Z-1841-2019Class II

ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1

Name: Z-1841-2019 ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1
Creator: Ethicon, Inc.
Published: 2019-04-19
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2019-04-19 / Terminated / root cause: manufacturing process

FDA source

Ethicon, Inc. began a recall of ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in... on 2019-04-19. FDA classified it as Class II and gives the reason as "Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1841-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-19
Posted: 2019-06-19
Terminated: 2021-02-05
Recalling firm: Ethicon, Inc
Product: ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
Product code: GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Reason for recall: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Ethicon notified primary and secondary US consignees by telephone on 4/19/19 and follow-up letter dated April 24, 2019 stating reason for recall, health risk and action to take: examine inventory, remove product for return. Complete the Business Reply Form (BRF) to Stericycle at 1-844-721-3045 or [email protected]. Questions regarding this action or to report any customer complaints, please contact your Ethicon sales representative or contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.
Quantity in commerce: 1296 eaches
Distribution: Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
Product codes and lots: Lot Code: PBQ426

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1841-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1841-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-18
Z-1842-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-18

Product code GAQ

K946173Class IIStainless Steel, Gut, Poly (Glycolide/l-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and SilkETHICON, Inc. / cleared 1995-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)