Ethicon recalls
13 official recalls and safety alerts involving Ethicon since 2022-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Ethicon or the relevant agency.
- 2025-10-01
USETHICON, LLC recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product…
Potential for barb non-engagement.
FDA · DeviceETHICON, LLCWorldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN,…Official notice →- 2025-02-12
- US
Ethicon, LLC recalls PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue…
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…
FDA · DeviceEthicon, LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2024-11-27
- US
ETHICON, INC. recalls MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or…
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
FDA · DeviceETHICON, INC.U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,…Official notice → - 2024-11-13
- US
Ethicon, Inc. recalls Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
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.
- 2024-06-26
- US
Ethicon, Inc. recalls PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric…
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
FDA · DeviceEthicon, Inc.Worldwide distribution - US Nationwide including PR and the countries of AR,…Official notice → - 2024-05-29
- US
Ethicon, Inc. recalls SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Some applicator tips from these lots had open seals.
FDA · DeviceEthicon, Inc.US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY,…Official notice → - 2024-04-24
- US
Ethicon, Inc. recalls STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM)…
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
- 2023-09-27
- US
ETHICON, LLC recalls PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50,…
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
- 2023-05-17
- US
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 general soft…
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
FDA · DeviceEthicon, Inc.International distribution in the countries of United Kingdom, Ireland and…Official notice → - 2022-12-21
- US
Ethicon, Inc. recalls PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use…
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
FDA · DeviceEthicon, Inc.International (OUS) only: Canada, Japan, Australia and New ZealandOfficial notice → - 2022-11-09
- US
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 absorbable sutures…
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
- 2022-09-28
- US
Ethicon, Inc. recalls PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Product may contain the incorrect material which could impact treatment.
- 2022-05-18
- US
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 PS-1, product code:…
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.