Ethicon Endo-Surgery Inc recalls
Every recall we track for Ethicon Endo-Surgery Inc — 36 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Ethicon Endo-Surgery Inc peaked in 2019 (20); 36 since 2017. 8% rated “stop using now”.
All FDA recall records for Ethicon Endo-Surgery Inc 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 | 1 | 0 | 1 |
| 2018 | 0 | 5 | 4 | 0 | 9 |
| 2019 | 2 | 3 | 13 | 2 | 20 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 2 | 1 | 0 | 3 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 1 | 0 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 1 | 0 | 2 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Ethicon Endo-Surgery Inc 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 Endo-Surgery Inc recalls
13 shown- Lower riskMedical device
Ethicon Endo-Surgery Inc recalls ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product
Ethicon recalls ECHELON LINEAR Cutters Reload 80mm Blue devices shipped unsterilized. These surgical tools may cause infection if used without proper sterilization.
EthiconSep 11, 2025 - Stop using nowMedical device
Ethicon Endo-Surgery Inc recalls Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Ethicon recalls Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row) due to risk of instrument lockout during surgery, which may cause bleeding, delay, or life-threatening hemorrhage.
EthiconApr 22, 2025 - Use cautionMedical device
Ethicon Endo-Surgery Inc recalls ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear
Ethicon recalls ECHELON 45mm staple reloads with GST technology due to risk of incomplete tissue stitching during surgery, potentially requiring additional procedures. Affected units include specific product numbers and lots.
EthiconDec 11, 2023 - Use cautionMedical device
Ethicon Endo-Surgery Inc recalls HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal
Ethicon recalls HARMONICHD 1000i Shears (36cm shaft) due to potential internal component cracking causing continuous activation and burns. Affected units have specific product codes and lot numbers.
EthiconJul 20, 2021 - Lower riskMedical device
Ethicon Endo-Surgery Inc recalls ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments
Ethicon recalls ECHELON FLEX Powered Plus Stapler devices labeled as 60mm but containing 45mm devices. This mislabeling may cause surgical errors. Affected units have specific product codes and expiration dates.
EthiconJun 3, 2021 - Lower riskMedical device
Ethicon Endo-Surgery Inc recalls Ligamax 5 mm Endoscopic Multiple Clip Applier
Ethicon recalls Ligamax 5mm Endoscopic Clip Appliers with potential Tyvek lidding holes that could breach sterility. Affected lots include T93X4R through T94H78. Consumers should check product codes and lot numbers.
EthiconNov 7, 2019 - Use cautionMedical device
Ethicon Endo-Surgery Inc recalls ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
Ethicon recalls ECHELON FLEX ENDOPATH 60mm staplers with specific product codes due to potential staple line failure causing surgery complications. Affected units may require replacement to prevent serious risks.
EthiconOct 3, 2019 - Use cautionMedical device
Ethicon Endo-Surgery Inc recalls Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
Ethicon recalls ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft (NSLX145C) due to reported bleeding risks during surgery. Affected units include all lot numbers sold.
EthiconMay 15, 2019 - Lower riskMedical device
Ethicon Endo-Surgery Inc recalls Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are
Ethicon recalls Straight Intraluminal Staplers (Model SDH25A) due to potential incomplete staple formation. Affected units were sold between February 2023 and March 2024. Consumers should contact Ethicon for details.
EthiconApr 11, 2019 - Use cautionMedical device
Ethicon Endo-Surgery Inc recalls PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler
Ethicon recalls PROXIMATE PPH Hemorrhoidal Circular Staplers with specific product codes due to potential bleeding or soft tissue injury from improper assembly. Affected units include certain lot codes.
EthiconDec 7, 2018 - Use cautionMedical device
Ethicon Endo-Surgery Inc recalls HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN
Ethicon recalls HARMONIC ACE Shears with possible internal component causing unintended activation. Affected models include specific product codes and GTINs. Consumers should contact Ethicon for details.
EthiconMay 3, 2018 - Lower riskMedical device
Ethicon Endo-Surgery Inc recalls 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Ethicon recalls 5mm Endopath Xcel surgical devices with Optiview Technology due to potential surgery prolongation from insufficient lubrication. This recall affects specific lot numbers.
EthiconMar 26, 2018 - Lower riskMedical device
Ethicon Endo-Surgery Inc recalls Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for
Ethicon recalls disposable curved circular staplers that may create staples not meeting height specifications, risking malformed staples during surgery.
EthiconOct 23, 2017
Ethicon Endo-Surgery Inc recall questions
How many recalls has Ethicon Endo-Surgery Inc had?
36 recalls from Ethicon Endo-Surgery Inc are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Ethicon Endo-Surgery Inc recall?
Ethicon Endo-Surgery Inc recalls ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product, dated Sep 11, 2025. Every Ethicon Endo-Surgery Inc recall is listed on this page, newest first.
What should I do if I have a recalled Ethicon Endo-Surgery Inc 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 Endo-Surgery Inc 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.