ETHICON, LLC recalls
Every recall we track for ETHICON, LLC — 7 in all, from 2023–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from ETHICON, LLC peaked in 2024 (3); 7 since 2017.
All FDA recall records for ETHICON, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 2 | 0 | 2 |
| 2024 | 0 | 1 | 2 | 0 | 3 |
| 2025 | 0 | 0 | 0 | 1 | 1 |
| 2026 (to date) | 0 | 1 | 0 | 0 | 1 |
What to do if you have a recalled ETHICON, LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All ETHICON, LLC recalls
4 shown- Use cautionMedical device
Ethicon, LLC recalls PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Ethicon recalls silk surgical sutures that may cause delays or wound issues if used improperly. Product code N271H, lot RLBDPJ, expires September 2026. Contact for remedy.
EthiconSep 8, 2026 - UnratedMedical device
ETHICON, LLC recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4)
Ethicon recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device due to potential barb non-engagement. Affected units sold from MO-4 date. Contact Ethicon for details.
EthiconAug 15, 2025 - Use cautionMedical device
Ethicon, LLC recalls PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general
Ethicon recalls specific PROLENE Polypropylene Suture models due to potential open packaging that could breach sterility and cause infections. Affected items include REF: EH7585H, 8706H, 8833H, 8963H, 8935H with expiration dates through August 2029.
EthiconDec 20, 2024 - Lower riskMedical device
ETHICON, LLC recalls PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50,
Ethicon recalls specific PDS Plus Antibacterial sutures due to weak tensile strength. Affected products may break during surgery, risking complications. Consumers should check product numbers and contact Ethicon for details.
EthiconAug 10, 2023
ETHICON, LLC recall questions
How many recalls has ETHICON, LLC had?
7 recalls from ETHICON, LLC are on record with U.S. safety agencies, from 2023–2026.
What is the most recent ETHICON, LLC recall?
Ethicon, LLC recalls PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H, dated Sep 8, 2026. Every ETHICON, LLC recall is listed on this page, newest first.
What should I do if I have a recalled ETHICON, LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new ETHICON, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.