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 |
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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