ETHICON, INC. recalls
Every recall we track for ETHICON, INC. — 59 in all, from 2017–2024 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from ETHICON, INC. dropped to zero in 2025 (0, down from 10 in 2024). 2% rated “stop using now”.
All FDA recall records for ETHICON, INC. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 2 | 0 | 2 |
| 2018 | 0 | 16 | 10 | 1 | 27 |
| 2019 | 0 | 0 | 4 | 6 | 10 |
| 2020 | 0 | 0 | 4 | 0 | 4 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 1 | 1 | 2 | 0 | 4 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 1 | 9 | 0 | 10 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for ETHICON, INC. recalls
What to do if you have a recalled ETHICON, INC. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All ETHICON, INC. recalls
26 shown- Lower riskMedical device
ETHICON, INC. recalls MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue
Ethicon recalls Monocryl" sutures with incorrect needle type or size due to manufacturing mix-up. Affected products may have wrong suture length. Consumers should check product details and contact Ethicon for remedy.
EthiconOct 8, 2024 - Lower riskMedical device
Ethicon, Inc. recalls Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Ethicon recalls coated VICRYL Polyglactin 91:0 suture due to needle pull-off and visible degradation in packaging. Affected units may have compromised strength.
EthiconSep 25, 2024 - Use cautionMedical device
Ethicon, Inc. recalls PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in
Ethicon recalls PDS Plus Antibacterial sutures with packaging holes that could cause infection. Product codes PDP304H, PDP316H, PDP341H lots TLMJLZ, UAMKDC, UBMCZA affected. Stop using if you have these items.
EthiconMay 10, 2024 - Lower riskMedical device
Ethicon, Inc. recalls SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Ethicon recalls SURGIFOAM Absorbable Gelatin Powder Kit (Product Code 1979) due to open seals in some applicator tips. Affected lots include 272574, 272369, and 2:72770. Consumers should check their product labels.
EthiconApr 23, 2024 - Lower riskMedical device
Ethicon, Inc. recalls STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD
Ethicon recalls STRATAFIX Spiral Monocryl Plus devices that may have lost sterility during shipping, risking infection. Affected units were shipped with foil pouches that degraded due to environmental exposure.
EthiconMar 8, 2024 - Lower riskMedical device
Ethicon, Inc. recalls PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use
Ethicon recalls PDS Plus antibacterial sutures that may break during surgery, risking poor tissue repair. Affected products include specific sizes and lot numbers. Consumers should contact Ethicon for details.
EthiconMar 31, 2023 - Stop using nowMedical device
Ethicon, Inc. recalls PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue
Ethicon recalls violet monofilament PDS II sutures with low knot strength that could break during surgery. Affected units have product code Z340H and expire February 2027. Stop using immediately.
EthiconNov 16, 2022 - Lower riskMedical device
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
Ethicon recalls STRATAFIX SPIRAL sutures that may contain a PS-1 needle instead of the intended SH taper point needle, potentially causing more tissue trauma. Affected products have specific product numbers and expiry dates.
EthiconSep 20, 2022 - Use cautionMedical device
Ethicon, Inc. recalls PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Ethicon recalls PDS II sutures with possible incorrect material that could impact treatment. Consumers should check product details and contact Ethicon for guidance.
EthiconAug 8, 2022 - Lower riskMedical device
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
Ethicon recalls specific STRATAFIX Spiral PGA-PCL sutures due to possible incorrect needle size or length in some lots. Affected products may cause improper surgical use if not checked.
EthiconMar 24, 2022 - Lower riskMedical device
Ethicon, Inc. recalls Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of
Ethicon recalls Dermabond Advanced Topical Skin Adhesive due to potential sterility breach from red packaging tape. Affected units have specific product codes and expiration dates.
EthiconJan 4, 2021 - Lower riskMedical device
Ethicon, Inc. recalls PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Ethicon recalls hernia mesh oval (15cm x 20cm) due to hair found in packaging. Consumers should check product codes and contact Ethicon for details.
EthiconOct 23, 2020 - Lower riskMedical device
Ethicon, Inc. recalls VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic
Ethicon recalls VICRYL monofilament sutures that may have wrong size (6-0 vs 10-0) for eye surgery. Incorrect sutures could lead to improper wound closure. Affected products sold between 2020-2024.
EthiconSep 9, 2020 - Lower riskMedical device
Ethicon, Inc. recalls PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782
Ethicon recalls Perma-Hand and Virgin Silk Blue sutures with product codes EH7457G and others due to potential shelf life issues beyond 5 years.
EthiconJun 10, 2020 - Lower riskMedical device
Ethicon, Inc. recalls Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile
Ethicon recalls Coated VICRYL (Polyglactin : 18" sutures with lot number PGZ908 may have frayed sections that could reduce tensile strength during surgery.
EthiconJan 3, 2020 - UnratedMedical device
Ethicon, Inc. recalls 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
Ethicon recalls 1 STRATAFIX Spiral PDS Plus Violet 18" OS-6 needles (lot PAH360) due to not meeting internal testing specs. No remedy stated in official notice.
EthiconAug 28, 2019 - Lower riskMedical device
Ethicon, Inc. recalls STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Ethicon recalls STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle sutures due to failing internal strength tests. Affected products have product code SXPP1B401 and lot number MMH401. Consumers should contact Ethicon for details.
EthiconAug 13, 2019 - Lower riskMedical device
Ethicon, Inc. recalls ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND
Ethicon recalls ETHIBOND EXCEL polyester suture (Product Code X42: PBQ426) because it may contain high endotoxin levels. This could pose a risk during medical procedures.
EthiconApr 19, 2019 - UnratedMedical device
Ethicon, Inc. recalls PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation,
Ethicon recalls PDS II Sutures 18" 2-0 VIO (Product Code Z739D) due to potential mismatch between product and labeling. Affected items may have incorrect materials.
EthiconMar 12, 2019 - Lower riskMedical device
Ethicon, Inc. recalls PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND*
Ethicon recalls PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles (Product Code 485T) due to incorrect suture size in packaging. This could lead to improper use during medical procedures.
EthiconDec 18, 2018 - Lower riskMedical device
Ethicon, Inc. recalls PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G
Ethicon recalls PDS Plus Antibacterial Suture (PDP493G) due to insufficient tensile strength. Affected units may fail during use, risking complications. Contact Ethicon for details.
EthiconJun 8, 2018 - Lower riskMedical device
Ethicon, Inc. recalls PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
Ethicon recalls PROLENE Suture Monobundle (BV1755 Taper Point 3/8C, D10031) due to packaging perforation risk. Perforated packaging may cause soft tissue injury or patient infection if sterility is breached.
EthiconMay 7, 2018 - UnratedMedical device
Ethicon, Inc. recalls Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL
Ethicon recalls 45cm flexible tip accessory set (EVT45) distributed in US. Products labeled for outside US may have been sold here. No remedy specified in recall notice.
EthiconMar 7, 2018 - Lower riskMedical device
Ethicon, Inc. recalls PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Ethicon recalls PDS Plus Antibacterial Suture with incorrect 5-year expiry label instead of 2-year. Affected lots may expire prematurely.
EthiconJan 10, 2018 - Lower riskMedical device
Ethicon, Inc. recalls DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only
Ethicon recalls DERMABOND PRINEO Skin Closure System that may fall off if not dried within specified time after application. This could lead to wound reopening. Consumers should check product lot numbers and contact Ethicon for details.
EthiconNov 27, 2017 - Lower riskMedical device
Ethicon, Inc. recalls Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Ethicon recalls specific lots of Coated VICRYL RAPIDETM (Polyglactin 910) Suture due to identified suture damage and failed knot tensile strength testing.
EthiconAug 17, 2017
ETHICON, INC. recall questions
How many recalls has ETHICON, INC. had?
59 recalls from ETHICON, INC. are on record with U.S. safety agencies, from 2017–2024.
What is the most recent ETHICON, INC. recall?
ETHICON, INC. recalls MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue, dated Oct 8, 2024. Every ETHICON, INC. recall is listed on this page, newest first.
Why are ETHICON, INC. products recalled?
The most common reasons on record: Products do not meet a tensile strength specification (3); The product do not meet certain internal testing specifications. (3); The product does not meet certain internal strength testing specifications. (2).
What should I do if I have a recalled ETHICON, INC. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new ETHICON, INC. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.