 May 2024 | Recall initiated by company | |
| 14 Jun 2024 | Classified by FDA | +35 days |
| 26 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H
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.
Nationwide ArkansasCaliforniaColoradoIllinoisPennsylvaniaPuerto Rico
Questions about this recall
Why was it recalled?
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Which lots are affected?
GTIN: 10705031051546 10705031052147 10705031053038 10705031054370 10705031054394 10705031054677 10705031150492 10705031056329 10705031056725 10705031150119 10705031150287 10705031150447 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 94643This product is part of a recall event; the main page for the event is PDS Plus Antibacterial (polydioxanone) Suture - Intended recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PDS Plus Antibacterial (polydioxanone) Suture - Intended recalled | Ethicon | Sterility | Nationwide | |
| CLASS II | Monocryl (poliglecaprone Suture - Intended for use recalled by Ethicon | Ethicon | Sterility | Nationwide | |
| CLASS II | Vicryl (polyglactin 910) Suture - Indicated for use recalled by Ethicon | Ethicon | Sterility | Nationwide | |
| CLASS II | PDS II (polydioxanone) Suture - Intended for use recalled by Ethicon | Ethicon | Sterility | Nationwide | |
| CLASS II | Monocryl Plus Antibacterial (poliglecaprone Suture recalled by Ethicon | Ethicon | Sterility | Nationwide |
More recalls from Ethicon
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled | Ethicon | Other | Nationwide |
| Device | CLASS II | Perma-hand Silk Suture recalled by Ethicon | Ethicon | Sterility | Nationwide |
| Device | CLASS II | Ethibond Excel Polyester Suture recalled by Ethicon | Ethicon | Sterility | Nationwide |
| Device | CLASS II | Prolene Polypropylene Suture recalled by Ethicon | Ethicon | Sterility | Nationwide |
| Device | CLASS II | Monocryl" (poliglecaprone Suture recalled by Ethicon | Ethicon | Packaging Defects | 45 states |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |