ETHICON ENDO-SURGERY, INC. — FDA Facility Profile
ETHICON ENDO-SURGERY, INC. is an FDA-registered facility (FEI 1527736) located in Cincinnati, OH, US. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Aug 4, 2023: No Action Indicated (NAI)
- Inspections on record
- 8 (1 VAI, 7 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 26, latest Sep 11, 2025
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 4, 2023 | No Action Indicated (NAI) | No citations listed |
| Aug 15, 2019 | No Action Indicated (NAI) | No citations listed |
| May 26, 2017 | No Action Indicated (NAI) | No citations listed |
| Jun 5, 2015 | No Action Indicated (NAI) | No citations listed |
| Jun 11, 2014 | No Action Indicated (NAI) | No citations listed |
| Dec 8, 2011 | No Action Indicated (NAI) | No citations listed |
| Aug 19, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 17, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 11, 2025 | Class II | Z-0147-2026 | ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or… The devices were shipped unsterilized. |
| Apr 22, 2025 | Class I | Z-1746-2025 | Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product… Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If… |
| Dec 11, 2023 | Class II | Z-0834-2024 | ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath… There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to… |
| Jul 20, 2021 | Class II | Z-2355-2021 | HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when… and 1 more product An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the… |
| Jun 3, 2021 | Class II | Z-2326-2021 | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of… Mislabeled: Labeled on the package as 60mm contains 45mm devices |
| Nov 7, 2019 | Class II | Z-0656-2020 | Ligamax 5 mm Endoscopic Multiple Clip Applier A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a… |
| Oct 3, 2019 | Class I | Z-0200-2020 | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A and 3 more products The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed… |
| May 15, 2019 | Class II | Z-1888-2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft
PRODUCT CODE: NSLX125C and 2 more products Observed reported incidence rate for harm associated with intraoperative bleeding |
| Apr 11, 2019 | Class I | Z-1267-2019 | Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A
The Ethicon Endo-Surgery… and 11 more products The staplers may have an insufficient firing stroke to break the washer and completely form staples. |
| Dec 7, 2018 | Class II | Z-0695-2019 | PROXIMATE¿ HCS Hemorrhoidal Circular Stapler
Product Code: PPH01
PPH01: The… and 1 more product Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use… |
Facility details
- Company
- Ethicon Endo-Surgery Inc
- Location
- Cincinnati, OH (US)
- Source
- device