PDSRecalls & reported problems across all models
Ethicon Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PDS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 6 models of PDS by Ethicon Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2018 and Mar 18, 2025 — classified as 6 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Break” (28 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PDS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 10, 2023Open, Classified
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Z-2617-2023 · Root cause: Under Investigation by firm · names 6 of these models · Recall details · FDA record ↗
Most reported PDS problems
Device problems
- Break28
- Material Separation8
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient5
- Erythema4
- Itching Sensation4
- Pain4
- Skin Inflammation/ Irritation4
- Swelling/ Edema4
- Insufficient Information2
PDS models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PDS Z423HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall12 reports
- PDS Z442HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall12 reports
- PDS Z422HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall11 reports
- PDS Z443HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall3 reports
- PDS Z416HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall1 report
- PDS Z421HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
Recent PDS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WITH USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21633279 ↗MalfunctionAug 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY SURGEON THAT EVERY SUTURE WE¿VE USED FROM THIS BOX HAS BROKEN WHILE TYING THE KNOT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20107115 ↗MalfunctionAug 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY SURGEON THAT EVERY SUTURE WE¿VE USED FROM THIS BOX HAS BROKEN WHILE TYING THE KNOT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20107085 ↗MalfunctionAug 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY SURGEON THAT EVERY SUTURE WE¿VE USED FROM THIS BOX HAS BROKEN WHILE TYING THE KNOT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20107077 ↗MalfunctionAug 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY SURGEON THAT EVERY SUTURE WE¿VE USED FROM THIS BOX HAS BROKEN WHILE TYING THE KNOT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20107051 ↗MalfunctionAug 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY SURGEON THAT EVERY SUTURE WE¿VE USED FROM THIS BOX HAS BROKEN WHILE TYING THE KNOT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20107039 ↗MalfunctionAug 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY SURGEON THAT EVERY SUTURE WE¿VE USED FROM THIS BOX HAS BROKEN WHILE TYING THE KNOT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20106998 ↗MalfunctionAug 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY SURGEON THAT EVERY SUTURE WE¿VE USED FROM THIS BOX HAS BROKEN WHILE TYING THE KNOT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20106985 ↗MalfunctionAug 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY SURGEON THAT EVERY SUTURE WE¿VE USED FROM THIS BOX HAS BROKEN WHILE TYING THE KNOT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20106974 ↗MalfunctionAug 30, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY SURGEON THAT EVERY SUTURE WE¿VE USED FROM THIS BOX HAS BROKEN WHILE TYING THE KNOT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20106971 ↗MalfunctionJun 5, 2024Break; Material Separation; Break; 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, DURING AN UNKNOWN SURGERY, WHEN PASSING THE TISSUE BY THE NEEDLE, IT WAS NOTICED THAT THE SUTURE WAS COME OFF ALREADY. 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 19468379 ↗MalfunctionJun 4, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE SWAGE PART. THE OPERATION TIME WAS NOT EXTENDED. 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 19463643 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE. THE SURGEON WAS USING A FULL LENGTH AND TYING A KNOT WHEN IT BROKE AND THEN SHE PULLING TISSUE TOGETHER NEAR AREOLA AND IT BROKE. THERE WERE NO PATIENT CONSEQUENCES WAS REPORTED. UNKNOWN IF THE DEVICE WAS RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380840 ↗MalfunctionMay 23, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE AND THE SUTURE POPPED OFF AT THE NEEDLE THE SURGEON WAS USING A FULL LENGTH AND TYING A KNOT WHEN IT BROKE AND THEN SHE PULLING TISSUE TOGETHER NEAR AREOLA AND IT BROKE. THERE WERE NO PATIENT CONSEQUENCES WAS REPORTED. UNKNOWN IF THE DEVICE WAS RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380837 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE AND TYING A KNOT WHEN IT BROKE AND THEN SHE PULLING TISSUE TOGETHER NEAR AREOLA AND IT BROKE. THERE WERE NO PATIENT CONSEQUENCES WAS REPORTED. UNKNOWN IF THE DEVICE WAS RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380836 ↗
Other Ethicon Inc. products
All Ethicon Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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