CLASS II ONGOING Device recall · Reported 26 Jun 2024 · FDA Enforcement Report
Monocryl Plus Antibacterial (poliglecaprone Suture recalled by Ethicon
Ethicon is recalling Monocryl Plus Antibacterial (poliglecaprone Suture - Intended 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-2149-2024
- 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
- Surgical Instruments
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
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13
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: 10705031046337 10705031121393 10705031121423 10705031121430 10705031046405 10705031046429 10705031046481 10705031046498 10705031046504 10705031046511 10705031121997 10705031148116 10705031122000 10705031122314 10705031122338 10705031046634 10705031046757 10705031046795 10705031046863 Product Code Lot Code MCP266H UAMMCX MCP340H UAMQUZ MCP416H UBMHLB MCP417H UBMLKK MCP426H UAMLDQ UAMRSL UAMRUM UAMRUU UAMRMR UAMRUK UAMRMB MCP427H UAMLRK UAMMCH UAMLTR UAMKTS UAMKQL UAMREE MCP604H UAMLQE MCP936H UBMDQM UBMDPZ UBMEXS UBMQAR UBMEQX UBMKZA UBMLDR MCP945H UAMRKQ MCPB346H UAMQZB
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 | Vicryl Plus Antibacterial (polyglactin 910) 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 Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |