Ethicon, Inc.: 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

Recall number

Z-1134-2019

Recalling firm

Ethicon, Inc.

Product

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

Status

Terminated

Initiated

2019-03-12

Posted

not on file

Terminated

2020-07-17

Reason

VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

Root cause

Packaging process control

Action

Ethicon notified primary and secondary US consignees via UPS second day between March 12-15,2019. Receipt of the letter confirmed via UPS tracking. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, Middle East. Latin America and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter describes the problem and action to take:Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). Remove the product subject to this voluntary recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. Do not open foil pouches to confirm contents. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall (removal) letter when communicating. Customers are required to return unused impacted VICRYL Suture, VICRYL Plus Suture, PDS Suture and PDS Plus Suture Products subject to this recall (removal) that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall (removal) by July 31, 2019. Questions regarding this recall (removal) or to report any customer complaints,contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266), Monday through Friday, 7:30 AM to 6:30 PM ET. A Business Reply Form (BRF) asked to be completed and returned.

Quantity

550,681 eaches (WW) Total

Distribution

Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE

Lot, serial or model codes

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

510(k) numbers

["K022715"]

PMA numbers

not on file

Product code

GAM

Firm FEI

2210968

Firm city

Somerville

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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