MONOCRYLRecalls & reported problems across all models
Ethicon, LLC · 127 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one MONOCRYL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,308
- Deaths reported
- 0
- Injuries reported
- 166
- Recalls
- 3
We found 127 models of MONOCRYL by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 2,308 adverse event reports in the FDA's MAUDE database, received between Dec 11, 2017 and Sep 30, 2026 — classified as 166 injuries, 2,142 malfunctions.
The most frequently reported specific device problem is “Break” (1,187 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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
MONOCRYL 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.
- Oct 8, 2024Open, Classified
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Z-0487-2025 · 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-2149-2024 · Root cause: Under Investigation by firm · names 6 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-2148-2024 · Root cause: Under Investigation by firm · names 6 of these models · Recall details · FDA record ↗
Most reported MONOCRYL problems
Device problems
- Break1,187
- Material Separation779
- Adverse Event Without Identified Device or Use Problem119
- Material Frayed57
- Detachment Of Device Component47
- Difficult to Open or Remove Packaging Material39
- Component Misassembled38
- Tear, Rip or Hole in Device Packaging30
Patient problems
- No Clinical Signs, Symptoms or Conditions1,439
- No Consequences Or Impact To Patient618
- Wound Dehiscence131
- Unspecified Infection37
- Not Applicable33
- Insufficient Information25
- Pocket Erosion19
- Foreign Body In Patient17
MONOCRYL models
127 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- MONOCRYL MCP426HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall139 reports
- MONOCRYL Y426HSUTURE, ABSORBABLE, SYNTHETIC141 reports
- MONOCRYL MCP936HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall73 reports
- MONOCRYL Y936HSUTURE, ABSORBABLE, SYNTHETIC1 recall66 reports
- MONOCRYL Y923HSUTURE, ABSORBABLE, SYNTHETIC111 reports
- MONOCRYL Y427HSUTURE, ABSORBABLE, SYNTHETIC1 recall53 reports
- MONOCRYL MCP496GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID87 reports
- MONOCRYL Y496GSUTURE, ABSORBABLE, SYNTHETIC86 reports
- MONOCRYL Y943GSUTURE, ABSORBABLE, SYNTHETIC77 reports
- MONOCRYL Y304HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID68 reports
- MONOCRYL Y416HSUTURE, ABSORBABLE, SYNTHETIC1 recall13 reports
- MONOCRYL Y315HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall11 reports
- MONOCRYL Y316HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID61 reports
- MONOCRYL Y935HSUTURE, ABSORBABLE, SYNTHETIC1 recall8 reports
- MONOCRYL Y359HSUTURE, ABSORBABLE, SYNTHETIC1 recall5 reports
- MONOCRYL MCP493GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID54 reports
- MONOCRYL Y432HSUTURE, ABSORBABLE, SYNTHETIC53 reports
- MONOCRYL Y945HSUTURE, ABSORBABLE, SYNTHETIC1 recall3 reports
- MONOCRYL MCP427HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID52 reports
- MONOCRYL Y303HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID52 reports
- MONOCRYL MCP340HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall1 report
- MONOCRYL MCP266HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall0 reports
- MONOCRYL MCP416HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall0 reports
- MONOCRYL MCPB346HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall0 reports
- MONOCRYL Y463GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID50 reports
- MONOCRYL Y494GSUTURE, ABSORBABLE, SYNTHETIC50 reports
- MONOCRYL Y942GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID43 reports
- MONOCRYL Y346HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID41 reports
- MONOCRYL Y497GSUTURE, ABSORBABLE, SYNTHETIC40 reports
- MONOCRYL Y266HSUTURE, ABSORBABLE, SYNTHETIC35 reports
- MONOCRYL Y305HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID33 reports
- MONOCRYL Y433HSUTURE, ABSORBABLE, SYNTHETIC28 reports
- MONOCRYL MCP497GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID27 reports
- MONOCRYL Y417HSUTURE, ABSORBABLE, SYNTHETIC27 reports
- MONOCRYL Y464GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID27 reports
- MONOCRYL MCP316HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID26 reports
- MONOCRYL MCP317HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID26 reports
- MONOCRYL MCP494GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID26 reports
- MONOCRYL Y398HSUTURE, ABSORBABLE, SYNTHETIC26 reports
- MONOCRYL MCP923GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID26 reports
- MONOCRYL Y214HSUTURE, ABSORBABLE, SYNTHETIC25 reports
- MONOCRYL Y493GSUTURE, ABSORBABLE, SYNTHETIC23 reports
- MONOCRYL Y345HSUTURE, ABSORBABLE, SYNTHETIC20 reports
- MONOCRYL Y527HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID20 reports
- MONOCRYL Y358HSUTURE, ABSORBABLE, SYNTHETIC18 reports
- MONOCRYL Y399HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- MONOCRYL MCP943GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID17 reports
- MONOCRYL MCP945HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID16 reports
- MONOCRYL Y732HSUTURE, ABSORBABLE, SYNTHETIC16 reports
- MONOCRYL MCP490GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID14 reports
- MONOCRYL Y605HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- MONOCRYL Y922HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- MONOCRYL MCP942GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- MONOCRYL MCP345HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID12 reports
- MONOCRYL Y523HSUTURE, ABSORBABLE, SYNTHETIC12 reports
- MONOCRYL MCP304HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- MONOCRYL MCP315HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- MONOCRYL Y317HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- MONOCRYL Y415HSUTURE, ABSORBABLE, SYNTHETIC11 reports
- MONOCRYL Y967HSUTURE, ABSORBABLE, SYNTHETIC11 reports
- MONOCRYL MCP922HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID10 reports
- MONOCRYL MCP946HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- MONOCRYL MCP333HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- MONOCRYL MCP358HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- MONOCRYL Y213HSUTURE, ABSORBABLE, SYNTHETIC8 reports
- MONOCRYL Y489GSUTURE, ABSORBABLE, SYNTHETIC8 reports
- MONOCRYL Y495GSUTURE, ABSORBABLE, SYNTHETIC8 reports
- MONOCRYL Y604HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- MONOCRYL MCP935HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- MONOCRYL Y740DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- MONOCRYL Y987HSUTURE, ABSORBABLE, SYNTHETIC7 reports
- MONOCRYL Y215HSUTURE, ABSORBABLE, SYNTHETIC6 reports
- MONOCRYL Y434HSUTURE, ABSORBABLE, SYNTHETIC6 reports
- MONOCRYL Y762HSUTURE, ABSORBABLE, SYNTHETIC6 reports
- MONOCRYL Y845GSUTURE, ABSORBABLE, SYNTHETIC6 reports
- MONOCRYL MCP347HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- MONOCRYL MCP417HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- MONOCRYL MCP987HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- MONOCRYL Y333HSUTURE, ABSORBABLE, SYNTHETIC5 reports
- MONOCRYL Y334HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- MONOCRYL Y352HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- MONOCRYL Y353HSUTURE, ABSORBABLE, SYNTHETIC5 reports
- MONOCRYL Y823GSUTURE, ABSORBABLE, SYNTHETIC5 reports
- MONOCRYL Y943HSUTURE, ABSORBABLE, SYNTHETIC5 reports
- MONOCRYL Y946HSUTURE, ABSORBABLE, SYNTHETIC5 reports
- MONOCRYL Y442HSUTURE, ABSORBABLE, SYNTHETIC5 reports
- MONOCRYL MCP415HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- MONOCRYL Y338HSUTURE, ABSORBABLE, SYNTHETIC4 reports
- MONOCRYL Y339HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- MONOCRYL Y490GSUTURE, ABSORBABLE, SYNTHETIC4 reports
- MONOCRYL Y833GSUTURE, ABSORBABLE, SYNTHETIC4 reports
- MONOCRYL D9568SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- MONOCRYL MCP346HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- MONOCRYL MCP489GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- MONOCRYL MCP523HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- MONOCRYL MCP845GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- MONOCRYL Y340HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- MONOCRYL Y341HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- MONOCRYL Y344HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- MONOCRYL Y739DSUTURE, ABSORBABLE, SYNTHETIC3 reports
Recent MONOCRYL 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
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. It was reported that the suture broke off at the end. The device was returning. There were no patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946225 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932997 ↗MalfunctionSep 24, 2026Break
It was reported a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. Brittle hair strands, breaking during use. Additional information has been requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888515 ↗MalfunctionSep 24, 2026Break
It was reported a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. Brittle hair strands, breaking during use. Additional information has been requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888512 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873905 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873348 ↗MalfunctionSep 21, 2026Break
It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and suture was used. During closing of surgical site, Surgeon and OPERATING ROOM tech informed them, Circulator RN that the tip of a small suture needle 17mm broke off (Monocryl 3-0 PS-2). Surgical Team immediately looked around the operative area and OPERATING ROOM for the tip of needle and did not find it. The tip of the needle is so small (less than 13mm) per policy they do not take x-ray. Since the C-arm that was used in the case was still in the room, Dr had call Radiology Tech and took some magnified C-arm x-rays to see if it is inside the patient's foot/leg. Dr did not see anything on the x-rays. Device is not available for return. There were no patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842611 ↗MalfunctionSep 21, 2026Material Separation
It was reported that a patient underwent an unknown procedure on (B)(6)2026 and suture was used. It was reported that the thread came off needle at the swage during suturing. New sutures were opened to complete procedure. No time delay was reported. Procedure was completed successfully. No fragments, X-rays, etc. No adverse events / consequences reported. No surgical delays reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842354 ↗MalfunctionSep 18, 2026Material Separation
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. It was reported that the needle comes loose from the sutures during operation. There were no patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819496 ↗MalfunctionSep 18, 2026Material Separation
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. It was reported that the needle comes loose from the sutures during operation. There were no patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819495 ↗InjurySep 9, 2026Break
It was reported that a patient underwent a C-section on an unknown date and suture was used. During the procedure, the suture broke and was unable to be located. An X-Ray was done and the patient had be reopened tolocate the suture. Additional information was requested.
Patient problems: Foreign Body In Patient
MAUDE report 50694847 ↗MalfunctionSep 8, 2026Break
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. During the procedure, the needle broke off. No patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667989 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Total Knee Arthroplasty (TKA) procedure on (b)(6) 2026 and a barbed suture was used. Post-op, the patient experienced a wound dehiscence. The surgeon opined the product may have contributed to the wound dehiscence. Additional information was requested.
Patient problems: Wound Dehiscence
MAUDE report 50590497 ↗MalfunctionAug 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50437821 ↗MalfunctionAug 6, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166314 ↗
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
- PDS224 models · 2,635 reports · 10 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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