EPA (Environmental Protection Agency)
3 records
fda
55 records
FDA Recall: Ethicon, LLC — Class II
20250212
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 b | Product: PROLENE Polypropylene Suture, REF: EH7...
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FDA Device Recall: PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE S
2025-02-12
Class II — 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 pat...
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FDA Device Recall: ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold
2025-02-12
Class II — 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 pat...
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FDA Recall: Ethicon, Inc. — Class II
20240626
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . | Product: PDS Plus Antibacterial (polydioxanone) Sutur...
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FDA Device Recall: Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product N
2024-11-13
Class II — 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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FDA Device Recall: PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft
2024-06-26
Class II — 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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FDA Device Recall: MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue ap
2024-06-26
Class II — 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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FDA Device Recall: VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue appro
2024-06-26
Class II — 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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FDA Device Recall: PDS II (polydioxanone) Suture - Intended for use in general soft tissue approxim
2024-06-26
Class II — 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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FDA Device Recall: VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in genera
2024-06-26
Class II — 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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FDA Device Recall: PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259
2023-09-27
Class II — Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
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FDA Device Recall: PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(
2023-05-17
Class II — Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
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FDA Device Recall: PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x1
2022-09-28
Class II — Product may contain the incorrect material which could impact treatment.
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FDA Device Recall: STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code:
2022-05-18
Class II — Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
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FDA Device Recall: Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold c
2021-02-10
Class II — Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
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FDA Device Recall: VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Pro
2020-10-28
Class II — Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construc...
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FDA Device Recall: PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983
2020-07-08
Class II — Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
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FDA Device Recall: 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
2020-02-26
Class II — The product do not meet certain internal testing specifications.
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FDA Device Recall: Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The devic
2020-02-12
Class II — Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
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FDA Device Recall: STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401
2019-10-16
Class II — The product does not meet certain internal strength testing specifications.
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FDA Device Recall: ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Pro
2019-06-26
Class II — Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
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FDA Device Recall: PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended f
2019-04-24
Class II — VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
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FDA Device Recall: PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Produ
2019-01-23
Class II — The sutures inside the packaging are not the same size or type as indicated on the label.
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FDA Recall: Ethicon, Inc. — Class II
20180801
Products do not meet a tensile strength specification | Product: PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle P
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FDA Recall: Ethicon, Inc. — Class II
20180801
Products do not meet a tensile strength specification | Product: PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needl
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FDA Recall: Ethicon, Inc. — Class II
20180502
Products labeled for distribution outside the United States may have been distributed to customers in the United States. | Product: Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Cod...
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FDA Recall: Ethicon, Inc. — Class II
20180307
On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 91 | Product: Coated VICRYL RAPIDETM (Polyglactin 91...
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FDA Device Recall: PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed
2018-08-01
Class II — Products do not meet a tensile strength specification
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FDA Device Recall: PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Ar
2018-08-01
Class II — Products do not meet a tensile strength specification
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FDA Device Recall: PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18")
2018-08-01
Class II — Products do not meet a tensile strength specification
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FDA Device Recall: PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
2018-07-25
Class II — The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft ...
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FDA Device Recall: PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
2018-07-25
Class II — The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft ...
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FDA Device Recall: PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
2018-07-25
Class II — The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft ...
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FDA Device Recall: PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
2018-07-25
Class II — The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft ...
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FDA Device Recall: PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
2018-07-25
Class II — The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft ...
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FDA Device Recall: PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
2018-07-25
Class II — The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft ...
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FDA Device Recall: PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
2018-07-25
Class II — The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft ...
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FDA Device Recall: PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
2018-07-25
Class II — The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft ...
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FDA Device Recall: PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
2018-07-25
Class II — The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft ...
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FDA Device Recall: Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Ac
2018-05-02
Class II — Products labeled for distribution outside the United States may have been distributed to customers in the United States.
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FDA Device Recall: PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Singl
2018-04-18
Class II — 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 ex...
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FDA Device Recall: PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Singl
2018-04-18
Class II — 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 ex...
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FDA Device Recall: DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO Sys
2018-03-28
Class II — 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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FDA Device Recall: Coated VICRYL RAPIDETM (Polyglactin 910) Suture
2018-03-07
Class II — 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...
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FDA Recall: Ethicon, Inc. — Class II
20160113
Stability data does not substantiate the labeled two-year shelf life of affected product. | Product: Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE...
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FDA Device Recall: ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip
2016-10-05
Class II — ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are ...
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FDA Device Recall: EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, I
2016-06-22
Class II — Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in the expiration date field on the foil pouch labels of the Fibrin Patch units instead of the...
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FDA Device Recall: Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GY
2016-01-13
Class II — Stability data does not substantiate the labeled two-year shelf life of affected product.
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FDA Device Recall: Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgic
2015-07-01
Class II — Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
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FDA Device Recall: Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon
2014-12-10
Class II — Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.
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FDA Recall: Ethicon, Inc. — Class II
20131218
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal inci | Product: Ethicon Stratafix Symmetric PDS Plus K...
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FDA Device Recall: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC
2013-12-18
Class II — Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
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FDA Device Recall: ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by
2012-11-28
Class I — SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the pack...
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FDA Device Recall: ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somervil
2012-11-28
Class I — SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the pack...
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FDA Device Recall: EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceutic
2012-10-31
Class II — Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer EVICEL; ...
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ny_corps
1 records
NY Corp: ETHICON, INC.
2022-11-03
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: New Jersey
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