Agency classClass IIOur severity:High FDA (Devices)·Z-2918-2026·Announced 2026-08-19

V-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects

Covidien, LP is recalling V-Loc 90 Absorbable Wound Closure Devices due to potential sterile barrier packaging defects that may cause biocontamination.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (infection, loss of vision) from a sterile barrier defect, but the source text does not report any actual illnesses or injuries, placing it in the High severity category.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for V-Loc 90 Absorbable Wound Closure Devices manufactured by Covidien, LP. The recall involves 135,875 units distributed nationwide in the United States and in numerous international countries, including Australia, Canada, and various European and Asian nations.

The recall was initiated because the product may contain a perforation or tear in the sterile barrier packaging. This defect may result in the biocontamination of the sterile sutures. If used, the contamination may lead to infection, loss of vision if utilized in ophthalmic procedures, or prolonged surgery.

Healthcare providers and facilities should check their inventory for the specific lot numbers and UDI-DI codes listed in the official recall notice. Affected units should be quarantined and returned to the manufacturer or their authorized distributor in accordance with the recall instructions.

The recalled product

Product: V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM…
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Sutures
Hazard: infection
loss-of-vision
packaging-defect
Affected units: 135,875

Distribution

Distributed nationwide across the United States.

Same manufacturer · Covidien, LP

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