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VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"...

FDA Device Recall #Z-1134-2019 — Class II — March 12, 2019

Recall Summary

Recall Number Z-1134-2019
Classification Class II — Moderate risk
Date Initiated March 12, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ethicon, Inc.
Location Somerville, NJ
Product Type Devices
Quantity 550,681 eaches (WW) Total

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Lot / Code Information

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

Other Recalls from Ethicon, Inc.

Recall # Classification Product Date
Z-0487-2025 Class II MONOCRYL" (poliglecaprone 25) Suture REF Y936H ... Oct 8, 2024
Z-0319-2025 Class II Coated VICRYL Polyglactin 910 Suture VIO 36IN(9... Sep 25, 2024
Z-2148-2024 Class II MONOCRYL (poliglecaprone 25) Suture - Intended ... May 10, 2024
Z-2144-2024 Class II VICRYL (polyglactin 910) Suture - Indicated for... May 10, 2024
Z-2147-2024 Class II PDS Plus Antibacterial (polydioxanone) Suture -... May 10, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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