ETHICON M649GRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705031045415), received between Feb 5, 2018 and Sep 4, 2026 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Material Separation” (21 reports).

8 other recalls cover devices cleared under the same FDA submission (K170767, 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613510 ↗
• MalfunctionJan 22, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, IT WAS FOUND THAT HERE HAD BEEN CONTAMINATION INSIDE OF THE PACKAGE. ANOTHER COMPETITIVE PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152112 ↗
• MalfunctionJan 21, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, IT WAS FOUND THAT HERE HAD BEEN CONTAMINATION INSIDE OF THE PACKAGE. ANOTHER COMPETITIVE PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137121 ↗
• MalfunctionJan 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS FOUND THAT THE WIRE WAS DETACHED. NO TROUBLES WERE CAUSED TO THE PATIENT AND THE DOCTOR BECAUSE OF THIS ISSUE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086650 ↗
• MalfunctionOct 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE LIGATION+MECHANICAL VALVE REPLACEMENT OF AORTIC VALVE+MECHANICAL VALVE REPLACEMENT OF MITRAL VALVE (PRESERVING SUBVALVULAR STRUCTURE) +TRICUSPID ANNULOPLASTY+EPICARDIAL ELECTRODE IMPLANTATION+PERICARDIAL FENESTRATION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, STEEL WIRE WAS USED TO FIX STERNUM DURING LEFT ATRIAL APPENDAGE LIGATION+MECHANICAL VALVE REPLACEMENT OF AORTIC VALVE+MECHANICAL VALVE REPLACEMENT OF MITRAL VALVE (PRESERVING SUBVALVULAR STRUCTURE) +TRICUSPID ANNULOPLASTY+EPICARDIAL ELECTRODE IMPLANTATION+PERICARDIAL FENESTRATION SURGERY. IN THE PROCESS OF FIXING STERNUM, WITHOUT FORCED PULLING BY EXTERNAL FORCE AND CUTTING OFF OF STEEL WIRE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE SURGEON IMMEDIATELY STOPPED THE STERNAL FIXATION AND VERIFIED THE POSITION OF STEEL WIRE AND SUTURE NEEDLE TO CONFIRM THAT THERE WAS NO IN VIVO RESIDUE AND NO INJURY TO THE SURGEON; THEN QUICKLY REPLACED ANOTHER ONE AND CHECKED THE CONNECTION FIRMNESS TWICE AND COMPLETED THE FIXATION ACCORDING TO THE SPECIFICATIONS AFTER ADJUSTING THE OPERATION METHOD TO CONTROL THE FORCE. NO ADVERSE PATIENT CONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349324 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. AFFILIATE REFERENCE NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541723 ↗
• MalfunctionMay 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON THAT THERE WAS HAIR WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951457 ↗
• MalfunctionOct 21, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN CARDIOVASCULAR SURGERY, WHEN OPEN THE PACKAGE, THE NEEDLE WAS ALREADY DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494870 ↗
• MalfunctionOct 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE NEEDLES CAME OF THE STEELWIRES. NOT FROM ALL OF THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412736 ↗
• MalfunctionOct 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE NEEDLES CAME OF THE STEELWIRES. NOT FROM ALL OF THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412293 ↗
• MalfunctionMay 21, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. WHEN THE BOX WAS OPENED, ONE PACKAGE WAS ALREADY BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358534 ↗
• MalfunctionMar 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. WHILE SUTURING THE SURGICAL WOUND FOR A FRACTURE PATIENT, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE. THEY CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897716 ↗
• MalfunctionSep 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. IT IS NOT KNOWN WHEN THE EVENT OCCURRED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. WHEN WE SEND THE SAMPLE TO YOU. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686624 ↗
• MalfunctionAug 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. IT IS NOT KNOWN WHEN THE EVENT OCCURRED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546815 ↗
• MalfunctionFeb 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277639 ↗
• MalfunctionJan 6, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY, ON (B)(6) 2022 AND SUTURE WAS USED. WHEN PULLING THE NEEDLE AFTER PENETRATING THE STERNUM, THE NEEDLE CAME OFF IMMEDIATELY FROM THE STEEL JUNCTION. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114325 ↗
• MalfunctionJan 6, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY, ON (B)(6) 2022 AND SUTURE WAS USED. WHEN PULLING THE NEEDLE AFTER PENETRATING THE STERNUM, THE NEEDLE CAME OFF IMMEDIATELY FROM THE STEEL JUNCTION. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114318 ↗
• MalfunctionDec 22, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, WHEN A SCRUB NURSE OPENED THE PACKAGE, IT WAS FOUND THAT THE NEEDLE HAD BEEN DETACHED FROM THE WIRE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDE. UPON EVALUATION OF THE RETURNED DEVICE, AFTER INVESTIGATION OF THE SAMPLE, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039163 ↗
• MalfunctionSep 16, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE AND SUTURE WAS USED. WHEN THE SURGEON GRASPED THE NEEDLE TO USE THE WIRE, THE NEEDLE CAME OFF EASILY DURING INTERRUPTED SUTURING. ANOTHER LOT OF PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442141 ↗
• MalfunctionSep 16, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE AND SUTURE WAS USED. WHEN THE SURGEON GRASPED THE NEEDLE TO USE THE WIRE, THE NEEDLE CAME OFF EASILY DURING INTERRUPTED SUTURING. ANOTHER LOT OF PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442139 ↗
• MalfunctionAug 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED FOR STERNAL CLOSURE. THE NEEDLE WAS DETACHED FROM THE WIRE EASILY DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302509 ↗
• MalfunctionAug 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED FOR STERNAL CLOSURE. THE NEEDLE WAS DETACHED FROM THE WIRE EASILY DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302464 ↗
• MalfunctionApr 5, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN BROKEN ALREADY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018255 ↗
• MalfunctionMar 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2022. AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE, AND IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716870 ↗
• MalfunctionJan 11, 2022Defective Component; Appropriate Device Problem Term/Code Not Available; Defective Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. BEFORE USE ON PATIENT, IT WAS REPORTED THAT THE SUTURE DIAMETER IS DIFFERENT FROM TWO DIFFERENT LOT. ON THE PRODUCT OUTER PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13233235 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170767, 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-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-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-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.