Recall archive / FDA device enforcement
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an ... — FDA record Z-2148-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 10, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
- Reason
- Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Classification
- Class II
- Recalling firm
- Ethicon, Inc.
- Quantity
- 306000 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2148-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN: GTIN 10705031058729 10705031058897 10705031059047 10705031059092 10705031059122 30705031059133 10705031112674 10705031059146 10705031059153 10705031059245 10705031059894 10705031059917 10705031059962 PRODUCT CODE PRODUCT LOTS Y315H UAMQCX Y345H UBMCAJ Y359H UBMHQS Y398H UAMLMU UAMPJB UAMMXQ UBMJPB UBMQQR Y416H UAMLQM UAMLKM UAMRMZ Y417H UCMEDU Y426H UAMKCL UAMKHE UAMPQS UBMJTE Y427H UAMLXX UAMMJR UAMPSC Y935H UBMCAA UBMDKJ UBMDKC UBMHDD Y936H UBMJQM Y945H UAMKCD |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 26, 2024
- Recall initiation date
- May 10, 2024
- Center classification date
- Jun 14, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.