ETHICON 1824HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031002654), received between Jan 31, 2018 and Jul 25, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 reports).

8 other recalls cover devices cleared under the same FDA submission (K946173); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NURSE OR MANAGER INFORMED ME THAT TWO NEEDLES SNAPPED OFF THE SUTURES FROM CODE 1824H LOT # 105177. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610764 ↗
• MalfunctionJul 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 27-06-2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NURSE OR MANAGER INFORMED ME THAT TWO NEEDLES SNAPPED OFF THE SUTURES FROM CODE 1824H LOT # 105177. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610747 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEPTOPLASTY IN 2025 AND SUTURE WAS USED. TOWARDS THE MIDDLE OF THE BOX THE NEEDLES WERE COMING OFF OF THE SUTURE. CASE WAS COMPLETED WITH THE SAME BOX. NO PATIENT HARM WAS REPORTED. NOTHING IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154430 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEPTOPLASTY IN 2025 AND SUTURE WAS USED. TOWARDS THE MIDDLE OF THE BOX THE NEEDLES WERE COMING OFF OF THE SUTURE. CASE WAS COMPLETED WITH THE SAME BOX. NO PATIENT HARM WAS REPORTED. NOTHING IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154176 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN RHINOPLASTY PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM #MW5164592, THAT THE SUTURE NEEDLE BROKE OFF THE SUTURE DURING THE INCISION CLOSING OF THE CASE. SURGERY COMPLETED WAS RHINOPLASTY WITH SEPTOPLASTY, SEPTAL PERFORATION REPAIR, COSTAL CARTILAGE GRAFT, PERICHONDRIAL GRAFT, RECTUS FASCIA GRAFT, FAT GRAFT, INFERIOR TURBINATE. INVOLVED SUTURE 4-0 PLAIN GUT ETHICON SUTURE - SC-1 NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434891 ↗
• MalfunctionFeb 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE WHILE SUTURING THROUGH PT'S (PATIENT'S) NASAL CARTILAGE, SURGEON REALIZED THAT THE NEEDLE HAD COME OFF OF THE SUTURE. IMAGING AND ENDOSCOPY WERE REQUIRED TO LOCATE AND REMOVE THE NEEDLE FROM RIGHT TURBINATE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314115 ↗
• MalfunctionJan 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230680 ↗
• MalfunctionJan 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THE NEEDLE WAS STUCK IN THE NASAL CAVITY, BUT WAS RETRIEVED AFTER AN X-RAY WAS DONE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230666 ↗
• MalfunctionAug 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEPTOPLASTY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377262 ↗
• MalfunctionAug 25, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SEPTOPLASTY SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, DRY PACKAGE WAS NOTED WITH EASY BREAKAGE OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364389 ↗
• MalfunctionOct 9, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE HAS PULLED AWAY FROM THE SUTURE AND WAS IN PATIENT NOSE DURING PROCEDURE. THEY LOCATED THE NEEDLE AND REMOVED IT. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9173719 ↗
• MalfunctionJan 31, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ENT PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE CAME OFF OF THE SUTURE WHILE PULLING IT THROUGH TISSUE. PROCEDURE WAS COMPLETED WITH ADDITIONAL SUTURE FROM THE SAME BOX. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7231307 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K946173. One submission often covers many models, so check the product and lot details in each record.

• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
• Z-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
• Z-1841-2019 · Apr 19, 2019 · Terminated
  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 app
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
• Z-1839-2015 · May 8, 2015 · Terminated
  Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
• Z-0492-2015 · Oct 17, 2014 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.