Use cautionMedical device recall · FDA · Published May 10, 2024
Ethicon PDS Plus Suture Recall: Packaging Hole Risk of Infection
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.
“Ethicon PDS Plus Suture Recall: Packaging Hole Risk of Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55128-ethicon-pds-plus-suture-recall-packaging-hole-risk-of-infection. Based on FDA recall #Z-2147-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2147-2024%22&limit=1).
Ethicon, Inc. recalled PDS Plus Antibacterial sutures on May 10, 2024, because a packaging machine error compromised sterility and could cause infection, the FDA said. The voluntary Class II recall affects worldwide distribution.
How to tell if you have it
PDS Plus Antibacterial (polydioxanone) Suture
Product codes: PDP304H, PDP316H, PDP341H
Lot codes: TLMJLZ (PDP304H), UAMKDC (PDP316H), UBMCZA (PDP341H)
The FDA said an issue on a specific packaging machine resulted in a hole in the primary packaging. This compromised product sterility and could result in infection.
Context
GovInfoNow's records show ETHICON, INC. has 25 other recalls on record since 2017-08-17. Other recent recalls of similar products include Ethicon Monocryl Sutures Recall (2024-10-08), Ethicon Coated VICRYL Suture Recall (2024-09-25), and Ethicon SURGIFOAM Absorbable Gelatin Powder Kit Recall (2024-04-23). Other recent recalls of similar products include Covidien Dermalon 4-0 Blue 75cm Sutures Recall (2026-06-24), Covidien Surgipro II S8698GX (2026-06-24), and Covidien Surgipro SP-623 Sutures (2026-06-24).
How to tell if you have this one
Check for product codes PDP304H, PDP316H, or PDP341H with lots TLMJLZ, UAMKDC, or UBMCZA. These sutures were sold with the specific packaging defect.
Brand
Ethicon
Product
PDS Plus Antibacterial (polydioxanone) Suture
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
Recall number
Product, codes & lots
Quantity
Z-2144-2024
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H; UDI-DI: N/A PRODUCT CODE PRODUCT LOTS J214H UAMPJQ J218H UBMJSK J258H UBMHSJ J268H UBMLPP J269H UAMMAH UAMRMU J327H UAMPEP J344H UBMHRU J345H UAMJPK UAMPKD J370H UAMMJT J416H UAMRSJ UAMRHB J417H UAMLMX J426H UAMQRQ UBMCAC UBMCML UBMCRD J427H UAMRPR J458H UAMQRT J493H UAMMKE J603H TPMBSX UAMLXC UAMMBQ J699H UAMQME J936H UAMMSL J978H UAMKBD UAMHTE
341532 units
Z-2145-2024
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H; GTIN: 10705031051546 10705031052147 10705031053038 10705031054370 10705031054394 10705031054677 10705031150492 10705031056329 10705031056725 10705031150119 10705031150287 10705031150447 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA
55296 units
Z-2146-2024
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H; GTIN 10705031026216 10705031060166 10705031060289 10705031060395 10705031060517 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA
56952 units
Z-2147-2024
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H; GTIN: 10705031047976 10705031048027 10705031048119 PRODUCT CODE PRODUCT LOTS PDP304H TLMJLZ PDP316H UAMKDC PDP341H UBMCZA
Identify your suture's product code and lot number to confirm if it's affected.
Stop Using If Affected
If you have the recalled product codes and lots, stop using them immediately to avoid infection risk.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2147-2024 (May 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2147-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.