--- title: "ETHICON, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search ETHICON, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/ethicon-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # ETHICON, LLC recall records **6** reported ongoing 6 records in this archive. Latest source date Aug 15, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 15, 2025 FDA device enforcement ### [STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.](https://isitonrecall.com/recall/fda-device-z-2605-2025-stratafix-spiral-pds-plus-bidirectional-knotless-tissue-control-device-sfx-spi-pds-bi-vio-14x14in-36/) Potential for barb non-engagement. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI and the countries of Singapore and Malaysia. [Official source for STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2605-2025%22) Dec 20, 2024 FDA device enforcement ### [PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in...](https://isitonrecall.com/recall/fda-device-z-1096-2025-prolene-polypropylene-suture-ref-eh7585h-8706h-8833h-8963h-8935h-prolene-suture-is-indicated-for-use/) 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 cause infection. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, ... [Official source for PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicate...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1096-2025%22) Dec 20, 2024 FDA device enforcement ### [PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardio...](https://isitonrecall.com/recall/fda-device-z-1097-2025-perma-hand-silk-suture-ref-k872h-w723h-623h-k833h-perma-hand-silk-suture-is-indicated-for-use-in-gen/) 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 cause infection. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, ... [Official source for PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for u...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1097-2025%22) Dec 20, 2024 FDA device enforcement ### [ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US](https://isitonrecall.com/recall/fda-device-z-1098-2025-ethibond-excel-polyester-suture-ref-6664h-x425h-x872h-eh7491h-not-sold-in-us/) 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 cause infection. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, ... [Official source for ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1098-2025%22) Aug 10, 2023 FDA device enforcement ### [PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP4...](https://isitonrecall.com/recall/fda-device-z-2616-2023-pds-plus-antibacterial-polydioxanone-suture-product-numbers-pdp072h40-pdp259h50-pdp416h50-pdp441h50/) Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. Class II Reported ongoing Distribution: US Nationwide. Global Distribution. [Official source for PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, P...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2616-2023%22) Aug 10, 2023 FDA device enforcement ### [PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50...](https://isitonrecall.com/recall/fda-device-z-2617-2023-pds-ii-polydioxanone-suture-product-numbers-z844g-50-d10065-05-d10085-05-d6776-05-d6776-05-d9297-05/) Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. Class II Reported ongoing Distribution: US Nationwide. Global Distribution. [Official source for PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2617-2023%22) ## Reasons in these listed records - Potential for barb non-engagement. - 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 cause infection. - Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement. These examples come from this result page and are not a ranking of every recall reason. ## Checking ETHICON, LLC ### Is there a recall on ethicon, llc right now? This archive contains 6 records, including 6 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search ETHICON, LLC](https://isitonrecall.com/check/?q=ETHICON%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)