Ethicon Endo-Surgery Inc
41 recalls on record · Latest: Oct 22, 2025
Ethicon Endo-Surgery Inc Recall Insight
Ethicon Endo-Surgery Inc appears on 41 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.049% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Oct 22, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 41 entries, severity tagging shows 15 critical, 26 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 41 of 41 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (41). The date window on this page runs from Feb 6, 2013 to Oct 22, 2025.
Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface …
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Produc…
Ligamax 5 mm Endoscopic Multiple Clip Applier
ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…
Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…
Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…
Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available…
Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…
Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available…
Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available…
PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have appl…
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The…
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and sid…
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general…
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions wh…
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to pro…
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimall…
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Steri…
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical…
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical…
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band …
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a…
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation …
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopi…
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