Agency classClass IIOur severity:High FDA (Devices)·Z-1180-2023·Announced 2023-03-08

Surgipro II Surgical Sutures recalled for sterile barrier breach

Covidien is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch that may cause infection or vision loss in ophthalmic procedures with direct patient contact.

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: This is a Class II FDA recall for a sterile barrier breach in surgical sutures. While infection and vision loss are serious potential harms, no illnesses or injuries have been reported in the source material, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Covidien, LP is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch. This breach may compromise sterility of the sutures, potentially causing infection or vision loss in ophthalmic procedures where the sutures come into direct patient contact.

The recall affects 322,152 units distributed nationwide in the United States and to over 50 countries internationally. Multiple model numbers and specific lot codes are included in the recall.

Healthcare providers using these sutures should verify whether they have received affected products using the provided lot numbers and model codes. Patients who have had ophthalmic procedures with these sutures should contact their healthcare provider if they have concerns about potential infection or vision changes.

The recalled product

Product: Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X…
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Sutures
Hazard: sterile-barrier-breach
infection-risk
vision-loss
Affected units: 322,152

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Covidien, LP 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 11 products in this recall →

Same manufacturer · Covidien, LP

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Same hazard · sterile barrier breach