The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2024-2014·Announced 2014-07-16

Aesculap Recalls Non-Sterile Sutures With Conflicting Sterile Labeling

Aesculap is recalling 11 units of non-sterile Dafilon sutures because an additional label incorrectly states the product is sterile.

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: This is a voluntary precautionary recall for a labeling error (mis-labeling) without reported injuries or illnesses, fitting the criteria for a Moderate severity score.

Plain-English summary

Aesculap, Inc. has initiated a voluntary recall of 11 units of Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS. These are non-sterile, non-absorbable polyamide surgical sutures packaged in cassettes holding 12 sutures each.

The recall is due to a labeling discrepancy. While the primary box labels correctly identify the product as non-sterile, an additional label affixed to the box incorrectly states that the product is sterile. This conflicting information could lead to improper handling or use of the medical device.

The affected units were distributed in Illinois, New York, Georgia, and Rhode Island. The specific lot numbers involved are 1-6375, 1-8473, 1-8433, 1-9384, 110054, and 110055. Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the product if found.

The recalled product

Product
Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
Manufacturer
Aesculap, Inc.
Category
Medical Device — Surgical Sutures
Hazard
Affected units
11

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 Numbers: 1-6375 1-8473 1-8433 1-9384 110054 110055

Distribution

Distributed in 4 states:

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