PDSRecalls & reported problems across all models
Ethicon, LLC · 224 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
7 open recalls name 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
- 2,635
- Deaths reported
- 1
- Injuries reported
- 170
- Recalls
- 10
We found 224 models of PDS by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 2,635 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2017 and Sep 30, 2026 — classified as 1 death, 170 injuries, 2,464 malfunctions.
The most frequently reported specific device problem is “Break” (1,694 reports).
10 FDA recall records name at least one of these models by its device identifier, 7 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.
- Mar 7, 2025Open, Classified
Identified curing issues with the silicone during the needles manufacturing process.
Z-1514-2025 · Root cause: Process control · Recall details · FDA record ↗
- Mar 7, 2025Open, Classified
Identified curing issues with the silicone during the needles manufacturing process.
Z-1513-2025 · Root cause: Process control · Recall details · FDA record ↗
- May 10, 2024Open, Classified
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Z-2147-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- May 10, 2024Open, Classified
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Z-2146-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- 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 22 of these models · Recall details · FDA record ↗
- 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-2616-2023 · Root cause: Under Investigation by firm · names 8 of these models · Recall details · FDA record ↗
- Nov 16, 2022Open, Classified
knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
Z-0480-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 10, 2018Terminated
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Z-1340-2018 · Root cause: Process control · Recall details · FDA record ↗
- Jan 10, 2018Terminated
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Z-1339-2018 · Root cause: Process control · Recall details · FDA record ↗
- Jan 10, 2018Terminated
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Z-1338-2018 · Root cause: Process control · Recall details · FDA record ↗
Most reported PDS problems
Device problems
- Break1,694
- Material Separation707
- Adverse Event Without Identified Device or Use Problem104
- Component Misassembled28
- Device Contaminated During Manufacture or Shipping25
- Device Markings/Labelling Problem25
- Detachment Of Device Component24
- Defective Component20
Patient problems
- No Clinical Signs, Symptoms or Conditions1,802
- No Consequences Or Impact To Patient591
- Wound Dehiscence107
- Unspecified Infection47
- Insufficient Information35
- Not Applicable29
- Foreign Body In Patient27
- Pain23
PDS models
224 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- PDS Z494GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall159 reports
- PDS Z340HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall66 reports
- PDS PDP304HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall61 reports
- PDS Z493GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall56 reports
- PDS Z496GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall47 reports
- PDS Z316HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE91 reports
- PDS PDP259HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall30 reports
- PDS Z149HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall25 reports
- PDS PDP346HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall22 reports
- PDS Z464HSuture, surgical, absorbable, polydioxanone70 reports
- PDS PDP489GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall19 reports
- PDS Z304HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE68 reports
- PDS Z127HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall17 reports
- PDS Z507GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall17 reports
- PDS Z497GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall16 reports
- PDS Z503GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall12 reports
- PDS Z259HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall8 reports
- PDS Z489GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall7 reports
- PDS Z509GSuture, surgical, absorbable, polydioxanone1 recall7 reports
- PDS PDP497GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall6 reports
- PDS Z495GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall6 reports
- PDS D6261SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall5 reports
- PDS D8790SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall4 reports
- PDS PDP341HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall4 reports
- PDS Z320HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall4 reports
- PDS PDP316HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE53 reports
- PDS Z513GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE53 reports
- PDS PDPB740DSuture, surgical, absorbable, polydioxanone53 reports
- PDS PDP127HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall2 reports
- PDS PDPB346SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall2 reports
- PDS PDP442HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall1 report
- PDS Z516GSuture, surgical, absorbable, polydioxanone1 recall1 report
- PDS Z844GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall1 report
- PDS D6776SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS D9297SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS D9632SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS PDP416HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS PDP441HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS PDP662HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS PDP663HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS PDP695HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS Z311HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE50 reports
- PDS Z504GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS Z663HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS Z683GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS Z833GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS D10065SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS D10085SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- PDS Z451GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE46 reports
- PDS Z339HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE45 reports
- PDS D10147SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE44 reports
- PDS PDP513GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE43 reports
- PDS PDP317HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE40 reports
- PDS PDP311HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE37 reports
- PDS Z317HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE35 reports
- PDS Z310HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death34 reports
- PDS Z334HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE34 reports
- PDS Z990GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE32 reports
- PDS PDP771DSuture, surgical, absorbable, polydioxanone30 reports
- PDS PDP149HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE28 reports
- PDS Z398HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE28 reports
- PDS Z303HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE27 reports
- PDS PDP494GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE26 reports
- PDS Z969HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE26 reports
- PDS PDP305HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE24 reports
- PDS PDP990GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE24 reports
- PDS Z346HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE24 reports
- PDS PDP340HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE23 reports
- PDS Z333HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE23 reports
- PDS PDP148HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE21 reports
- PDS PDP310HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE19 reports
- PDS Z315HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE19 reports
- PDS Z466HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE19 reports
- PDS Z924HSuture, surgical, absorbable, polydioxanone19 reports
- PDS PDP6659HSuture, surgical, absorbable, polydioxanone19 reports
- PDS Z148HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE18 reports
- PDS ZB740SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE18 reports
- PDS D7725SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE17 reports
- PDS Z452GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE17 reports
- PDS PDP339HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE16 reports
- PDS Z135HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE16 reports
- PDS PDP509GSuture, surgical, absorbable, polydioxanone16 reports
- PDS PDP467HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE15 reports
- PDS Z126HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE15 reports
- PDS PDP303HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE14 reports
- PDS PDP333HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE14 reports
- PDS PDP507GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE14 reports
- PDS PDPB340SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE14 reports
- PDS PDP496GSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE13 reports
- PDS Z305HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE13 reports
- PDS Z508GSuture, surgical, absorbable, polydioxanone13 reports
- PDS PDP358TSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE12 reports
- PDS Z358TSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE12 reports
- PDS Z371TSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE12 reports
- PDS PDP334HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE11 reports
- PDS Z117HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE11 reports
- PDS PDPB765DSuture, surgical, absorbable, polydioxanone11 reports
- PDS D7190SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE10 reports
- PDS D8350SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE10 reports
- PDS PDP969HSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE10 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.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949949 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947876 ↗MalfunctionSep 30, 2026Product Quality Problem
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The surgeon said that the ligation felt different than usual, and the ligation strength seemed weaker. The sensation of the ligation appears to be slightly softer than normal. The product in question was discarded after one pack was used. It was not a control release needle. Another product was used to complete the case. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946295 ↗InjurySep 29, 2026Break
Patient problems: Foreign Body In Patient
MAUDE report 50937774 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932443 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932241 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932240 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932239 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919152 ↗MalfunctionSep 28, 2026Material Separation
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The thread and needle separated on the suture. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918983 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918926 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916959 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916040 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915500 ↗MalfunctionSep 28, 2026Break
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The sutures were faulty, snapping every time using pressure to utilize the suture itself. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915467 ↗
Other Ethicon, LLC products
- Coated VICRYL350 models · 8,555 reports · 1 recall
- STRATAFIX181 models · 7,673 reports · 7 recalls
- PROLENE358 models · 7,292 reports · 2 recalls
- MONOCRYL127 models · 2,308 reports · 3 recalls
- ETHILON133 models · 1,680 reports · 1 recall
- DERMABOND PRINEO4 models · 1,099 reports
- ETHIBOND EXCEL134 models · 921 reports · 2 recalls
- PERMA-HAND77 models · 664 reports · 1 recall
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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