The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1339-2018·Announced 2018-04-18

Ethicon Recalls PDS Plus Sutures Due to Incorrect Expiry Date Labeling

Ethicon, Inc. is recalling PDS Plus Antibacterial Sutures because three lots were labeled with a five-year expiry date instead of the correct two-year date.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding the expiry date, which is a documentation issue rather than a direct physical defect or contamination.

Plain-English summary

Ethicon, Inc. is recalling PDS Plus Antibacterial (Polydioxanone) Sutures, Size 1, Single Armed OS-4 Needle. The recall involves 72 units of product code PDP695H, GTIN 10705031048584, and lot LL6590.

The recall was initiated because three lots were distributed with an incorrect expiry date on the label. The labels indicated an expiry date of five years from the date of manufacture, whereas the correct expiry date is two years from the date of manufacture.

The affected products were distributed in the United States, Canada, India, and Colombia. Consumers and healthcare providers should stop using the affected lots and contact Ethicon, Inc. for further instructions.

The recalled product

Product
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Manufacturer
Ethicon, Inc.
Category
Medical Device — Sutures
Hazard
Affected units
72

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product code: PDP695H GTIN: 10705031048584 Product lot: LL6590

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Ethicon, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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