Ethicon Recalls
108 recalls on record in the United States
Ethicon, Inc. recalls PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Pl
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
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Ethicon, Inc. recalls PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Pl
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
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Ethicon, Inc. recalls PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PL
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
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Ethicon, Inc. recalls DERMABOND" PRINEO" Skin Closure System Product Usage: DE
Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.
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Ethicon, Inc. recalls Coated VICRYL RAPIDETM (Polyglactin 910) Suture
On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing.
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Ethicon Endo-Surgery Inc recalls Disposable Curved Circular Staplers Product Usage: Stapl
There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
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Ethicon Endo-Surgery Inc recalls Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VAS
There is a risk that the pinion gear in the device could fail under extreme use cases.
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Ethicon Endo-Surgery Inc recalls ECHELON LINEAR Cutters Reload 80 mm Blue, intended for trans
The devices were shipped unsterilized.
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ETHICON, LLC recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Cont
Potential for barb non-engagement.
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Ethicon Endo-Surgery Inc recalls Endopath Echelon Vascular White Reload for Advanced Placemen
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
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Ethicon Endo Surgery, LLC recalls PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Identified curing issues with the silicone during the needles manufacturing process.
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Ethicon Endo Surgery, LLC recalls PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Identified curing issues with the silicone during the needles manufacturing process.
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Ethicon Endo Surgery, LLC recalls ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Identified curing issues with the silicone during the needles manufacturing process.
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Ethicon Endo Surgery, LLC recalls PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
Identified curing issues with the silicone during the needles manufacturing process.
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Ethicon, LLC recalls PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 89
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
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Ethicon, LLC recalls ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, E
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
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Ethicon, LLC recalls PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perm
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
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ETHICON, INC. recalls MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL"
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
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Ethicon, Inc. recalls Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
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Ethicon Sarl, a Johnson & Johnson Company recalls SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 196
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
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Ethicon Sarl, a Johnson & Johnson Company recalls SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 196
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
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Ethicon, Inc. recalls PDS Plus Antibacterial (polydioxanone) Suture - Intended for
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
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Ethicon, Inc. recalls MONOCRYL (poliglecaprone 25) Suture - Intended for use in ge
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
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Ethicon, Inc. recalls VICRYL (polyglactin 910) Suture - Indicated for use in gener
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
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Ethicon, Inc. recalls PDS II (polydioxanone) Suture - Intended for use in general
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
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Ethicon, Inc. recalls VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicat
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
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Ethicon, Inc. recalls MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Int
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
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Ethicon, Inc. recalls SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Some applicator tips from these lots had open seals.
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Ethicon, Inc. recalls STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
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Ethicon Endo-Surgery Inc recalls ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLO
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
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Showing 30 of 108 recalls. See all →