Surgical Kits Recalled Due to Glove Splits Compromising Sterility
The FDA is recalling 114,813 surgical kits containing Devon Light Gloves due to splits or holes that compromise sterility.
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. The hazard involves compromised sterility in surgical kits, which poses a risk of infection (risk-of-harm), but the source text does not report specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 114,813 surgical kits manufactured by Covidien LLC. These sterile kits contain Devon Light Gloves that have been found to contain splits or holes, which compromises the sterility of the product.
The affected products are distributed worldwide, including the United States (nationwide), the Virgin Islands, Canada, Australia, New Zealand, and numerous other countries. The recall applies to kits with lot numbers beginning with 508xxxx or lower. Specific catalog numbers affected include 573326, 573328, 573343, 573346, 573359, 573368, 573776, 573777, 573798, 31144507, 31175089, 31321097, 31451480, 31460432, 50000947, 50001029, and 50001052.
Healthcare facilities and distributors should stop using these kits and contact the recalling firm for instructions on return or disposal. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368…
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 114,813
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 number begins 508xxxx or lower
Distribution
Part of a larger recall action
This product is one of 14 recalled by Covidien LLC 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.
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