Ethicon recalls
Ethicon appears in 77 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 77 |
|---|---|
| Published | 2012-07-04 to 2026-10-21 |
| By agency | FDA Device (77) |
| By classification | Class II (75), Class I (2) |
| By status | terminated (53), ongoing (24) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, US, UT, VA, WA, WI, WV, WY |
Recalls
- PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
FDA Device · Class II · 2026-10-21 · Ethicon
Reason: Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used… - STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Cod…
FDA Device · Class II · 2025-10-01 · Ethicon
Reason: Potential for barb non-engagement. - PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H
FDA Device · Class II · 2025-02-12 · Ethicon
Reason: 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 caus… - ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
FDA Device · Class II · 2025-02-12 · Ethicon
Reason: 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 caus… - PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxima…
FDA Device · Class II · 2025-02-12 · Ethicon
Reason: 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 caus… - MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation…
FDA Device · Class II · 2024-11-27 · Ethicon
Reason: Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length. - Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
FDA Device · Class II · 2024-11-13 · Ethicon
Reason: 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. - PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, i…
FDA Device · Class II · 2024-06-26 · Ethicon
Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . - VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surge…
FDA Device · Class II · 2024-06-26 · Ethicon
Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . - MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an abs…
FDA Device · Class II · 2024-06-26 · Ethicon
Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . - MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is…
FDA Device · Class II · 2024-06-26 · Ethicon
Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . - VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for oph…
FDA Device · Class II · 2024-06-26 · Ethicon
Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . - PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiova…
FDA Device · Class II · 2024-06-26 · Ethicon
Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . - SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979
FDA Device · Class II · 2024-05-29 · Ethicon
Reason: Some applicator tips from these lots had open seals. - STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M…
FDA Device · Class II · 2024-04-24 · Ethicon
Reason: Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility - PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50,…
FDA Device · Class II · 2023-09-27 · Ethicon
Reason: Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. - PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40,…
FDA Device · Class II · 2023-09-27 · Ethicon
Reason: Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. - PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissu…
FDA Device · Class II · 2023-05-17 · Ethicon
Reason: 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 - PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use…
FDA Device · Class II · 2022-12-21 · Ethicon
Reason: 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 - STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures…
FDA Device · Class II · 2022-11-09 · Ethicon
Reason: 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 - PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
FDA Device · Class II · 2022-09-28 · Ethicon
Reason: Product may contain the incorrect material which could impact treatment. - 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 PS-1, product code:…
FDA Device · Class II · 2022-05-18 · Ethicon
Reason: Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up. - Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgica…
FDA Device · Class II · 2021-02-10 · Ethicon
Reason: Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach - PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
FDA Device · Class II · 2020-12-09 · Ethicon
Reason: 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. - VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximati…
FDA Device · Class II · 2020-10-28 · Ethicon
Reason: 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… - PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818…
FDA Device · Class II · 2020-07-08 · Ethicon
Reason: Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years - 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
FDA Device · Class II · 2020-02-26 · Ethicon
Reason: The product do not meet certain internal testing specifications. - 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
FDA Device · Class II · 2020-02-26 · Ethicon
Reason: The product do not meet certain internal testing specifications. - 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
FDA Device · Class II · 2020-02-26 · Ethicon
Reason: The product do not meet certain internal testing specifications. - Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture
FDA Device · Class II · 2020-02-12 · Ethicon
Reason: Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point. - STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
FDA Device · Class II · 2019-10-16 · Ethicon
Reason: The product does not meet certain internal strength testing specifications. - STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
FDA Device · Class II · 2019-10-16 · Ethicon
Reason: The product does not meet certain internal strength testing specifications. - ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is int…
FDA Device · Class II · 2019-06-26 · Ethicon
Reason: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot - ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is inten…
FDA Device · Class II · 2019-06-26 · Ethicon
Reason: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot - VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO…
FDA Device · Class II · 2019-04-24 · Ethicon
Reason: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. - VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS…
FDA Device · Class II · 2019-04-24 · Ethicon
Reason: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. - PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediat…
FDA Device · Class II · 2019-04-24 · Ethicon
Reason: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. - PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated f…
FDA Device · Class II · 2019-01-23 · Ethicon
Reason: The sutures inside the packaging are not the same size or type as indicated on the label. - PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (G…
FDA Device · Class II · 2018-08-01 · Ethicon
Reason: Products do not meet a tensile strength specification - PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 1070503120394…
FDA Device · Class II · 2018-08-01 · Ethicon
Reason: Products do not meet a tensile strength specification - PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061…
FDA Device · Class II · 2018-08-01 · Ethicon
Reason: Products do not meet a tensile strength specification - PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: 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… - PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: 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… - PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: 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… - PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: 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… - PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: 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… - PRONOVA SUTURE BLUE 122CM M1.5, D10189
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: 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… - PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: 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… - PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: 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… - PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
FDA Device · Class II · 2018-07-25 · Ethicon
Reason: 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…