Ethicon, Inc.

Complete recall history across all FDA and CPSC categories — 70 total recalls

Ethicon, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (70)

FDA medical device enforcement actions by Ethicon, Inc.. Showing most recent 50.

Date Product Reason Class
Oct 8, 2024 MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indic... Due a component mix-up in manufacturing, the affected products may contain in... Class II
Sep 25, 2024 Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Produc... Complaints were received regarding needle pull-off and suture degradation. An... Class II
May 10, 2024 MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in ... Issue on a specific packaging machine resulted in a hole in the primary packa... Class II
May 10, 2024 VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in gen... Issue on a specific packaging machine resulted in a hole in the primary packa... Class II
May 10, 2024 PDS II (polydioxanone) Suture - Intended for use in general soft tissue appro... Issue on a specific packaging machine resulted in a hole in the primary packa... Class II
May 10, 2024 VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue ap... Issue on a specific packaging machine resulted in a hole in the primary packa... Class II
May 10, 2024 MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue... Issue on a specific packaging machine resulted in a hole in the primary packa... Class II
May 10, 2024 PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general s... Issue on a specific packaging machine resulted in a hole in the primary packa... Class II
Apr 23, 2024 SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. Some applicator tips from these lots had open seals. Class II
Mar 8, 2024 STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: ... Degraded and unusable upon removal from the foil pouch due to exposed environ... Class II
Mar 31, 2023 PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3... Suture breakage during intra-operative use could result in poor performance o... Class II
Nov 16, 2022 PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product C... knot tensile strengths were observed to be significantly below the minimum kn... Class II
Sep 20, 2022 STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in ... Packages may contain a PS-1 cutting edge needle and not the intended SH taper... Class II
Aug 8, 2022 PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, ... Product may contain the incorrect material which could impact treatment. Class II
Mar 24, 2022 STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product cod... Affected product lots may contain the incorrect needle type/size and suture l... Class II
Jan 4, 2021 Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hol... Product distributed with a red tape as part of the sterile packaging which co... Class II
Oct 23, 2020 PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm The firm is recalling the PROCEED Surgical Mesh device, because it is a steri... Class II
Sep 9, 2020 VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - ... Product in the foil package for VICRYL V960 may not match the foil label and ... Class II
Jun 10, 2020 PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7... Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full she... Class II
Jan 3, 2020 Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The de... Some sutures in the lot may exhibit a small section of braid fraying, which c... Class II
Aug 28, 2019 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429 The product do not meet certain internal testing specifications. Class II
Aug 28, 2019 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402 The product do not meet certain internal testing specifications. Class II
Aug 28, 2019 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201 The product do not meet certain internal testing specifications. Class II
Aug 13, 2019 STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B... The product does not meet certain internal strength testing specifications. Class II
Aug 13, 2019 STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B4... The product does not meet certain internal strength testing specifications. Class II
Apr 19, 2019 ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Pr... Possibility that a suture raw material containing high endotoxin levels was ... Class II
Apr 19, 2019 ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 ... Possibility that a suture raw material containing high endotoxin levels was ... Class II
Mar 12, 2019 VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UN... VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does ... Class II
Mar 12, 2019 VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTU... VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does ... Class II
Mar 12, 2019 PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intende... VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does ... Class II
Dec 18, 2018 PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Pr... The sutures inside the packaging are not the same size or type as indicated o... Class II
Jun 8, 2018 PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18... Products do not meet a tensile strength specification Class II
Jun 8, 2018 PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single... Products do not meet a tensile strength specification Class II
Jun 8, 2018 PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Ar... Products do not meet a tensile strength specification Class II
May 7, 2018 PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PRONOVA SUTURE BLUE 122CM M1.5, D10189 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292 The needle associated with certain suture product codes has the potential to ... Class II
May 7, 2018 PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067 The needle associated with certain suture product codes has the potential to ... Class II

View all 70 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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