VICRYL Sutures VICRYL SUTURE 18”(45CM) 0 VIO VICRYL SUTURE 18”(45CM) 4-0 UND VICRYL SUTURE 18”(45CM) 2-0 VIO…
Medical device recall Z-1134-2019. Published in FDA’s Enforcement Report on Apr 24, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 24, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 550,681 eaches (WW) Total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VICRYL Sutures VICRYL SUTURE 18”(45CM) 0 VIO VICRYL SUTURE 18”(45CM) 4-0 UND VICRYL SUTURE 18”(45CM) 2-0 VIO VICRYL SUTURE 18”(45CM) 0 VIO VICRYL SUTURE 18”(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18”(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18”(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27”(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27”(70CM) 0 VIO
550,681 eaches (WW) Total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Name/Product Code/Lot Numbers: VICRYL SUTURE 18”(45CM) 0 VIO D6043 MKM683, ML5314 VICRYL SUTURE 18”(45CM) 2-0 UND D6226 MJM912 VICRYL SUTURE 18”(45CM) 0 VIO J701D MJ6796 VICRYL SUTURE 18”(45CM) 3-0 VIO J713D MGK411 VICRYL SUTURE…
Every code shown here, 1,207 characters
Product Name/Product Code/Lot Numbers: VICRYL SUTURE 18”(45CM) 0 VIO D6043 MKM683, ML5314 VICRYL SUTURE 18”(45CM) 2-0 UND D6226 MJM912 VICRYL SUTURE 18”(45CM) 0 VIO J701D MJ6796 VICRYL SUTURE 18”(45CM) 3-0 VIO J713D MGK411 VICRYL SUTURE 18”(45CM) 4-0 UND J714D ME5059 MKM907 VICRYL SUTURE 18”(45CM) 2-0 VIO J726D ME5454 VICRYL SUTURE 18”(45CM) 0 VIO J727D MHZ777 VICRYL SUTURE 18”(45CM) 2-0 VIO J739D MGZ324 MHM399 VICRYL CT VIO 8X18IN 0 S/A CT-1 CR 740D ME6539 MJM523 VICRYL SUTURE 18”(45CM) 1 VIO J741D MGZ624 MJ5193 VCL CT UD 8X18IN 2-0 S/A CP-2 CR J762D MJZ094 MLZ026 VCL CT VIO 8X18IN 3-0 S/A SH-1 CR J772D MHZ196 VICRYL CT VIO 8X18IN 2-0 S/A SH CR J775D MLZ864 VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR J839D MG2349 MG2593 MG2666 MG7585 MK2820 VICRYL CT UD 8X18IN 0 S/A CT-1 CR J840D MEK770 MGK812 MJK773 MM6633 VCL CT UD 8X18IN 1 S/A CT-1 CR J841D MEK194 MGK749 MMM998 VCL CT UD 8X18IN 3-0 S/A SH CR J864D MEK524 MGZ556 MHZ379 MHZ475 MJK262 VICRYL SUTURE 18”(45CM) 0 UND JB840 MEK959 MGM275 MGM643 MM6544 VICRYL CT VIO 8X27IN 0 S/A CT-1 CR JJ31G MJK828 VICRYL SUTURE 27”(70CM) 1 UND JJ40G ME6809 VICRYL CT UD 8X27IN 0 S/A CT-1 CR JJ41G ME5281 MGZ466 MGZ563 MHK212 VICRYL SUTURE 27”(70CM) 0 VIO JJ81G MKK878
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 12, 2019.
- FDA classified it on Apr 12, 2019.
- FDA’s Enforcement Report published it on Apr 24, 2019.
- FDA terminated it on Jul 17, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ethicon, Inc., of Somerville, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.