The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1136-2019·Announced 2019-04-24

Ethicon Recalls VICRYL and PDS Sutures Due to Labeling Mismatches

Ethicon, Inc. is recalling VICRYL, VICRYL Plus, and PDS sutures because the product inside may not match the sales unit carton and foil label.

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 due to a labeling mismatch that could lead to the use of the wrong product, but no specific injuries or illnesses are reported in the source text, fitting the criteria for moderate severity involving labeling errors.

Plain-English summary

Ethicon, Inc. is recalling VICRYL Suture, VICRYL Plus Suture, and PDS Suture products. The recall is issued because the medical device contained in the packaging may not match the product identified on the sales unit carton and foil label. This discrepancy could result in the use of an unintended suture type or size during surgical procedures.

The recall involves 550,681 units of PDS II Suture 18"(45CM) 2-0 VIO, specifically Lot Code MGM110. The distribution pattern is worldwide, including the United States, Australia, Belgium, Canada, China, Israel, Japan, Puerto Rico, and Singapore. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Healthcare providers and facilities should stop using the affected suture products and check their inventory for the specific lot code and product codes listed in the recall notice. Patients who have had surgery using these products should contact their healthcare provider if they have concerns about the specific suture used.

The recalled product

Product
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular…
Manufacturer
Ethicon, Inc.
Category
Medical Device — Surgical Sutures
Hazard
Affected units
550,681

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)

  • Lot Code: MGM110

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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