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 1, 2025Medical DevicesFDA
ETHICON, LLC recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/
Hazard: Potential for barb non-engagement.
February 12, 2025Medical DevicesFDA
Ethicon, LLC recalls ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Hazard: 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.
February 12, 2025Medical DevicesFDA
Ethicon, LLC recalls PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tiss
Hazard: 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.
February 12, 2025Medical DevicesFDA
Ethicon, LLC recalls PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general so
Hazard: 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.
November 27, 2024Medical DevicesFDA
ETHICON, INC. recalls MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approxi
Hazard: Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
November 13, 2024Medical DevicesFDA
Ethicon, Inc. recalls Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Hazard: 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.
June 26, 2024Medical DevicesFDA
Ethicon, Inc. recalls MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or li
Hazard: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
June 26, 2024Medical DevicesFDA
Ethicon, Inc. recalls MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an abs
Hazard: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
June 26, 2024Medical DevicesFDA
Ethicon, Inc. recalls PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in
Hazard: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
June 26, 2024Medical DevicesFDA
Ethicon, Inc. recalls PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardi
Hazard: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
June 26, 2024Medical DevicesFDA
Ethicon, Inc. recalls VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligat
Hazard: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
June 26, 2024Medical DevicesFDA
Ethicon, Inc. recalls VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use
Hazard: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
May 29, 2024Medical DevicesFDA
Ethicon, Inc. recalls SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Hazard: Some applicator tips from these lots had open seals.
April 24, 2024Medical DevicesFDA
Ethicon, Inc. recalls STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12I
Hazard: Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
September 27, 2023Medical DevicesFDA
ETHICON, LLC recalls PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z
Hazard: Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
September 27, 2023Medical DevicesFDA
ETHICON, LLC recalls PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PD
Hazard: Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
May 17, 2023Medical DevicesFDA
Ethicon, Inc. recalls PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in
Hazard: 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
December 21, 2022Medical DevicesFDA
Ethicon, Inc. recalls PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approx
Hazard: knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
November 9, 2022Medical DevicesFDA
Ethicon, Inc. recalls STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of
Hazard: Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
September 28, 2022Medical DevicesFDA
Ethicon, Inc. recalls PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Hazard: Product may contain the incorrect material which could impact treatment.
May 18, 2022Medical DevicesFDA
Ethicon, Inc. recalls STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A P
Hazard: Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
February 10, 2021Medical DevicesFDA
Ethicon, Inc. recalls Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of
Hazard: Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
December 9, 2020Medical DevicesFDA
Ethicon, Inc. recalls PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Hazard: The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
October 28, 2020Medical DevicesFDA
Ethicon, Inc. recalls VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft
Hazard: 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 construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles
July 8, 2020Medical DevicesFDA
Ethicon, Inc. recalls PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W
Hazard: Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
February 26, 2020Medical DevicesFDA
Ethicon, Inc. recalls 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
Hazard: The product do not meet certain internal testing specifications.
February 26, 2020Medical DevicesFDA
Ethicon, Inc. recalls 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
Hazard: The product do not meet certain internal testing specifications.
February 26, 2020Medical DevicesFDA
Ethicon, Inc. recalls 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
Hazard: The product do not meet certain internal testing specifications.
February 12, 2020Medical DevicesFDA
Ethicon, Inc. recalls Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surg
Hazard: Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
October 16, 2019Medical DevicesFDA
Ethicon, Inc. recalls STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Hazard: The product does not meet certain internal strength testing specifications.