FDA (Devices) recall action 82539

Ethicon Endo-Surgery Inc recalled 12 products on 2019-05-22

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2019-05-22
Critical: 2
Units: 5,215,368

Why these products were recalled

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–12 of 12

SevereFDA (Devices)··2019-05-22
Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect
Ethicon Endo-Surgery Inc is recalling 434,614 Straight Intraluminal Staplers (Model SDH29A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the…
Category
Distribution
0 states
SevereFDA (Devices)··2019-05-22
Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect
Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH33A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the…
Category
Distribution
0 states
SevereFDA (Devices)··2019-05-22
Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery is recalling 434,614 Curved Intraluminal Staplers (Model CDH33A) because they may have an insufficient firing stroke to break the washer and form staples.
Product
Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the…
Category
Distribution
0 states
SevereFDA (Devices)··2019-05-22
Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers
Ethicon Endo-Surgery is recalling 434,614 Endoscopic Curved Intraluminal Staplers because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue…
Category
Distribution
0 states
SevereFDA (Devices)··2019-05-22
Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery is recalling Curved Intraluminal Staplers, Model CDH25A, because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the…
Category
Distribution
0 states
CriticalFDA (Devices)··2019-05-22
Ethicon Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH21A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the…
Category
Distribution
0 states
SevereFDA (Devices)··2019-05-22
Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery Inc is recalling Curved Intraluminal Staplers, Model CDH21A, because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the…
Category
Distribution
0 states
SevereFDA (Devices)··2019-05-22
Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers
Ethicon Endo-Surgery is recalling 434,614 Endoscopic Curved Intraluminal Staplers (Model ECS25A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue…
Category
Distribution
0 states
SevereFDA (Devices)··2019-05-22
Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect
Ethicon Endo-Surgery Inc is recalling 434,614 Straight Intraluminal Staplers (Model SDH25A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the…
Category
Distribution
0 states
SevereFDA (Devices)··2019-05-22
Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery Inc is recalling 434,614 Curved Intraluminal Staplers (Model CDH29A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the…
Category
Distribution
0 states
SevereFDA (Devices)··2019-05-22
Ethicon Endo-Surgery Recalls 33 mm Endoscopic Curved Intraluminal Staplers
Ethicon Endo-Surgery Inc is recalling 434,614 Model ECS33A staplers worldwide because they may have an insufficient firing stroke to break the washer and form staples.
Product
Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue…
Category
Distribution
0 states
CriticalFDA (Devices)··2019-05-22
Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers
Ethicon Endo-Surgery is recalling 434,614 endoscopic curved intraluminal staplers because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue…
Category
Distribution
0 states