Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Take action
Contact the company
📍Recalling firmEthicon, Inc.Us Highway 22 West · Somerville, NJ 08876
“Ethicon PDS Plus Suture: Incorrect Expiry Date Recall.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72153-ethicon-pds-plus-suture-incorrect-expiry-date-recall. Based on FDA recall #Z-1338-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1338-2018%22&limit=1).
Ethicon, Inc. recalled PDS Plus Antibacterial Suture Size 0 with incorrect expiry dates on the label, according to the FDA. The Food and Drug Administration announced the Class II recall on Jan. 10, 2018.
How to tell if you have it
Brand: Ethicon
Product: PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
UPC: 10705031048126
Lot code: LL6459
Units affected: 7,020
The hazard
Three lots were distributed with an incorrect expiry date on the label. The lots were labeled with an expiry date of five years from date of manufacture instead of the correct expiry date of two years from date of manufacture.
Context
GovInfoNow's records show Ethicon, Inc. has had 25 other recalls since Aug. 17, 2017. Recent Ethicon recalls include a Monocryl Sutures recall on Oct. 8, 2024, and a Coated VICRYL Suture recall on Sept. 25, 2024. Other recent recalls of similar products include an Expressaire Disposable Tourniquet Cuff recall (Aug. 24, 2026), a Cook Medical Multipurpose Drainage Catheter recall (March 5, 2026), and a B Braun Discofix Four Way Stopcock recall (Aug. 4, 2026).
How to tell if you have this one
Check for the product code PDP346H and GTIN 10705031048126. The affected lot number is LL6459 with an incorrect expiry date label.
Brand
Ethicon
Product
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Category
Medical device
FDA recall event · 3 products
All 3 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
Terminated
Distribution
Distribution US Nationwide, Canada, India, and Colombia.
Recall number
Product, codes & lots
Quantity
Z-1338-2018
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle; Product code: PDP346H GTIN: 10705031048126 Product lot: LL6459
7020
Z-1339-2018
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle; Product code: PDP695H GTIN: 10705031048584 Product lot: LL6590
72
Z-1340-2018
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle; Product code: PDPB346 GTIN: 10705031048829 Product lot: LMM273
180
Based on the official FDA remedy
What to do — step by step
Check Expiry Date
Verify the expiry date on the label matches the correct 2-year period from manufacture date.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution US Nationwide, Canada, India, and Colombia.” 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 terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1338-2018 (January 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1338-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.