The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1593-2022·Announced 2022-08-31

Mckesson Ultracell Eye Pledgets Recalled Over Temperature Exposure During Storage

Mckesson Medical-Surgical is recalling Ultracell Eye Pledgets (Model 40825) due to temperature excursions during storage and transportation between June and August 2021 that may have compromised product effectiveness. Affected units were distributed nationwide from June through September 2021.

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 sterile medical device where temperature excursions during storage may have compromised product effectiveness. It meets the criterion for a risk-of-harm product where injury has not yet been reported. Although classified as FDA Class II, no hospitalization or injury reports are documented, placing it below the Severe threshold but above Moderate due to the inherent risk associated with compromised sterile surgical devices.

Plain-English summary

Mckesson Medical-Surgical Inc. is recalling Ultracell Eye Pledgets (Model 40825), sterile surgical medical devices used in ophthalmic procedures. The recall affects all units distributed in the United States between June 1, 2021, and September 30, 2021.

The recalled products were stored in facilities where temperature excursions occurred between June and August 2021, prior to delivery. Exposure to temperatures higher than intended may have impacted the product's effectiveness and ability to perform as designed during surgical use.

No illnesses or injuries related to this recall have been reported. Patients who have received this device or healthcare providers with inventory of affected lots should contact Mckesson Medical-Surgical Inc. for instructions on obtaining replacements or for additional information.

The recalled product

Product
Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Medical Device — Surgical / Ophthalmic
Hazard
Affected units
2

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 (2)

  • GTIN: 00886158012108
  • 30886158012109

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 55 products in this recall →

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