ETHICON Recalls
76 recalls on record · July 4, 2012 to October 1, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 16, 2019Medical DevicesFDA
Ethicon, Inc. recalls STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
Hazard: The product does not meet certain internal strength testing specifications.
June 26, 2019Medical DevicesFDA
Ethicon, Inc. recalls ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBO
Hazard: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
June 26, 2019Medical DevicesFDA
Ethicon, Inc. recalls ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHI
Hazard: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
April 24, 2019Medical DevicesFDA
Ethicon, Inc. recalls PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, inc
Hazard: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
April 24, 2019Medical DevicesFDA
Ethicon, Inc. recalls VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(
Hazard: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
April 24, 2019Medical DevicesFDA
Ethicon, Inc. recalls VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL
Hazard: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
January 23, 2019Medical DevicesFDA
Ethicon, Inc. recalls PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAN
Hazard: The sutures inside the packaging are not the same size or type as indicated on the label.
August 1, 2018Medical DevicesFDA
Ethicon, Inc. recalls PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z5
Hazard: Products do not meet a tensile strength specification
August 1, 2018Medical DevicesFDA
Ethicon, Inc. recalls PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G
Hazard: Products do not meet a tensile strength specification
August 1, 2018Medical DevicesFDA
Ethicon, Inc. recalls PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Prod
Hazard: Products do not meet a tensile strength specification
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PRONOVA SUTURE BLUE 122CM M1.5, D10189
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
July 25, 2018Medical DevicesFDA
Ethicon, Inc. recalls PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
Hazard: 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 tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
May 2, 2018Medical DevicesFDA
Ethicon, Inc. recalls Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fi
Hazard: Products labeled for distribution outside the United States may have been distributed to customers in the United States.