Ethilon 1674H

• EUDAMED Basic UDI-DI B-USMF000013112000064KK registered 4 Aug 2026 Active
• FDA 510(k) K946173 decided 9 Jan 1995 Active
• FDA GUDID UDI-DI D-USMF000013112000064KK listed 1 Sep 2015 Listed

• • Ongoing Z-0284-2027 FDA Not yet classified ·initiated 23 Sep 2026 ·on shared 510(k) K946173

  Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.

• • Ongoing Z-0153-2027 FDA Class II ·initiated 8 Sep 2026 ·on shared 510(k) K946173

  Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.

• • Ongoing Z-1516-2025 FDA Class II ·initiated 7 Mar 2025 ·on shared 510(k) K946173

  Identified curing issues with the silicone during the needles manufacturing process.

• • Ongoing Z-1097-2025 FDA Class II ·initiated 20 Dec 2024 ·on shared 510(k) K946173

  Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

• • Ongoing Z-2486-2020 FDA Class II ·initiated 10 Jun 2020 ·on shared 510(k) K946173

  Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years

• 2 recalls, same reason

  • Terminated Z-1841-2019 FDA Class II ·initiated 19 Apr 2019 ·on shared 510(k) K946173
  • Terminated Z-1842-2019 FDA Class II ·initiated 19 Apr 2019 ·on shared 510(k) K946173

  Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

• • Terminated Z-0747-2019 FDA Class II ·initiated 18 Dec 2018 ·on shared 510(k) K946173

  The sutures inside the packaging are not the same size or type as indicated on the label.

• • Terminated Z-1839-2015 FDA Class II ·initiated 8 May 2015 ·on shared 510(k) K946173

  Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.

• • Terminated Z-0492-2015 FDA Class II ·initiated 17 Oct 2014 ·on shared 510(k) K946173

  Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 1 Sep 2015 Listed FDA GUDID D-USMF000013112000064KK
2. 18 Dec 2018 Recall initiated FDA recalls Z-0747-2019
3. 19 Apr 2019 Recall initiated FDA recalls Z-1841-2019
4. 19 Apr 2019 Recall initiated FDA recalls Z-1842-2019
5. 10 Jun 2020 Recall initiated FDA recalls Z-2486-2020
6. 20 Dec 2024 Recall initiated FDA recalls Z-1097-2025
7. 7 Mar 2025 Recall initiated FDA recalls Z-1516-2025
8. 4 Aug 2026 Registered EUDAMED B-USMF000013112000064KK
9. 8 Sep 2026 Recall initiated FDA recalls Z-0153-2027
10. 23 Sep 2026 Recall initiated FDA recalls Z-0284-2027

3 earlier events are in the sections above.

Trade name

Ethilon

Generic name

Nylon suture, non-bioabsorbable, monofilament

Model / Ref / Catalog

1674H

Primary DI / UDI-DI

D-USMF000013112000064KK EUDAMED

10705031001930 GUDID

Basic UDI-DI

B-USMF000013112000064KK

510(k) Number

K946173 ↗

FDA product code

GAR

EMDN code

H010201010101 Polyamide monofilament with needle

GMDN term

Nylon suture, non-bioabsorbable, monofilament

Device class

Class IIa EUDAMED

Class II GUDID

Regulation number

878.5020

EU registration type

Legacy device (under a directive)

EU market of registration

Belgium

GUDID distribution status

In Commercial Distribution

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-USMF000013112000064KK; FDA GUDID lists 10705031001930), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Nylon suture, non-bioabsorbable, monofilament

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• CARDIONYL® 72020FH23M by PETERS SURGICAL
• TRULON 3G45CY16PR by HEALTHIUM MEDTECH LIMITED

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See all devices from Ethicon Inc. →